International Guideline Pressure Ulcer Treatment Technical Report

International
Guideline
Pressure Ulcer Treatment
Technical Report
©National Pressure Ulcer Advisory Panel & European Pressure
Ulcer Advisory Panel
2009
Treatment Technical Report
Table of Contents
Foreword. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
Suggest Citation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
Limitations and Appropriate Use of This Guideline . . . . . . . .. . . . . . . . . . . 3
Abstract . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Guideline Developers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Acknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Executive Summary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Methodology for Guideline Development. . . . . . . . . . . . . . . . . . . . . . . . .. 20
International NPUAP-EPUAP Pressure Ulcer Classification System . . . . 29
Pressure Ulcer Treatment Tables
Classification of Pressure Ulcers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Assessment and Monitoring of Healing . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Role of Nutrition in Pressure Ulcer Healing . . . . . . . . . . . . . . . . . . . . . . . 50
Pain Assessment and Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Support Surfaces for Treatment of Pressure Ulcers . . . . . . . . . . . . . . . . . 74
Cleansing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .79
Debridement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83
Dressings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .99
Assessment and Treatment of Infection . . . . . . . . . . . . . . . . . . . . . . . . ..117
Biophysical Agents in Pressure Ulcer Management . . . . . . . . . . . . . . . . 124
Growth Factors for Pressure Ulcer Treatment . . . . . . . . . . . . . . . . . . . . 134
Surgery for Pressure Ulcers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .140
Pressure Ulcer Management in Individuals Receiving Palliative Care . 160
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Treatment Technical Report
Foreword
The International Pressure Ulcer Guideline summarizes recommendations and
supporting evidence for pressure ulcer prevention and treatment. It was
developed as a 4-year collaborative effort between the European Pressure
Ulcer Advisory Panel (EPUAP) and American National Pressure Ulcer Advisory
Panel (NPUAP). It provides a detailed analysis and discussion of available
research, critical evaluations of the assumptions and knowledge of the field, a
description of the methodology used to develop the guideline, and the
acknowledgments of editors, authors, and other contributors.
The Clinical Practice Guideline is intended for professionals interested in both
the recommendations for pressure ulcer care and the scientific evidence
supporting those recommendations. A Quick Reference Guide version is also
available that contains excerpts from the Clinical Practice Guideline. The Quick
Reference Guide version is intended for busy clinicians who need a “quick”
reference in caring for individuals with pressure ulcers and/or who are at risk
for developing pressure ulcers. Users should not rely on these excerpts alone.
This Pressure Ulcer Treatment Technical Report includes the evidence tables
used as a basis for guideline development. It is intended for researchers,
educators and clinicians who wish to more fully explore the research
supporting the treatment recommendations and evidence summaries
presented in the Clinical Practice Guideline.
Printed copies of the English editions of the Clinical Practice Guideline and
Quick Reference Guide are available through the NPUAP website
(www.npuap.org). The Quick Reference Guide has been translated into several
languages; translations are available on the EPUAP website (www.epuap.org).
The Prevention Technical Report and Treatment Technical Report are only
available in electronic version from NPUAP (www.npuap.org) and EPUAP.
The goal of this international collaboration was to develop evidence-based
recommendations for the prevention and treatment of pressure ulcers that
could be used by health care professionals throughout the world. An explicit
scientific methodology was used to identify and evaluate available research.
In the absence of definitive evidence, expert opinion (often supported by
indirect evidence and other guidelines) was used to make recommendations.
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Guideline recommendations were made available to 903 individuals and 146
societies/organizations registered as stakeholders in 63 countries on 6
continents. The final guideline is based on the available research and the
accumulated wisdom of the EPUAP, NPUAP, and international stakeholders.
Suggested Citation
The EPUAP and NPUAP welcome the use and adaptation of this guideline at a
national and local level. However, we request citation as to the source, using
the following format:
National Pressure Ulcer Advisory Panel and European Pressure Ulcer Advisory
Panel. Pressure Ulcer Treatment: Technical Report. Washington DC: National
Pressure Ulcer Advisory Panel; 2009. Available at www.npuap.org.
Limitations and Appropriate Use of This Guideline
• Guidelines are systematically developed statements to assist practitioner
and patient decisions about appropriate health care for specific clinical
conditions. The recommendations may not be appropriate for use in all
circumstances.
• The decision to adopt any particular recommendation must be made by the
health care professional in light of available resources and circumstances
presented by the individual patient. Nothing contained in this guideline is to
be considered medical advice for specific cases.
• Because of the rigorous methodology used to develop this guideline, the
NPUAP and EPUAP believe that the research supporting these
recommendations is reliable and accurate. However, we do not guarantee the
reliability and accuracy of individual studies referenced in this document.
• This guideline and any recommendations herein are intended for
educational and informational purposes only.
• This guideline contains information that was accurate at the time of
publication. Research and technology change rapidly and the
recommendations contained in this guideline may be inconsistent with future
advances. The health care professional is responsible for maintaining a
working knowledge of the research and technological advances that may
affect his/her practice decisions.
• Generic names of products are provided. Nothing in this guideline is
intended as an endorsement of a specific product.
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• Nothing in this guideline is intended as advice regarding coding standards or
reimbursement regulations.
Abstract
This guideline is the result of a collaborative effort between the American
National Pressure Ulcer Advisory Panel (NPUAP) and European Pressure Ulcer
Advisory Panel (EPUAP). A comprehensive literature review was conducted on
pressure ulcer prevention and treatment. A rigorous scientific methodology
was used to analyze available research and to make evidence-based
recommendations for the prevention and treatment of pressure ulcers. Drafts
of the guideline were made available to 903 individuals and 146
societies/organizations registered as stakeholders in 63 countries on 6
continents. All stakeholder comments were carefully considered by guideline
developers. Explicit recommendations and summaries of supporting evidence
are provided for the following aspects of pressure ulcer prevention: etiology,
risk assessment, skin assessment, nutrition, repositioning, support surfaces,
and special pressure ulcer preventive needs of patients in the operating room.
Recommendations and research were also summarized for a wide variety of
topics related to pressure ulcer treatment: classification of pressure ulcers,
assessment and monitoring of healing, the role of nutrition in healing, pain
assessment and management, support surfaces, principles of wound bed
preparation (i.e., cleansing, debridement, dressing selection, assessment and
treatment of infection), biophysical agents (e.g., electrical stimulation,
negative pressure wound therapy), surgery, and management in individuals
receiving palliative care. The NPUAP and EPUAP also agreed on an
international classification system for pressure ulcers with the hope that it
will be adopted internationally and therefore help reduce discrepancies in
international reporting of pressure ulcer incidence and prevalence.
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Guideline Development Group
EPUAP
Carol Dealey, PhD, RN (EPUAP Chair)
Research Development Team,
University Hospital Birmingham, NHS Foundation Trust,
Birmingham, United Kingdom
Michael Clark, PhD
Wound Healing Research Unit, Cardiff University,
Cardiff, United Kingdom
Tom Defloor, PhD, RN
Nursing Science, Ghent University, Ghent, Belgium
Lisette Schoonhoven, PhD, RN
Nursing Science, St Radboud University,
Nijmegen, The Netherlands
Katrien Vanderwee, PhD, RN
Nursing Science, Ghent University, Ghent, Belgium
Anne Witherow, RN
Associate Director of Nursing, Western Health and Social
Care Trust, Northern Ireland
NPUAP
Janet Cuddigan, PhD, RN CWCN
(NPUAP Co-Chair & Editor-in-Chief)
University of Nebraska Medical Center, Omaha, NE, USA
Diane K. Langemo, PhD, RN, FAAN
(NPUAP Co-Chair)
University of North Dakota, Grand Forks, ND, USA
Mona M. Baharestani, PhD, ANP, CWON, CWS
East Tennessee State University, Johnson City, TN, USA
James H. Quillen
Veterans Affairs Medical Center, Johnson City, TN, USA
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Joyce Black, PhD, RN, CWCN, CPSN
University of Nebraska Medical Center, Omaha, NE, USA
Evan Call, MS
Weber State University, Centerville, UT, USA
Mary Ellen Posthauer, RD, CD, LD
Supreme Care West, LLC, Evansville, IN, USA
Consultants
Steven Black, MD, FACS served as a medical consultant to the Guideline Development
Group. Dr. Black is a plastic surgeon at The Nebraska Medical Center, Omaha, NE, USA.
Phillip Smith, MD served as a consultant on the assessment and management of
infection. Dr. Smith is a Professor in Internal Medicine and Chief of the Infectious
Diseases Section at the University of Nebraska Medical Center in Omaha, NE, USA. He
is a Fellow of the American College of Physicians and the Infectious Diseases Society of
America.
Small Working Group (SWG) Members
Prevention
Aetiology: Cees Oomens (Leader), José Verdu Soriano, Dan Bader & Amit Gefen • Risk
Assessment: Jane Nixon (Leader), Jacqui Fletcher, Alexander Heyneman, Helvi
Hietanen, Jeannie Donnely, Khryz Gebhardt, Maureen Benbow, Zena Moore & Katrien
Vanderwee • Skin Assessment: Carol Dealey (Leader), Katrien Vanderwee, Lisette
Schoonhoven, Tom Defloor • Nutrition for Pressure Ulcer Prevention: Jos Schols
(Leader), Ruud Halfens, Pam Jackson, Gero Langer, Judith Meijers & Hilde Heyman •
Repositioning for Prevention of Pressure Ulcers: Zena Moore (Leader), Trudie Young,
Anna Polak & Hilde Heyman • Support Surfaces: Lena Gunningberg (Leader), Andrea
Bellingeri, Paulo Alves, Mark Collier, Katia Furtado, Jan Weststrate & Erik de Laat •
Special Population: Patients in the Operating Room: Lisette Schoonhoven (Leader)
Lena Gunningberg (Leader), Andrea Bellingeri, Paulo Alves, Mark Collier, Katia Furtado,
Jan Weststrate & Erik de Laat
Treatment
Classification of Pressure Ulcers: Joyce Black (Leader), Janet Cuddigan, Tom Defloor &
Courtney Lyder • Assessment & Monitoring of Healing: Janet Cuddigan (Leader),
Susan Garber & Diane Langemo • Role of Nutrition in Pressure Ulcer Healing: Mary
Ellen Posthauer (Leader), Becky Dorner, David Thomas & Steven Black • Pain
Assessment & Management: Diane Langemo (Leader) & Barbara Bates-Jensen •
Support Surfaces for Treatment of Pressure Ulcers: Evan Call (Leader), Joyce Black,
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Steven Black, David Brienza, Janet Cuddigan, Kim Davis, Susan Garber, Diane Langemo
& Steven Reger • Wound Bed Preparation & Biofilms: Greg Schultz • Cleansing:
Catherine Ratliff (Leader), George Rodeheaver & Greg Schultz • Debridement: Mona
Baharestani (Leader), Steven Black & Carrie Sussman • Dressings: Joyce Black (Leader),
Laurie McNichol (Leader) & Karen Zulkowski (Leader), Sharon Baranoski, Barbara
Bates-Jensen & Joann Maklebust • Assessment & Treatment of Infection: Catherine
Ratliff (Leader), Joyce Black, Janet Cuddigan, George Rodeheaver & Greg Schultz •
Biophysical Agents in Pressure Ulcer Management: Teresa Conner-Kerr (Leader),
Carrie Sussman, Luther Kloth, Laura Edsberg & Diane Langemo • Negative Pressure
Wound Therapy: Joyce Black & Laurie McNichol • Biological Dressings & Growth
Factors: Laura Edsberg (Leader), Harold Brem, Aimee` Garcia & Greg Schultz • Surgery
for Pressure Ulcers: Steven Black (Leader), Joyce Black & Harold Brem • Pressure Ulcer
Management in Individuals Receiving Palliative Care: Diane Langemo (Leader) &
Barbara Bates-Jensen, with assistance from Steven Antokal & Nicole Hayes
Acknowledgments
The European Pressure Ulcer Advisory Panel (EPUAP) and National Pressure
Ulcer Advisory Panel (NPUAP) gratefully acknowledge the contributions of the
following individuals and groups for financially supporting the presentation
and dissemination of the guideline. All financial contributions were made
after the guideline was developed and in no way influenced the development
of the guideline or its content. Financial contributions are being used for the
printing and dissemination of the guideline. The following companies
provided unrestricted education grants:
NPUAP Donors
Platinum Level Contributor ($20,000 or greater)
Kinetic Concepts, Inc
Gold Level Contributor ($10,000 to $19,999)
American Medical Technologies, Inc
Silver Level Contributors ($1,000 to $9,999)
Coloplast
EHOB, Incorporated
Genesis HealthCare
HCR ManorCare
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Nestlé Nutrition
Smith & Nephew
Bronze Level Contributor ($1,000 or less)
SAM Medical Products
EPUAP Donors
ArjoHuntleigh, Europe
Hill-Rom, Europe
Nutricia Advanced Medical Nutrition
Kinetic Concepts, Inc
In Kind Contributions
 McGoogan Library, University of Nebraska Medical Center, Omaha,
NE, USA (database searches by a professional librarian & interlibrary
loan services)
 College of Nursing, University of Nebraska Medical Center, Omaha,
NE, USA
 World Union of Wound Healing Societies and the University of
Toronto, Toronto, CA (initial database searches)
 The Registered Nurses of Ontario, Royal College of Nursing,
Consortium on Spinal Cord Injury Medicine, Agency for Health Care
Policy and Research (now AHRQ) provided evidence tables used to
support previous guidelines.
 Eran Ganz-Lindgren reviewed an article written in Hebrew.
Stakeholders
Special thanks go to the many stakeholders across the globe who reviewed
guideline processes and drafts. All stakeholder comments were reviewed by
the EPUAP-NPUAP Guideline Development Group. Revisions were made
based on these comments. We appreciate the investment of clinicians,
researchers, educators, and manufacturers from all over the world who took
the time to share their expertise and thoughtful critique. The guideline
recommendations are better because of you!
Special thanks go to Timothy J. Gilbert, BA his excellent work in preparing this
document and supporting the work of the Guideline Development Group.
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Executive Summary
Significance
Pressure ulcers are painful, costly, and often preventable complications that
threaten many individuals in hospitals, nursing homes, and home care. They
remain a frequently occurring health care problem throughout the world. A
European pilot survey undertaken by the European Pressure Ulcer Advisory
Panel (EPUAP), which included 5947 patients located in Belgium, Italy,
Portugal, Sweden, and the United Kingdom, found an overall prevalence of
18.1%, although there was some variation between countries (1). In 2001, The
National Pressure Ulcer Advisory Panel (NPUAP) estimated that pressure ulcer
prevalence in American hospitals was 15% and the incidence 7% (2).
More recent national studies fail to demonstrate sustained significant
declines in American hospitals or other health care settings (3, 4). Prevalence
and incidence rates are often higher in unique populations such as those
receiving palliative care in home hospice (5, 6), those with spinal cord injuries
(7), and in critical care units (8). Pressure ulcers represent a major burden of
sickness and reduced quality of life for patients and their carers (9–11).
Increased morbidity and mortality associated with pressure ulcer
development in hospitalized patients is documented in multiple studies (12–
15). Hospital lengths of stay, readmission rates, and hospital charges are
greater in patients who develop pressure ulcers than in those remaining
ulcer-free (12–14, 16). The development of a single pressure ulcer in U.S.
hospitals can increase a patient’s length of stay five-fold and increase hospital
charges by $2,000–11,000 (12). Recent European cost-models to highlight the
cost of illness associated with pressure ulcers have indicated that the total
costs may consume between 1% in the Netherlands (17) and 4% in the United
Kingdom (18) of health care expenditure.
Purpose and Scope
The goal of this guideline is to provide evidence-based recommendations for
the prevention and treatment of pressure ulcers that can be used by health
care professionals throughout the world. The purpose of the prevention
recommendations is to guide evidence-based care to prevent the
development of pressure ulcers. The prevention recommendations will apply
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to all vulnerable individuals of all age groups. The guideline is intended for the
use of health care professionals who are involved in the care of patients and
vulnerable people who are at risk of developing pressure ulcers, whether they
are in a hospital, long-term care, assisted living at home, or any other setting,
and regardless of their diagnosis or other health care needs. It will also help
to guide patients and carers on the range of prevention strategies that are
available.
The purpose of the treatment recommendations is to guide evidence-based
care for patients with existing pressure ulcers. The treatment
recommendations apply to all individuals with pressure ulcers regardless of
setting. The guideline is intended for the use of health care professionals who
are involved in the care of patients with existing pressure ulcers. It will also
guide patients and caregivers. Patients with pressure ulcers are usually at risk
for additional pressure ulcers, therefore the prevention guideline should also
be followed for these individuals.
Guideline Development
The European Pressure Ulcer Advisory Panel (EPUAP) and the American
National Pressure Ulcer Advisory Panel (NPUAP) collaborated to develop
guidelines on the prevention and treatment of pressure ulcers. The EPUAP
took the lead on the pressure ulcer prevention guideline in collaboration with
the NPUAP, and the NPUAP took the lead on the pressure ulcer treatment
guideline in collaboration with the EPUAP. The guidelines were produced by a
multidisciplinary Guideline Development Group (GDG) and several Small
Working Groups (SWGs) consisting of members of both EPUAP and NPUAP.
The GDG determined and monitored the guideline development process. The
entire process of developing the guideline could be followed by stakeholders
on a website (www.pressureulcerguideline.org).
The first step in the guideline development process was identifying the
evidence. The GDG conducted an extensive review of the literature on
pressure ulcer prevention and treatment in several electronic databases using
a sensitive search strategy. All retrieved references were screened by the
GDG on predetermined inclusion criteria. In a second step, the retrieved
evidence was evaluated, and thereafter the full papers were divided
according to topic and sent to the relevant SWGs. The members of the SWGs
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created evidence tables and scored a methodology checklist developed by the
GDG for each study. The level of evidence was noted for each study, using a
classification system adapted from Sackett (19).
The next step was drafting the recommendations. Each SWG formulated
conclusions about the body of available evidence based on the evidence
tables and quality evaluations. In step 4, strength of evidence ratings were
then assigned to recommendations. This rating identifies the strength of
cumulative evidence supporting a recommendation. In the final step, the
SWGs summarized the evidence supporting each statement.
Guideline Recommendations
Guidelines are systematically developed statements to assist practitioner
and patient decisions about appropriate health care for specific clinical
conditions. The recommendations may not be appropriate for use in all
circumstances. The decisions to adopt any particular recommendation must
be made by the health care professional in light of available resources and
the circumstances presented by the individual patient. Nothing contained
in this book is to be considered medical advice for specific cases. This book
and any recommendations herein are intended for educational and
informational purposes only. Generic names of products are provided.
Nothing in this guideline is intended as an endorsement of a specific
product.
Prevention
The prevention guideline comprises seven topics: etiology, risk assessment,
skin assessment, nutrition, positioning, support surfaces, and special
populations: operating room patients.
Etiology
The etiology section is an introductory section to the prevention guideline.
The procedure for the development of this section was different from that
for the other guideline sections. As etiology research is more basic science,
only a few studies were retrieved with the literature search strategy.
Therefore, this section started from the current state of the art and
knowledge on etiology and gives a brief overview consisting of four items:
mechanical load/magnitude and time, tissue reactions at different types of
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mechanical loading, mechanisms that lead to tissue damage and factors
that influence susceptibility.
Risk Assessment
Risk assessment is a central component of clinical practice that aims to
identify susceptible patients in order to tar- get appropriate interventions to
prevent pressure ulcer occurrence. The statements on risk assessment
include risk assessment policy and risk assessment practice. Using a
structured approach to risk assessment to identify vulnerable patients is of
primary importance and includes the use of a risk assessment scale in
combination with a comprehensive skin assessment, the assessment of
activity and mobility and clinical judgment. In this guideline, most
frequently occurring risk factors are described. The main risk factors are
nutritional indicators, factors affecting perfusion and oxygenation, skin
moisture, and increased age. The statements on risk factors were based on
studies using multivariable analysis. However, one must be careful with
interpreting the results of these epidemiological research studies as the
results may depend on which risk factors are included in the multivariable
model.
Risk assessment should be conducted on admission, and repeated as
frequently as required by patient acuity. Reassessment should also be
undertaken if there is any change in patient condition.
Skin Assessment
Skin assessment is important in pressure ulcer prevention because skin
status has been identified as a risk factor for pressure ulcer development.
The skin can also serve as an indicator of early signs of pressure damage.
This section comprises statements on skin assessment and skin care. A
complete skin assessment consisting of assessment for localized heat,
edema, or induration (hardness) should be included in the risk assessment
screening policy. Skin care comprises statements on how to protect the
skin from pressure ulcer development by, for example, not using massage,
not turning the individual onto a body surface still reddened from a previous
episode of pressure loading, and not vigorously rubbing skin at risk for
pressure ulceration.
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Nutrition
Multivariate analysis of epidemiological data indicates that a poor nutritional
status and related factors, such as low body weight and poor oral food intake
are independent risk factors for the development of pressure ulcers. However,
the exact causal relationship between a pressure ulcer and nutrition still
remains unclear.
In this guideline, malnutrition refers to a status of under-nutrition. This
section starts with general recommendations based on the ESPEN (The
European Society for Clinical Nutrition and Metabolism) and the ASPEN
(The American Society for Parenteral and Enteral Nutrition) guidelines and
on literature specific to nutrition, including recommendations on
nutritional screening and assessment.
Specific studies on nutritional interventions to prevent pressure ulcers are
scarce. It is recommended to offer high-protein mixed oral nutritional
supplements and/or tube feeding in addition to the usual diet to individuals
with nutritional risk and pressure ulcer risk because of acute or chronic
diseases or following a surgical intervention.
Repositioning
Repositioning involves a change in position in the lying or seated individual,
with the purpose of relieving or redistributing pressure and enhancing
comfort, undertaken at regular intervals. Repositioning should be
considered in all at-risk individuals and must take into consideration the
condition of the patient and the support surface in use.
The repositioning frequency should be influenced by the individual and the
support surface in use. Repositioning should maintain the individual’s
comfort, dignity, and functional ability. In addition, statements on
repositioning the seated individual, on repositioning documentation, and on
repositioning education and training are provided.
Support Surfaces
Support surfaces are specialized devices for pressure redistribution,
designed for management of tissue loads, microclimate, and/or other
therapeutic functions (e.g., any mattress, integrated bed system, mattress
replacement, mattress overlay, seat cushion, or seat cushion overlay). This
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section starts with some general statements on support surfaces for the
prevention of pressure ulcers.
The recommendations consist of four detailed items: mattress and bed
use, the prevention of heel pressure ulcers, seats and cushions, and other
forms of support surface.
• Mattress and bed use in pressure ulcer prevention. It is
recommended to use a higher specification foam mattress rather
than non-pressure redistributing mattress for all individuals
assessed as at-risk for pressure ulcer development. There is no
evidence of the superiority of one high specification foam mattress
over alternative high specification foam mattresses. Use an active
support surface (overlay or mattress) for patients at higher risk of
pressure ulcer development where frequent manual repositioning
is not possible. Overlay and mattress-replacement alternatingpressure active-support surfaces have a similar efficacy in terms of
pressure ulcer incidence. Do not use small-cell alternatingpressure air mattresses or overlays. Continue to turn and
reposition where possible all individuals at risk of pressure ulcers.
• When using support surfaces to prevent heel pressure ulcers,
ensure that heels are free of the surface of the bed. Heel
protecting devices should elevate the heel completely (off load) in
such a way as to distribute the weight of the leg along the calf
without putting pressure on the Achilles tendon. The knee should be
in slight flexion.
• The section on the use of support surfaces to prevent pressure
ulcers while seated includes statements on the use of a pressure
redistribution seat cushion.
• The recommendations relating to other support surfaces in
pressure ulcer prevention include statements on the use of
sheepskins.
Special Populations: Patients in the Operating Room
As pressure ulcers frequently occur in patients on surgical units or wards,
particular attention should be paid to patients undergoing surgery. This
section includes statements on refining risk assessment of individuals
undergoing surgery, using pressure-redistributing mattresses on the
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operating table, positioning of the patient, and paying attention to pressure
redistribution prior to and after surgery.
Treatment
Recommendations and research were also summarized for a
comprehensive array of topics related to pressure ulcer treatment.
Pressure Ulcer Classification
Pressure ulcer treatment begins with an accurate diagnosis and classification
of pressure ulcers. A validated pressure ulcer classification system should be
used. Professionals should be educated about the appearance of different
types of tissue, differentiating pressure ulcers from other types of wounds
and skin conditions, and special techniques for assessing darkly pigmented
skin. Inter-rater reliability should be confirmed. Pressure ulcers on mucous
membranes should not be classified using existing classification systems.
Assessment and Monitoring of Healing
An initial holistic assessment should be performed on all patients with
pressure ulcers. Reassess the patient and treatment plan if the ulcer fails to
show signs of healing within two weeks. The pressure ulcer should be
assessed at least weekly; specific strategies for assessment are provided.
Simple documentation of pressure ulcer status is not enough. The
professional should continuously monitor progress toward healing,
adjusting treatment plans as needed. Two tools for monitoring pressure
ulcer healing are recommended.
Role of Nutrition in Pressure Ulcer Healing
Nutritional status should be assessed for all individuals with pressure ulcers
initially, with a change in condition, and when the ulcer is not showing signs
of healing. Specific recommendations are provided to address the caloric,
protein, fluid, vitamin, and mineral intake necessary to support healing.
Pain Assessment and Management
Pressure ulcer-related pain is a common complication that is often undertreated. Pain should be evaluated in all patients with pressure ulcers,
including infants, children, and cognitively impaired adults. Specific
recommendations are provided for preventing pain, managing general pain,
reducing debridement pain, and managing chronic pain.
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Support Surfaces for Treatment of Pressure Ulcers
Support surfaces and repositioning strategies are part of a total program
of pressure ulcer prevention and treatment. Support surfaces facilitate
pressure redistribution through immersion, envelopment, and/or by
shifting the contact area from one part of the individual’s body to another.
There is also a growing appreciation of the role of microclimate control in
supporting pressure ulcer healing. While professionals caring for an
individual with pressure ulcers may desire clear-cut protocols on support
surface selection, the strength of current evidence does not sup- port
prescriptive recommendations. Available evidence on the effects of various
support surfaces on pressure ulcer healing is presented. This evidence
should be used to help make clinical decisions that best match the needs
of the patient with the characteristics of the support surface. The special
needs of critically ill, spinal cord injured, and bariatric patients are
addressed.
Wound Bed Preparation: Cleansing, Debridement & Dressings
Overarching principles of wound bed preparation and the special
challenges posed by biofilms are presented. Recommendations and
research evidence are provided for the critical approaches necessary to
prepare the wound bed for healing: cleansing, debridement, and selection of
dressings. Saline or potable water may be used to cleanse most pressure
ulcers; solutions with surfactants and/or antimicrobials may be used for
pressure ulcers with debris or suspected/confirmed infection. Cleansing the
peri-wound has been shown to decreases bacterial counts in the wound.
Debridement methods, indications, and contraindications are discussed in
relation to available evidence.
Over the past decade, there has been substantial research and
development in the area of dressings. Recommendations and supporting
evidence are provided for the use of myriad dressings, including
hydrocolloid, transparent film, hydrogel, alginate, foam, polymeric
membrane, silver-impregnated, honey-impregnated, cadexomer iodineimpregnated, gauze, silicone-coated, collagen matrix, and composite
dressings for the treatment of pressure ulcers.
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Assessment and Treatment of Infection
Infected pressure ulcers do not heal. Prevention, early diagnosis, and
effective treatment of infection are critical components of pressure ulcer
healing. Recommendations focus on early identification of patients at high
risk for pressure ulcer infection and early recognition of critical colonization
and local infection using more subtle clinical indicators, such as new or
increasing ulcer pain, pocketing, friable granulation tissue, and increased
drainage. Quantitative tissue culture is the gold standard for diagnosing
infection; however, the Levine quantitative swab culture technique has
demonstrated reasonable sensitivity and specificity. Management of
pressure ulcer infection focuses on optimizing the host response,
preventing contamination, and reducing the bacterial load. The special
challenges posed by biofilms are discussed. A variety of topical
antimicrobial agents (including properly selected and diluted antiseptics,
silver, medical-grade honey, and cadexomer iodine) are receiving cautious
consideration in an era of growing antibiotic resistance. Systemic antibiotics
are usually reserved for systemic infections, such as cellulitis, fasciitis,
osteomyelitis, bacteremia, and sepsis.
Biophysical Agents in Pressure Ulcer Management
Different forms of energy (e.g., mechanical, electrical, magnetic, light) have
been used in the management of pressure ulcers. Properly designed and
conducted studies of pressure ulcer healing in human subjects provide
sufficient evidence to recommend electrical stimulation, and negative
pressure wound therapy under carefully selected circumstances. Several
additional modalities are considered based on indirect evidence and/or
expert opinion. These include pulsed electromagnetic fields, ultraviolet light,
ultrasound, whirlpool, and pulsed lavage with suction. There is currently
insufficient evidence to recommend infrared therapy, laser therapy,
hyperbaric oxygen therapy, and topical oxygen therapy as biophysical agents
for pressure ulcer treatment. There was also insufficient evidence to support
the use of biological dressings and growth factors, although these treatments
have been effective in diabetic (neurotrophic) foot ulcers.
Surgery for Pressure Ulcers
Current research examining the outcomes of surgical treatments for pressure
ulcers is examined. Rather than focus on a specific surgical technique, the
recommendations in this sections focus on preoperative preparation,
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Treatment Technical Report
intra- operative care, post-operative care, and rehabilitation designed to
support a long-term successful outcome.
Pressure Ulcer Management of Individuals Receiving Palliative Care
All aspects of pressure ulcer care are re-examined through the lens of
patients receiving palliative care. Principles of palliative care and research
on pressure ulcer care are synthesized to provide guidance focused on
respect for the individual’s wishes, maintaining comfort, and optimizing
quality of life. Specific recommendations address repositioning, pain
management, and exudate-odor control.
References
(1) Vanderwee K, Clark M, Dealey C, Gunningberg L, Defloor T. Pressure ulcer
prevalence in Europe: a pilot study. J Eval Clin Pract. 2007;13(2):227-32.
(2) National Pressure Ulcer Advisory Panel. Pressure ulcers in America: prevalence,
incidence, and implications for the future. Cuddigan J, Ayello E, Sussman C, editors.
Reston, VA: NPUAP; 2001.
(3) Russo CA, Elixhauser A. Hospitalizations related to pressure sores, 2003.
Healthcare Cost and Utilization Project. Rockville, MD: Agency for Healthcare
Research and Quality; 2007.
(4) VanGilder C, MacFarlane GD, Meyer S. Results of nine international pressure
ulcer prevalence surveys: 1989 to 2005. Ostomy Wound Manage. 2008;54(2):40-54.
(5) Reifsnyder J, Magee HS. Development of pressure ulcers in patients receiving
home hospice care. Wounds. 2005;17(4):74-9.
(6) Tippett AW. Wounds at the end of life. Wounds. 2005;17(4):91-8.
(7) Cardenas DD, Hoffman JM, Kirshblum S, McKinley W. Etiology and incidence of rehospitalization after traumatic spinal cord injury: a multicenter analysis. Arch Phys
Med Rehabil. 2004;85(11):1757-63.
(8) Shahin ESM, Dassen T, Halfens RJG. Pressure ulcer prevalence and incidence
in intensive care patients: a literature review. Nursing In Critical Care.
2008;13(2):71-9.
(9) Franks PJ, Moffatt CJ, Ellison DA, Connolly M, Fielden S, Groarke L, et al. Quality
of life in venous ulceration: A randomized trial of two bandage systems. Phlebology.
1999;14:95-9.
(10) Hopkins A, Dealey C, Bale S, Defloor T, Worboys F. Patient stories of living
with a pressure ulcer. J Adv Nurs.2006;56(4):345-53.
(11) Nixon J, Nelson EA, Cranny G, Iglesias CP, Hawkins K, Cullum NA, et al. Pressure
relieving support surfaces: a randomised evaluation. Health Technol Assess.
2006;10(22):iii-x, 1.
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Treatment Technical Report
(12) Allman RM, Goode PS, Burst N, Bartolucci AA, Thomas DR. Pressure ulcers,
hospital complications, and disease severity: impact on hospital costs and length of
stay. Adv Wound Care. 1999;12(1):22-30.
(13) Allman RM, Laprade CA, Noel LB, Walker JM, Moorer CA, Dear MR, et al.
Pressure sores among hospitalized patients. Ann Intern Med. 1986;105(3):337-42.
(14) Ducker A. Pressure ulcers: assessment, prevention, and compliance. Case
Manager. 2002;13(4):61-4.
(15) Kumar RN, Gupchup GV, Dodd MA, Shah B, Iskedjian M, Einarson TR, et al.
Direct health care costs of 4 common skin ulcers in New Mexico Medicaid fee-forservice patients. Adv Skin Wound Care. 2004;17(3):143-9.
(16) Stausberg J, Kroger K, Maier I, Schneider H, Niebel W. Pressure ulcers in
secondary care: incidence, prevalence, and relevance. Adv Skin Wound Care.
2005;18(3):140-5.
(17) Severens JL, Habraken JM, Duivenvoorden S, Frederiks CMA. The cost of illness
of pressure ulcers in The Netherlands. Adv Skin Wound Care. 2002;15(2):72-7.
(18) Bennett G, Dealey C, Posnett J. The cost of pressure ulcers in the UK. Age Ageing.
2004;33(3):230-5.
(19) Sackett DL. Evidence-based medicine: how to practice and teach EBM New York,
NY: Churchill Livingstone; 1997.
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Treatment Technical Report
Methodology for Guideline Development
Purpose and Scope
The overall purpose of this international collaboration was to develop
evidence-based recommendations for the prevention and treatment of
pressure ulcers that could be used by health care professionals throughout
the world. A joint Guideline Development Group with representatives from
both the NPUAP and the EPUAP planned the guideline development
process and reviewed all the documentation. However, to simplify logistics,
the EPUAP took the lead on the pressure ulcer prevention
recommendations, and the NPUAP took the lead on the pressure ulcer
treatment recommendations.
The purpose of the prevention recommendations is to guide evidence-based
care to prevent the development of pressure ulcers. The prevention
recommendations will apply to all vulnerable individuals of all age groups.
The guideline is intended for the use of health care professionals who are
involved in the care of patients and vulnerable people who are at risk of
developing pressure ulcers, whether they are in a hospital, long-term care,
assisted living at home, or any other setting and regardless of their diagnosis
or health care needs. It will also help to guide patients and carers on the
range of prevention strategies that are available.
The purpose of the treatment recommendations is to guide evidence-based
care for patients with existing pressure ulcers. The treatment
recommendations apply to all individuals with pressure ulcers regardless of
setting. The guideline is intended for the use of health care professionals
who are involved in the care of patients with existing pressure ulcers. It will
also guide patients and caregivers. Patients with pressure ulcers are usually
at risk for additional pressure ulcers; therefore, the prevention guideline
should also be followed for these individuals. Based on the results of a gap
analysis of existing pressure ulcer treatment guidelines, recommendations
regarding the unique needs of several special populations have been
addressed where evidence exists. These include spinal cord injured
individuals, infants and children, critically ill patients, bariatric patients, and
patients requesting palliative care.
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Treatment Technical Report
A rigorous and explicit methodology was agreed upon at the onset of this
collaboration and rigorously adhered to throughout the development of
the guideline. This methodology for evidence-based guideline development
is described below.
Participants
Guideline Development Group. The EPUAP and NPUAP nominated six
representatives each to form the Guideline Development Group (GDG).
The EPUAP and NPUAP each had six votes during joint deliberations, with
the majority deciding. Examination of the evidence and consensus building
preceded all votes. Minority opinions were represented in meeting
minutes.
The GDG determined and monitored the guideline development process. As
an initial step, the GDG reviewed the literature on guideline development
methodologies and internationally developed criteria evaluating the quality of
guidelines. The group agreed upon a methodology that was sufficiently clear
to be reliably and consistently followed by the small working groups of
international experts reviewing the evidence and drafting the
recommendations, yet rigorous in meeting quality standards. This guideline
development methodology is described in detail below.
GDG members and others involved in the actual development of the
guideline were screened for potential conflicts of interest. Representatives of
industry were excluded from developmental groups but were invited to
participate as stakeholders.
Small Working Groups. The guideline content was broken down into topics,
and Small Working Groups (SWGs) were formed to review the evidence
available for each topic. Guideline development was an iterative process,
with GDG and SWG members maintaining close communication. Evidence
summaries and draft recommendations developed by the SWGs were
reviewed by the GDG for (1) comprehensiveness and accuracy of literature
reviews, (2) methodological rigor in evidence analysis and application to
clinical practice, and (3) clarity and appropriate- ness of recommendations
for an international audience.
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Treatment Technical Report
Stakeholders. The entire process of developing the guideline could be
followed by stakeholders on a website,
(http://www.pressureulcerguideline.org). A stakeholder is someone who has
interest in pressure ulcers and wishes to contribute to the guideline by
reading the methodology, search strategies, references under
consideration, and draft recommendations, ensuring that all relevant
evidence had been included and commenting on the draft guide- line within
the timeframe allowed.
A total of 903 individuals and 146 societies/ organizations registered as
stakeholders. Sixty-three countries on six continents were represented in
this group. Anyone could become a stakeholder, either as an individual or as
a representative for a society/organization. All members of the EPUAP and
the NPUAP were encouraged to sign up as stakeholders and participate in
this process. Individuals with a history of pressure ulcers were recruited to
review the guideline from a consumer perspective. When new
recommendations were posted on the website, registered stakeholders
were notified by electronic mail. The GDG reviewed all stakeholder
comments and any additional evidence recommended by stakeholders
before approving final recommendations. Stakeholders identified additional
evidence that was incorporated into the guideline and provided an
international perspective for translating evidence into practice
recommendations.
Methods
The steps of the guideline development process are delineated below. For
simplicity and clarity, the process is described as linear and sequential;
however, the actual process was iterative, with multiple drafts developed and
progressively improved based on ongoing communication among GDG
members, SWG members, and stakeholders.
Step 1: Identifying the Evidence
Databases. To identify the scientific literature on pressure ulcer prevention
and treatment, several electronic data- bases were consulted, such as
PubMed, CINAHL, EMBASE, The Cochrane Database of Systematic Reviews,
The Cochrane Central Register of Controlled Trials, Health Technology
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Treatment Technical Report
Assessment, and AMED databases. Inclusive dates were January 1998
through January 2008.
Search strategies. A sensitive search strategy was developed by the GDG;
search terms and strategies have been published on the guideline website
for stakeholder review and comment. Full lists of articles identified by
these search strategies were also available for stakeholder review. SWGs also
conducted additional focused searches to ensure the full depth and breadth
of their topic area had been covered.
Inclusion criteria. All references retrieved by the electronic literature search
were screened by the GDG based on the following inclusion criteria. The
articles must have been primarily focused on pressure ulcer prevention,
risk assessment, and treatment in human subjects. The articles must have
been published in a peer reviewed journal. An abstract must have been
available. The studies should have used one of the following designs:
randomised con- trolled trials, controlled clinical trials, quasi-experimental
studies, cohort studies, cross-sectional studies, survey studies, prevalence
or incidence studies, case-control studies, and case series. At least 10
subjects must have been included in any case series. Systematic reviews or
meta-analyses were included if they used the Cochrane methodology. SWG
reviewers were asked to refer to the original articles cited in systematic
reviews and meta- analyses. Studies using established qualitative
methodologies were also considered as appropriate to the research
question. There was no restriction on the basis of language of a study.
Economic evaluations were excluded because of limitations in existing
literature and differences in health care systems across countries. Studies not
initially identified by bibliographic searches yet meeting these criteria were
included when listed in reference lists of identified articles and
recommended by stakeholders.
Direct vs. indirect evidence. Studies of pressure ulcers in humans were
considered “direct evidence” and were required to support an A or B
strength-of-evidence rating. When studies of pressure ulcers in humans
were not available, studies in normal human subjects, human subjects
with other types of chronic wounds, or laboratory studies using animals
could be used to support recommendations with a C strength-of-evidence
rating. The majority of the recommendations with a C strength-of-evidence
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Treatment Technical Report
rating are supported by indirect research or previous guidelines, and do
not rely solely on expert opinion.
Step 2: Evaluating the Evidence
Data abstraction. The full papers of selected references were obtained and
divided according to topic and then sent to the relevant SWGs. The SWGs
consist of trustees and members of the EPUAP and NPUAP. The members of
the SWGs created evidence tables and scored a methodology checklist
developed by the GDG for each study. The template of the evidence table
consisted of reference of the study, type of study, sample, intervention(s),
out- come measures and length of follow-up, results, and limitations.
Methodological quality. The methodological quality of each study was
assessed by two reviewers using method- ology checklists that were
developed by the GDG, based on the Scottish Intercollegiate Guidelines
Network(1). These checklists helped the reviewers to judge the quality of the
study. Evaluation of study quality concentrated on the internal and external
validity of the studies. The following quality criteria were considered: internal
validity of the study, clear and appropriate research question(s), selection
of subjects, allocation, baseline comparability, out- comes, blinding,
confounding factors, statistical analysis, overall assessment of the study, and
bias. There were different types of methodology checklists based on the
study design: cross-sectional/survey/prevalence studies, case- control
studies, cohort studies, randomized controlled trials, quasi-experimental
study, diagnostic studies, and systematic reviews/reviews/meta-analyses. All
papers were evaluated by two members of the SWGs. The GDG completed a
quality check of a random sample of 10% of the completed evidence tables.
Level of evidence. The level of evidence was noted for each study, using a
classification system adapted from Sackett(2). Sackett and his colleagues
have developed more sophisticated and complex classification systems(3);
however, the elegant simplicity of their early work provided greater
consistency when used with a large international group of reviewers.
Table 1. Level of Evidence for Individual Studies
1 Large randomized trial(s) with clear-cut results (and low risk of error)
2 Small randomized trial(s) with uncertain results (and moderate to high
risk of error)
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Treatment Technical Report
3
4
5
Non randomized trial(s) with concurrent or contemporaneous controls
Non randomized trial(s) with historical controls
Case series with no controls. Specify number of subjects.
Step 3: Drafting Recommendations
Each SWG formulated conclusions about the body of available evidence
based on the evidence tables and quality evaluations. Evidence tables from
previous guidelines were also made available to the treatment SWGs to
ensure the full body of scientific literature was reviewed. A first draft of
recommendations was developed by the respective SWGs. The GDG
reviewed the draft recommendations, making revisions as necessary.
To ensure uniformity and internal consistency in the final guideline, the
GDG provided the following guidance. Each recommendation should start
with an action verb and be a simple, short, direct, declarative statement,
free of jargon. Multiple complex recommendations were broken down into
a series of smaller, discrete recommendations. Authors were advised to
start with broad, directive statements, followed by subsequent statements
with more detail (how, when, how often). Spelling was determined based
on the conventions of American English. The GDG reviewed all
recommendations to ensure the wording of the recommendations
accurately translated available research into best practice while being
sensitive to the many different individual cultures and professional standards
represented among the international audience for these guidelines.
The term “individual” was used to describe the patient, client, resident, or
person with a pressure ulcer or at risk for a pressure ulcer. The term
“professional” was used when referring to the health care professional
providing professional health care services to the individual. The disciplines
of professionals performing a given service may vary from country to
country based on the laws and regulations governing health care providers.
Products available in one country may not be available in another. Individual
circumstances vary; the professional and individual should use these
guidelines to meet the goals and wishes of the individual within the context
of his or her unique circumstances. In all cases, the recommendations
should be used to guide the professional in providing care to the individual
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Treatment Technical Report
with a pressure ulcer or at risk for developing a pressure ulcer; this
document is not intended as a standard or mandate for care.
Step 4: Assigning Strength of Evidence Ratings
Strength of evidence ratings were then assigned to recommendations. This
rating identifies the strength of cumulative evidence supporting a
recommendation. The strength of evidence supporting the recommendation
is not the same as the strength of the recommendation. For example, there
are no randomized controlled trials in humans with pressure ulcers that
evaluate debridement vs. no debridement. Therefore, this recommendation
would have a relatively low strength of evidence supporting the
recommendation, yet the recommendation is strongly recommended in
many clinical situations based on evidence from studies of other types of
chronic wounds, proof of principle from basic science research, and/or
expert opinion.
Table 2. Strength of Evidence Rating for Each Recommendation
A
The recommendation is supported by direct scientific
evidence from properly designed and implemented
controlled trials on pressure ulcers in humans (or humans
at-risk for pressure ulcers), providing statistical results that
consistently support the guideline statement (Level 1
studies required).
B
The recommendation is supported by direct scientific
evidence from properly designed and implemented clinical
series on pressure ulcers in humans (or humans at-risk for
pressure ulcers), providing statistical results that
consistently support the recommendation. (Level 2, 3, 4, 5
studies)
C
The recommendation is supported by indirect evidence (e.g.,
studies in normal human subjects, humans with other types
of chronic wounds, animal models) and/or expert opinion.
A strength of evidence rating of A requires Level 1 studies of humans with
pressure ulcers or at risk for pressure ulcers. This rating is consistent with
recommendations derived using the Cochrane methodology. A strength of
evidence of B requires Level 2, 3, 4, and/or 5 studies in these populations.
Recommendations supported by A and B strength of evidence ratings were
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Treatment Technical Report
developed first. This strategy provided recommendations with very direct
evidentiary support, but the guideline lacked the breadth and depth of
guidance necessary to provide care.
Previous guidelines have filled this “evidence gap” with “expert opinion” and
given a strength of evidence of C. In developing this guideline, evidence gaps
were explicitly identified. Systematic literature reviews were then conducted to identify indirect evidence from studies of normal subjects,
studies with intermediate or surrogate out- comes, studies of humans
with other types of chronic wounds, and animal studies. For many
recommendations, indirect evidence has been identified to support C
strength of evidence ratings. In the absence of indirect evidence, consensus
from previous guidelines often supports C strength of evidence ratings,
providing a broader base of expert opinion than that available in the SWGs
and GDG. All recommendations, including those supported solely by expert
opinion have been reviewed by stakeholders.
Step 5: Summarizing Supporting Evidence
The SWGs summarized the evidence supporting each recommendation. All
recommendations with a strength of evidence rating of A or B required an
explicit summary of one or more studies of human subjects with pressure
ulcers or at risk for pressure ulcer development. The level of evidence for
each study is also identified.
The summary statements for recommendations with a strength of evidence
of C clarify whether the recommendation was supported by (1) indirect
evidence from studies of normal subjects, studies with intermediate or
surrogate outcomes, studies of humans with other types of chronic
wounds, and animal studies or other basic bench research, (2) expert
opinion supported by previous evidence-based guidelines, and/or (3) the
expert opinion of the SWG and GDG members as reviewed by international
stakeholders. Evidence gaps identified in these summary statements serve
as an agenda for future research efforts.
Conclusion
The EPUAP and NPUAP Guideline Development Group is pleased to present
the EPUAP-NPUAP Pressure Ulcer Prevention and Treatment Guideline. The
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Treatment Technical Report
Clinical Practice Guideline version provides evidence-based
recommendations and brief summaries of the evidence and/or
rationale supporting the recommendations. The Quick Reference Guide
version provides basic recommendations only; it has been translated into
several languages other than English. Educational materials and consumer
guides will be developed in multiple languages to meet the needs of
different populations, in different settings, and in different cultures.
Technical Reports for both prevention and treatment provide evidence table
summarizing articles meeting inclusion criteria.
References
(1) Critical Appraisal: Notes and Checklists. Edinburgh: Scottish Intercollegiate
Guidelines Network; [cited September 24, 2009]; Available from: http://
www.sign.ac.uk /methodology/ checklists.html.
(2) Sackett DL. Rules of evidence and clinical recommendations on the use of
antithrombotic agents. Chest. 1989;95(2 Suppl):2S-4s.
(3) Straus SE, Richardson WS, Glasziou P, Haynes RB. Evidence-based medicine: How
to practice and teach EBM. Third ed. Toronto: Elsevier Churchill Livingstone; 2005.
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Treatment Technical Report
NPUAP-EPUAP Pressure Ulcer Classification System
As part of the guideline development process, the NPUAP and EPUAP
developed a common international definition and classification system for
pressure ulcers. Over the past several years, members of the two
organizations have had ongoing discussions about the many similarities
between the NPUAP and EPUAP pressure ulcer grading/staging systems. As
we release an international pressure ulcer prevention and treatment
guideline, we consider this the ideal time to develop a common
classification system that can be used by the international community.
Staging/grading implies a progression from I to III or IV, when that is not
always the case. We attempted to find a common word to describe the
stage or grade and could not do so. “Category” was suggested as a neutral
term to replace “stage” or “grade.” Although foreign to those accustomed
to other terms, “category” has the advantage of being a non-hierarchical
designation, allowing us to free ourselves from the mistaken notions of
“progressing from I to IV” and “healing from IV to I.”
We recognize that there is a familiarity to the words “stage” and “grade,” and
therefore we are proposing to use whatever word (e.g., stage, grade, or
category) is most clear and understood. However, we see that the most
significant benefit from this collaboration is that the actual definitions of
pressure ulcers and the levels of skin-tissue injury are the same, even
though one group may label the pressure ulcer as a “stage” or “grade” or
“category.”
We have agreed upon four levels of injury. Recognizing that the terms,
”unclassified/unstageable” and ”deep tissue injury” are generally graded as
“IV” in Europe, NPUAP has agreed to put them separately in the text in the
guideline. This difference will remain an issue when comparing crosscountry data.
Common Definition of Pressure Ulcers
A pressure ulcer is localized injury to the skin and/or underlying tissue,
usually over a bony prominence, as a result of pressure or pressure in
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Treatment Technical Report
combination with shear. A number of contributing or confounding factors
are also associated with pressure ulcers; the significance of these factors
has yet to be elucidated.
NPUAP/EPUAP Pressure Ulcer Classification System
Category/Stage I: Non-blanchable redness of intact skin
Intact skin with non-blanchable erythema of a localized area, usually over a
bony prominence. Discoloration of the skin, warmth, edema, hardness, or
pain may also be present. Darkly pigmented skin may not have visible
blanching. Further description: The area may be more painful, firmer or
softer, or warmer or cooler than adjacent tissue. Category/Stage I may be
difficult to detect in individuals with dark skin tones. This may indicate an
at-risk individual.
Category/Stage II: Partial Thickness skin loss or blister
Partial thickness loss of dermis presenting as a shallow open ulcer with a
red/pink wound bed, without slough. It may also present as an intact or
open/ruptured serum-filled or sero-sanginous-filled blister.
Further description: Presents as a shiny or dry shallow ulcer without slough
or bruising. This category/stage should not be used to describe skin tears,
tape burns, incontinence-associated dermatitis, maceration, or excoriation.
Category/Stage III: Full thickness skin loss (fat visible)
Full thickness tissue loss. Subcutaneous fat may be visible, but bone,
tendon, or muscle are not exposed. Some slough may be present. It may
include undermining and tunneling.
Further description: The depth of a Category/Stage III pressure ulcer varies
by anatomical location. The bridge of the nose, ear, occiput, and malleolus
do not have (adipose) subcutaneous tissue, and Category/Stage III ulcers can
be shallow. In contrast, areas of significant adiposity can develop extremely
deep Category/Stage III pressure ulcers. Bone/tendon is not visible or
directly palpable.
Category/Stage IV: Full thickness tissue loss (muscle/bone visible)
Full thickness tissue loss with exposed bone, tendon, or muscle. Slough or
eschar may be present. It often includes undermining and tunneling.
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Treatment Technical Report
Further description: The depth of a Category/Stage IV pressure ulcer varies
by anatomical location. The bridge of the nose, ear, occiput, and malleolus
do not have (adipose) subcutaneous tissue, and these ulcers can be
shallow. Category/Stage IV ulcers can extend into muscle and/or supporting
structures (e.g., fascia, tendon, or joint capsule), making osteomyelitis or
osteitis likely to occur. Exposed bone/muscle is visible or directly palpable.
Additional Categories for the USA
Unstageable/unclassified: Full thickness skin or tissue loss – depth
unknown
Full thickness tissue loss in which actual depth of the ulcer is completely
obscured by slough (yellow, tan, gray, green, or brown) and/or eschar (tan,
brown, or black) in the wound bed.
Further description: Until enough slough and/or eschar is removed to
expose the base of the wound, the true depth cannot be determined, but
it will be either a Category/Stage III or IV. Stable (dry, adherent, intact,
without erythema or fluctuance) eschar on the heels serves as “the body’s
natural (biological) cover” and should not be removed.
Suspected Deep Tissue Injury – depth unknown
Purple or maroon localized area of discolored, intact skin or blood-filled
blister due to damage of underlying soft tissue from pressure and/or shear.
Further description: The area may be preceded by tissue that is painful,
firm, mushy, boggy, or warmer or cooler than adjacent tissue. Deep tissue
injury may be difficult to detect in individuals with dark skin tones. Evolution
may include a thin blister over a dark wound bed. The wound may further
evolve and become covered by thin eschar. Evolution may be rapid exposing
additional layers of tissue even with treatment.
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Treatment Technical Report
Table 1. Classification of Pressure Ulcers
References
Allcock N, Wharrad H,
Nicolson A. Interpretation
of pressure-sore
prevalence. J Adv Nurs.
1994;20(1):37-45.
Beeckman D, Schoonhoven
L, Boucqué H, Van Maele
G, Defloor T. Pressure
ulcers: e-learning to
improve classification by
nurses and nursing
students. J Clin Nurs.
2008;17(13):1697-707.
Type of Study
Sample
Intervention(s)
Study data were
collected by the
infection control link
nurses (ICLN) who all
attended training
sessions to inform
them of the aims and
methods of the study
as well as receiving
education on the
grading system
Random assignment
of convenience
sample to e-learning
of the EPUAP grading
system for pressure
ulcers. Control group
received instruction
in the classroom
803 patients on wards
day of study
The training involved a
revision of the structure of
the skin followed by a
discussion of the grading
system and an opportunity
to practice using the grading
system using color slides of
sores collected prior to the
study
Nursing students
Qualified nurses from 7
hospitals, 7 nursing
homes, 1 home care
agency and 5 schools of
nursing
Both groups received similar
illustrations, tests and
instruction
Both groups tested on 20
photographs of normal skin
(1), blanchable erythema
(1), stage I (3), II (3), III (3),
IV (3), moisture lesions (3)
and combined ulcers (3)
(both moisture and
pressure)
No difference in pretest between
groups
Classified 20 photographs of
normal skin (1), blanchable
erythema (1), stage I (3), II
(3), III (3), IV (3), moisture
lesions (3) and combined
ulcers (3) (both moisture
and pressure)
Pressure ulcers were often classified
erroneously and only a minority of
nurses reached a substantial level of
agreement: 33% reached moderate
agreement and only 5% reached
high agreement with known grade
or skin lesion. Grade 3 lesions were
regularly classified as grade 2. Nonblanchable erythema was frequently
assessed incorrectly as blanchable
erythema. Furthermore, the
differential diagnosis between
moisture lesions and pressure ulcers
appeared to be complicated
In the pre-test only one (1.9%)
respondent fell in the group which
achieved between 16-20 (80%)
correct answers and the number in
this group rose to four (7.7%)
respondents in the post-test. The
Beeckman D, Schoonhoven
L, Fletcher J, Furtado Kt,
Gunningberg L, Heyman H,
et al. EPUAP classification
system for pressure ulcers:
European reliability study.
J Adv Nurs.
2007;60(6):682-91.
Survey of 1452
nurses from 5
European countries
familiar with EPUAP
PrU classification
system
Briggs S-L. How accurate
are RGNs in grading
pressure ulcers? Br J Nurs.
2006;15(22):1230-4.
Describe the
accuracy of
registered general
nurses on pressure
ulcer grades using
EPUAP grading
N = 52
32
Outcome Measures &
Length of Follow-up
It was not possible to assess the
accuracy of pressure-sore
identification due to the resources
available The reliability of the ICLNs
pressure sore grading was estimated
using a series of six pictures not
previously seen by the ICLN
Self-assessment of expertise of
identifying ulcers
Results
Limitations
This showed that the distinction
between grades 1 and 2, 3 and
4, and 5 and 6 were difficult The
number correct for each grade was
49%, 47%, 46%, 32%, 36% and 42%
for grades 1-6 respectively If the
grades are combined into three
groups the grading of sores was
much more accurate, grade1 & 2
98% correct, grade 3 & 4 68%
correct and grade 5 & 6 79% correct
Reliability improved with training
but was not perfect, problems
distinguishing stages and IAD from
pressure ulcers
E-learning and classroom learning
led to same outcomes
This suggests that the
grading scheme used may
have had too many
categories to be reliable,
although the difficulties of
grading from a
photograph, due to the
difficulty in judging depth
and other factors, needs
to be taken into account
Treatment Technical Report
References
Type of Study
Sample
Intervention(s)
7 researchers, 20 staff
members and 17
pressure ulcer nurses
Photographs were shown to
the second group and then
differences were measured
system
What was the effect
of education on the
accuracy?
Defloor T, Schoonhoven L.
Inter-rater reliability of the
EPUAP pressure ulcer
classification system using
photographs. J Clin Nurs.
2004;13(8):952-9.
Defloor T, Schoonhoven L,
Vanderwee K, Weststrate
J, Myny D. Reliability of the
European Pressure Ulcer
Advisory Panel
classification system. J Adv
Nurs. 2006;54(2):189-98.
Development and
validity testing of a
series of
photographs of
pressure ulcers and
moisture lesions
using the EPUAP to
establish a "gold
standard" for
accuracy of diagnosis
examine the
interrater and
intra-rater reliability
of classifying
pressure ulcers
according to the
EPUAP classification
system when using
photographs
of pressure ulcers
and incontinence
lesions
Outcome Measures &
Length of Follow-up
biggest increase was in the group
that scored between 11-15 (55% to
75%) correct answers; this group
rose from eight (15.3%) in the pretest to 29 (55.7%) in the post-test.
For those who scored between 6
and 11) correct answers, this group
reduced from 23 (44.2%) in the pretest to 18 (34.6%) in the post-test.
The results of the study indicated
the level of accuracy of pressure
ulcer grading was poor in the pretest but markedly improved in the
post-test.
Deviations in expert scores occurred
in 5.9% of the cases, but 33.3% of
the differences was only one grade
of difference from the gold
standard.
In 3.2% of the cases the deviation is
more than two grades and in 7.3%
of the cases the lesion is classified as
an incontinence lesion. Conclusion
was that photographs were accurate
and could be used to measure
accuracy of pressure ulcer grading.
Phase 1: 65 photos
were presented in a
random order to 473
nurses who were
participating at a
Congress for Wound
Care in Belgium, the
Netherlands and
Finland.
Phase 2: Eighty-six
nurses from a university
hospital in Belgium
participated in the
A set of 56 photographs of
normal skin, blanchable
erythema, pressure ulcers
and incontinence lesions
was used.
If erythema was visible on a
photograph, a second
photograph was also
shown. On this second
photograph a transparent
pressure disk was pressed
onto the erythema so that
the extent to which the
33
An inclusion of ‘‘unclear’’ in the
calculation will artificially raise the
level of agreement
for difficult cases.
The multi-rater Kappa for the 473
nurses was 0. 37 (P < 0.001). If only
the pressure ulcer photos (N = 37)
were considered, the average Kappa
and the weighted Kappas varied
between 0.41 and 0.50. The average
percentage agreement was 55.6%
and 15.7% of the photos were
scored one grade too high or too
low.
The average Kappa did not differ
statistically significantly between
the nurses who received training on
Results
Limitations
Treatment Technical Report
References
Type of Study
Gajewski BJ, Hart S,
Bergquist-Beringer S,
Dunton N. Inter-rater
reliability of pressure ulcer
staging: ordinal probit
Bayesian hierarchical
model that allows for
uncertain rater response.
Stat Med.
2007;26(25):4602-18.
Data from 20
hospitals. Hospitals
deviated from our
specification of n =15
PrUs and p =6 raters
Hart S, Bergquist S,
Gajewski B, Dunton N.
Reliability testing of the
National Database of
Nursing Quality Indicators
pressure ulcer indicator. J
Nurs Care Qual. 2006;21(3
(Print)):256.
256 individuals at 48
randomly sampled
National Database of
Nursing Quality
Indicators (NDNQI)
member hospitals.
Approximately 54%
(n = 26) of the
participating
hospitals were
academic medical
Sample
Intervention(s)
second phase. The
sequential intra-rater
reliability was evaluated
by presenting the same
56 photos twice with an
interval of 1 month. On
both occasions the
photographs were
presented in a different
random order.
erythema was blanchable
was visible. The
photographs were
presented once and the
nurses were asked to
classify the photographs as
normal skin, blanchable
erythema, non-blanchable
erythema (grade 1
pressure ulcer), blister
(grade 2 pressure ulcer),
superficial pressure ulcer
(grade 3), deep pressure
ulcer (grade 4) or
incontinence lesion. Also
the option ‘do not know’
was given.
At the outset the definitions
of grades of pressure ulcers,
as categorized by the
EPUAP, were presented to
the participants in a
standardized way.
To construct a model to
estimate the reliability
of rating PrUs from
patients in NDNQI
hospitals. Stages I to IV
are ordinal and
unstageable, because it
combines III and IV (and
in this case DTI) does
not fit this numeric
relationship
Part 1 of the test asked
participants to identify
whether the wound was
a pressure, venous,
arterial, or diabetic foot
ulcer.
For part 2, individual
participants were asked
to stage the pressure
ulcer in each of the
17 photographs or to
A 3-part criterionreferenced test was created
in collaboration with
experts in wound care and
instrument design. Highquality digital pictures of
ulcerous wounds were used
in this study. Nineteen of
the 25 pictures were
obtained from and used
with permission from the
34
Outcome Measures &
Length of Follow-up
pressure ulcers and those who did
not. P values varied between 0.13
and 0.63.
Grade 1 was the most frequently
wrongly classified grade (54.5%;
3091/5676 observations). In 7.9% of
the observations nonblanchable
erythema was confused with
blanchable erythema, and in 19.6%
of cases with incontinence lesions.
The incontinence lesions were also
frequently wrongly assessed
(44.3%; 1676/3784). In 20.6% of the
observations they were assessed as
superficial pressure ulcer (grade 3),
in 4.2% as blister (grade 2) and in
6.3% as deep pressure ulcer (grade
4).
An inclusion of ‘‘unclear’’ in the
calculation will artificially raise the
level of agreement for difficult
cases.
Results
Wide variation in reporting
unstageable PrU in hospitals
Classified DTI as unstageable
Most raters correctly identified
pressure ulcers from photographs of
ulcerous wounds, but frequently
misclassified the type of nonpressure ulcer wound. Variations in
K agreement were found between
certified and noncertified nurses.
Wound, continence, and/or ostomy
care certified nurses had higher K
values (/c = 0.66, SD = 0.18) than
noncertified nurses (K = 0.54,
Limitations
Treatment Technical Report
References
Type of Study
Sample
Intervention(s)
centers or teaching
hospitals and 33%/
held Magnet status.
classify it as
unstageable.
Participants were
instructed to use
NPUAP guidelines when
staging the wound or
classifying it as
unstageable.
For part 3 of the test,
participants were asked
to read 5 scenarios and
determine from each
whether the patient's
pressure ulcer was
nosocomial or
community acquired.
NPUAP Guidelines of the
NPUAP and the AHRQ for
pressure ulcer staging and
expert opinion were used to
assess and stage ulcers in
each picture.
The first part of the test
(PrU Identification)
contained 7 pictures of
ulcerous wounds: 3 venous
ulcers, 2 pressure ulcers, 1
arterial ulcer, and 1 diabetic
foot ulcer. The second part
(PrU Stage) contained 18
pictures of pressure ulcers.
During pilot testing, this
section contained 4 pictures
of stage I pressure ulcers, 3
pictures of stage II pressure
ulcers, 5 pictures of stage III
pressure ulcers, 5 pictures
of stage IV pressure ulcers,
and 1 picture of an
unstageable pressure ulcer.
The third part (PrU Source)
contained 5 scenarios that
described a patient's course
of hospitalization.
Two versions of the test
were created because
assessment of the reliability
of pressure ulcer staging
from Web-based
photographs was a new
methodology and subject to
2 limitations relative to inperson assessment.
First, even high-quality
digital images are 2dimensional and will not
provide all of the
information available from
direct observation.
Second, the images
available to raters were
35
Outcome Measures &
Length of Follow-up
SD - 0.18). When data were
collapsed to binary values (pressure
ulcer/not pressure ulcer), K
agreement was 0.84 (SD = 0.25),
with little variation in K values
between wound, continence, and/or
ostomy certified nurses (p< = 0.92,
SD = 0.15) and noncertified nurses
(p = 0.82, SD = 0.27), indicating near
perfect reliability. When the test did
not include wound descriptors, the
adjusted K agreement for pressure
ulcer staging by nurses who were
certified in wound, continence,
and/or ostomy care was 0.66 (SE —
0.04) compared with 0.54 (SE = 0.03)
for noncertified nurses. When the
test included wound descriptors, the
adjusted K value for those certified
in wound, continence, and/or
ostomy care was 0.83 (SE = 0.03)
compared with 0.71 (SE = 0.02) for
noncertified nurses.
Their conclusion states that the
study results suggest that NDNQI
data on pressure ulcers can be used
as an indicator of nursing care
quality and as a tool for guiding
quality improvement initiatives.
Results
Limitations
Treatment Technical Report
References
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
dependent on the quality of
their computer monitors. To
address the 2-dimensional
limitation, the first test
version contained a short
narrative description
(wound descriptor) of each
pressure ulcer in part 2 of
the test. This was done to
provide contextual
information about the
wound ordinarily available
to the rater through direct
wound observation.
Specifically, information
about wound size, depth,
surface characteristics, and
surrounding tissue were
included in the narrative
description that
accompanied the pressure
ulcer photographs. While
this additional information
may have provided details
typically available to an inperson rater, it might
also have cued raters to
consider wound
characteristics that might
not have been noticed
without prompting.
Therefore, the second
version of the test excluded
wound descriptors in part 2
to examine their effect on
the reliability of pressure
ulcer staging and enhance
the comparability of
findings to previous
research studies.
It was anticipated that the
reliability results from the
version containing wound
descriptors would be higher
than the picture-only
36
Results
Limitations
Treatment Technical Report
References
Houwing RH, Arends JW,
Canninga-van Dijk MR,
Koopman E, Haalboom JRE.
Is the distinction between
superficial pressure ulcers
and moisture lesions
justifiable? A clinicalpathologic study. Skinmed.
2007;6(3):113-7.
Nixon J, Cranny G, Bond S.
Pathology, diagnosis, and
classification of pressure
ulcers: comparing clinical
and imaging techniques.
Wound Repair Regen.
2005;13(4):365-72.
Type of Study
Sample
12 lesions with
blanchable erythema
classified as moisture
lesions
Punch biopsy taken 5
mm from superficial
skin defect in
incontinence lesions
and within stage I
A total of 143
patients consented
to participate in the
pilot study (April to
July 1998) and the
main study
(September 1998 to
May 1999), including
93 elective and 50
acute patients.
To detect differences in
mean blood flow
perfusion units)
between clinical skin
grades— Skin lesions
classified as:
0 No skin changes
1a Redness to skin
(blanching)
1b Redness to skin
(nonblanching)
1bþ Redness to skin
(nonblanching) plus one
or more:
Pain
Induration
Heat
Edema
Discoloration
(specify)
2 Partial thickness
wound involving
epidermis/dermis only
3 Full thickness wound
involving subcutaneous
tissue
4 Full thickness wound
through subcutaneous
tissue to muscle or
bone
5 Black eschar
Intervention(s)
Outcome Measures &
Length of Follow-up
version, and that the 2
versions of the test would
bracket the reliability
resulting from bedside, inperson assessments.
4 of the lesions were due to
ischemia and 8 were chronic
irritation
Skin on the buttocks and
sacrum was assessed
immediately
postoperatively and daily
until discharge using a
combination of the
following clinical and
physiological measures:
clinical skin assessment
preoperatively,
postoperatively, and daily
until discharge), laser
Doppler imaging (1/2 hour
and 1 hour postoperatively),
and laser Doppler imaging
of Grade 1b and Grade 1bþ
skin areas observed during
follow-up, where feasible.
37
Stages I through IV are associated
ischemic pathology. Moisture
lesions are associated with a chronic
irritation
Histogram was created of pixels at
each level of tissue injury.
Similarness of pixel levels was
compared. There was a difference
between the levels, with grade iB
(DTI?) the most different
Results
Limitations
Treatment Technical Report
References
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
0 No skin changes
1a Redness to skin
(blanching)
1b Redness to skin (nonblanching)
2 Partial thickness wound
involving
epidermis/dermis only (i.e.
skin break or blister)
3 Full thickness wound
involving subcutaneous
tissue
4 Full thickness wound
through subcutaneous
tissue to muscle or bone
5 Black eschar
Agreement was measured between
CRNs and WNs for the 2396 paired
site assessments for all grades.
There were a total of 508 (21.2%)
disagreements between CRNs and
WNs: 419 were one grade different
(such as 0/1a, 1a/1b and so on), 68
were two grades different [including
0 and 1b (21), 1a and 2 (46) and 3
and 5 (1)], and 21 were more than
two grades different [including 0
and 2 (13), 0 and 3 (1), 1a and 3 (3),
2 and 5 (4)]
Plus a minimum
sample size of 42 scans
was estimated using
pilot study data. This
was based on an
analysis of variance
with 95 percent power
at the 5 percent
significance level.
Nixon J, Thorpe H, Barrow
H, Phillips A, Andrea
Nelson E, Mason SA, et al.
Reliability of pressure ulcer
classification and
diagnosis. J Adv Nurs.
2005;50(6):613-23.
Russell LJ, Reynolds TM.
How accurate are pressure
ulcer grades? An imagebased survey of nurse
performance. J Tissue
Viability. 2001;11(2):67.
Stausberg Jr, Lehmann N,
Krager K, Maier I, Niebel
W. Reliability and validity
of pressure ulcer diagnosis
and grading: an imagebased survey. Int J Nurs
A total of 378 paired
assessments was
undertaken by 116
nurses for the interrater reliability
assessments during
the period from
December 2000 to
February 2001
Thirty images were
selected and classified
with the EPUAP scale,
establishing the gold
standard through
consensus of an expert
panel. Twelve images
were then used for the
study in paper form.
These images were
classified by 97 of 200
contacted nursing
experts from EPUAP
and Great Britain.
About 61.9% of the grades agreed
with the gold standard, the mean
deviation from the gold standard
was 0.49 (standard deviation 0.25).
No pressure ulcer (grade 9
in the analysis);
Pressure ulcer grade 1:
Localized erythema of the
skin; Pressure ulcer grade 2:
Loss of skin; Pressure ulcer
38
Seven participants with 100
assessments each led to 700 grades.
Comparing every two participants
with each other led to 21 pairs with
2100 single comparisons. Half of the
results related to the foot/heel
Results
Limitations
Treatment Technical Report
References
Type of Study
Sample
Stud. 2007;44(8):1316-23.
Verdu J. Can a decision
tree help nurses to grade
and treat pressure ulcers?
J Wound Care.
2003;12(2):45-50.
Intervention(s)
grade 3: Deep loss of skin,
muscles and tendons are
visible and possibly
affected; Pressure ulcer
grade 4: Deep loss of skin
with affection of bones.
Random assignment
of 66 nurses to a
decision tree to
classify pressure
ulcers. Nurses
randomly selected
from 100 at the
General University
Hospital of Elche,
Alicante, Spain. All
had a similar level of
experience and often
cared for patients
with chronic wounds.
At baseline participants
were given a sealed
envelope containing
three clinical case
studies, each of which
briefly described the
health status of a
patient and his or her
pressure ulcer, and
included photographs
of the site and aspect of
the wounds.
Of the 66 nurses, 34 (51.5%)
were assigned to the
control group and 32
(48.5%) to the experimental
Group
Case 1 is a stage I or II
Case 2 is a stage III
Case 3 is a stage IV with
necrotic tissue
Outcome Measures &
Length of Follow-up
region, the other half to the
buttock/hip region (350 grades and
1050 single skin comparisons each).
In about one-third of the images, all
participants agreed concerning the
grade, in about 80% at least five
participants agreed.
Case I*
Results
Limitations
Case II**
Case III***
ConNo.
(%)
Exp.
No. (%)
Con No.
(%)
Exp. No.
(%)
Con No.
(%)
Exp. No.
(%)
Accurate
29 (85.3)
25 (78.1)
18 (52.9)
21 (65.6)
21 (61.8)
14 (43.8)
Inaccurate
5 (14.7)
7 (21.9)
16 (47.1)
11 (34.4)
13 (38.2)
18 (56.2)
There was no statistically significant difference between the grades selected by the two groups.
Overall accuracy rates were:
● Case I: 81.8% (54/66)
● Case II: 59.1% (39/66)
● Case III: 53.0% (35/66)
Photos are blurred
39
Treatment Technical Report
Table 2. Assessment and Monitoring of Healing
Direct Evidence
Reference
Brown GS. Reporting
outcomes for stage IV
pressure ulcer healing: a
proposal. Adv Skin Wound
Care. 2000;13(6):277-83.
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Results
Retrospective
analysis.
Measurement of 10
fully healed stage IV
pressure ulcers in the
pelvic area of 9 patients
were examined
retrospectively.
The demographics of the patients
and theirs wound measurements,
which were taken weekly by 1 of
two wound, ostomy, and continence
nurse during an 18 months period,
were optioned for the analysis.
Linear measurements were used to
calculate the area of the wound.
Volume of the wound was not used.
Average daily reduction in the
wound area was determined for all
10 wounds (initial wound area/ # of
days till full healing). Then the
wounds were stratified into 3
groups: small, medium, and large.
To create and analyze wound
healing curves; individual healing
curve was examined.
Strong link between initial wound size
and healing rate (correlation
coefficient = 0.806).
Lower correlation coefficient
between initial wound size and total
days to full healing (0.720). Leading to
the conclusion that as initial wound
area increases the, the average daily
wound area reduction also increases.
The wound healing curves begin on a
gradual slop but quickly dive
downward as the wound contracts. In
the last phase of epithelialization, the
rate slows considerably. The time to
reach 50% reduction in wound area
for the large, medium, and small
groups was: 26.7%, 42.2%, and 30.1%
of total healing time. The last 10 % of
the healing for the large, medium,
and small groups took 32. %, 33%,
and 33.4% of the total healing time,
respectively. The authors
recommended the use of the 10%
interval data or monogram for
comparing healing rates
prospectively.
Prospective study
17 patients each had at
least one full-thickness
pressure ulcer ( stage III
or VI) that had been
present for at least four
weeks, and
approximately 2 to 150
cm2 in area, not
infected, not include
exposed bone or
cellulitis around the
ulcer, and the patients
The wounds were treated
by:
Eschar removal with sharp
debridement. Wet-to-dry
dressing for further
debridement of tenacious,
fibrous necrotic tissue was
used in some cases.
Sodium chlorideimpregnated gauze was
used as the primary
dressing with calcium
alginate for heavily
exudating wounds.
A hyper-colloid wafer or
foam dressing was used
upon sufficient contraction
and filling of the wound
with new tissue until full
healing.
Date of start of treatment
was considered to begin
upon: (1) initial examination
with heavy to no fibrous
necrotic tissue or slough, if
no Escher was covering the
wound, or (2) debridement
of at least 90% of Escher
covering the wound.
The ulcers were assessed by
the same nurse at the start
of the study and weekly
thereafter for four weeks.
Computer- assisted
planimetry from the tracing
and photographs, and
calculations from the direct
measurements determined
ulcer areas. Wounds were
stratified according to their
size. Ulcer volumes were
The relationship between the ulcer
measurements, the amount and
type of variability within each
measurement, and the changes of
ulcer size during the 4 weeks of
follow-up were examined
statistically.
Areas determined from all
methodologies were very similar
(coefficient > .94, p = .01). The areas
obtained from dimension
measurements from photographs and
tracing slightly over-estimated the
area of the ulcers compared to the
ulcers when compared to the area
obtained by computer-assisted
planimetry (mean difference about
1.5 cm2). There was good agreement
between volumes calculated from
Also in 09 Dressings Table
Cutler NR, George R,
Seifert RD, Brunelle R,
Sramek JJ, McNeill K, et al.
Comparison of quantitative
methodologies to define
chronic pressure ulcer
measurements. Decubitus.
1993;6(6):22-30.
40
Limitations
Area calculated from the
dimension
measurements assumed
all the ulcers were
elliptical in shape. No
attempt was made to
base area calculation on
any other shaped
differentially.
Treatment Technical Report
Reference
van Rijswijk L, Polansky M.
Predictors of time to
healing deep pressure
ulcers. Ostomy Wound
Manage. 1994;40(8):40-2,
4, 6-8 passim.
Type of Study
Secondary analysis.
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
are not critically ill.
calculated by means of
bedside measurements and
Jeltrate volume calculated
weight.
48 patients:
25 men and 22 women.
With 56 full thickness
stage III and IV that
were dressed with
hydrocolloid dressing
for mean of 56 days
prior to the study
enrollment.
Several analysis methods
developed and used on
secondary data:
Kaplan-Meier time until
healing curves were
calculated for time until 50,
80, and 100% healing based
on the ulcer tracing
obtained.
Reduction in ulcer area was
calculated as reduction in
area % from baseline,
controlled by baseline area.
The median time until
healing was calculated for
all patients combined and
as a function of each patient
and ulcer characteristics at
baseline and after two
weeks of treatment.
All calculations performed
50, 80, & 100% healing.
A stepwise Cox proportional
hazards’ model for
prognosis factors of time
until healing 100%.
41
The relationship between outcome
(time to healing deep pressure
ulcer) and the covariates were
assessed (patient and wound
characteristics).
Patients’ characteristics include:
general health condition, mental
statues, mobility, skin condition,
activity level, body build and overall
skin condition, nutritional status.
Wound characteristics include:
aspects of ulcer margin, the
pressure granulation, or necrotic
tissue and depth were assessed at
baseline and every dressing change.
Results
bedside measurements and volumes
determined by Jeltrate impression
(r=.892). Jeltrate impression volumes
tended to yield smaller
measurements than calculated
volumes, especially in larger than 10
cm3 wounds. There was tendency for
Jeltrate impression volume to over
predict calculated volumes in smaller
wounds less than 10 cm3.
Kaplan-Meier time until 100 % healing
time curve showed that the median
time to healing was 69 days. Healing
can be expected to be seen in 25% of
the patients after 50 days, where 75%
of patients can be expected to heal
after 243 days. A 50% reduction in
wound size can be expected after 15
days, where half of all wounds
exhibited an 80 % reduction in ulcer
area after 40 days.
Nutrition status at baseline
significantly influence the time to
healing. Patients with satisfactory/
poor nutritional status at baseline
took a mean of 20 days longer to heal
as compared to patient who had a
good nutritional status (P=0.01).
Patients who were confused/
disoriented healed after a median of
86 days (mean 139, SE 28.7).
Median time to reach 100% healing
for completely immobile patients was
86 days (M 124, SE 27.5) compared to
53 days (M 49, SE 6.5) for patient with
restricted mobility, the differences
was not statistically significant
(p=0.1).
The mean time to healing pressure
ulcers in patients 60 -69 years old was
34.9 days (SE 3.7). Patients< 60 years
of age healed after a mean of 56.4 (SE
6.6) and patients 70 to 79 and >= 80
years of age heal after 78.5 (SE 10.1)
Limitations
Treatment Technical Report
Reference
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Results
Limitations
and 67.1 days (SE 1.9) respectively.
These differences between age
groups were not significant.
The difference of the healing time
between different wound sizes was
not significant (P=0.07).
When baseline area was included in
calculating healing rates, a difference
in time to healing small versus large
wounds was observed, but the
variability of this difference was not
statistically significant.
In stepwise Cox proportional hazards
model only poor nutritional status at
the baseline was found to be
predictive at healing. Age, nutritional
status and % reduction in ulcer area
were all independently predictive of
time to healing after two weeks of
treatment.
Indirect Evidence
Reference
Type of Study
Sample
Intervention(s)
Bryant JL, Brooks TL,
Schmidt B, Mostow EN.
Reliability of wound
measuring techniques in
an outpatient wound
center. Ostomy Wound
Manage 2001;47(4):44-51.
Exploratory
descriptive study,
inter-rater reliability
study.
16 wound care
professional staff; 11
registered nurses and
five physicians.
Subjects were asked to
measure the wound area of
irregular shaped wounds
placed on a prosthetic leg.
Subjects measured asked to
measure the wound using 3
methods: there usual
method of practice,
clockwise method, and
perpendicular method.
Bulstrode CJ, Goode AW,
Scott PJ. Measurement and
prediction of progress in
delayed wound healing. J R
Soc Med. 1987;80(4):2102.
Controlled
experimental study.
30 chronic leg ulcers
were available to
monitor there healing.
Healing was monitored
weekly using stereophotogrammetry from
admission into a controlled
trial to complete healing.
High-definition 3dimensional image of the
wound was photographed.
The surface of the skin and
42
Outcome Measures &
Length of Follow-up
The 3 methods were evaluated
against 2 criteria.1- against gold
standard where the 3
measurements compared (for their
accuracy) with computer assisted
measurement and the surface area
using special calculation. 2- Interrater reliability.
Ulcers were monitored weekly till
healing occurred. Data were used to
define the characteristics in terms of
edge length and area of a healing
ulcer and to attempt to discover any
correlation with the time to
complete healing. The dimensions of
each week were averaged to
produce a standardized healing
Results
Limitations
The perpendicular method is
generally more accurate than the
other two when measuring across
verity of wound configuration.
However, a range of accuracy is
found for each other method
depending on the type of wound
leading to the conclusion that
different measurement methods are
better suited to different wound
shapes.
3 phases for wound healing were
identified. First phase characterized
by actual increase in size, no change
or at the best only a slight decrease
in the size. The second phase was a
rapid healing. The third phase was a
progressively slower healing as the
size of the ulcer decreased to zero.
Percentage change in surface area
Used low technology
method to measure
wound, the study does
not represent true
random sampling, and
results may not be
generalized to all settings
or to full thickness
wounds. (P:50)
“It must be emphasized
that these predictive
values rely on the
availability of a very
accurate measurement
system.
Treatment Technical Report
Reference
Type of Study
Sample
Intervention(s)
the wound are scanned in a
fixed order, the computer
calculated the dimensions,
area and volume, of the
defect.
Outcome Measures &
Length of Follow-up
curve. Absolute changes in edge
length and surface area were
plotted week by week against time
to complete healing.
Eager CA. Monitoring
wound healing in the
home health arena. Adv
Wound Care.
1997;10(5):54-7.
Descriptive study
145 completed surveys
were received from
enterostomal therapy
nurses at 500 home
agencies throughout
the United States.
A questionnaire was
developed using
recommendation on wound
assessment from the
Agency of Health Care
Policy and Research clinical
practice guideline on
pressure ulcer treatment.
The participants were
allowed to add additional
information, and were
asked to include a copy of
current wound
documentation form.
The documentation forms were
evaluated separately from the
questionnaires. And then a
comparison of questionnaire
responses and documentation data
was completed.
Gethin G, Cowman S.
Wound measurement
comparing the use of
acetate tracings and
Visitrak digital planimetry.
J Clin Nurs.
Retrospective
comparative study.
25 acetate wound
tracings of superficial
lower limb wounds
which are < 10 cm2, and
25 acetate tracings of
superficial lower limb
(1) A clear two layered
acetate preprinted in 1 cm2
was placed over the wound
and the perimeter drawn
using fine tip permanent
acetate pen. The tracing
Both sets of wound measurements
were analyzed for differences in
area measurement.
43
Results
was found to provide better
prediction of the time to complete
healing than percentage change of
the edge length.
it was found that if the percentage
change in area in the third week was
multiplied by the factor 0.11 it would
have predicted the total time to
complete healing to within one week
in just under 50% of the ulcers.
Pressure ulcer is the most commonly
treated (97%) type of wound in U.S
home health care agencies.
The average number of wounds seen
by an agency is 152/month.
The documentation forms used by
these agencies most commonly asked
clinician to document: date, site, or
location of the wound, size by length
and width, tissue type and color, the
surrounding skin description, type
and amount and of drainage, and
odor of the wound.
74% of respondents do wound
assessment at least weekly, 26% do it
less frequently or inconsistently.
54% of respondents monitor healing
by: change in length and width,
drainage, wound bed, wound edges,
pain, and odor.
90% of the agencies use the NPUAP
guidelines in their wound
assessment.
The comparison of questionnaire
responses and documentation data
revealed a general lack of universal
documentation standards, especially
in: documented medications, pain,
compliance, and peri-wound area.
The difference between area
measurements was not clinically
significant between the two
measures (t=0.995, d.f.= 24,
p=0.330). In the wound group<10
cm2, the mean wound measurement
Limitations
The surveys were
received from
respondents representing
34 states.
Lack of sufficient tracing
after 4 weeks resulted in
inability to achieve the
second aim of the study.
The study cannot be
generalized to a wider
Treatment Technical Report
Reference
Type of Study
2006;15(4):422-7.
Griffin JW, Tolley EA,
Tooms RE, Reyes RA, Clifft
JK. A comparison of
photographic and
transparency-based
methods for measuring
wound surface area. Phys
Ther. 1993;73(2):117-22.
Descriptive
correlational study.
Sample
Intervention(s)
wounds which are > 10
cm2.
date then identified. The
racing was later placed onto
the Visitrak™ unit and the
perimeter stylus so that the
underlying sensor could
calculate the area.
(2) The wound area was
calculated manually by
counting squares
completely within the
wound border and those
more than half full within
the border were counted as
1 cm2.
To assess test-retest
reliability of wound surface
area measurement, 5 ulcers
were assessed using both
photographic and
transparency methods, and
assessments were repeated
after one hour. To compare
the wound surface area
measurement obtained by
the photographic and
transparency methods, all
22 ulcers were measured on
a single occasion using each
method. To compare
photographic and
transparency wound surface
area measurement over
time, the 16 ulcer that were
available for longitudinal
study were measured at 5
day intervals for 20 days,
using each method.
20 inpatients (18 male,
2 female). A total of 22
ulcers were studied.
Outcome Measures &
Length of Follow-up
44
Results
Limitations
was 3.68 cm2 using acetate and 3.54
cm2 using Visitrak™. In the wounds
group .10 cm2, the mean wound
measurement using acetate was
24.96 and 24.31 cm2 using Visitrak™.
The difference between the methods
used to measure wound increased
with the size of the wound.
range of practitioners or
centers because the
study was conducted in
one center where a high
degree of skill is available
in wound measuring. The
study did not study cavity
wounds or wounds in
difficult areas, and the
depth gauge of the cavity
wounds was not
evaluated using the
Visitrak™.
(1)A high degree of intra-rater
reliability was demonstrated for
repeated measurement obtained
with both photographic and
transparency method. The
transparency and the photographic
methods provided equivalently
reliable wound measurement,
whether the mean of the three
measurements or single
measurements were used.
(2) Precision was slightly improvised
by using the average of three
measurements, particularly for the
photographic method. Time and
expenses involved in analyzing three
tracing versus a single tracing might
not be justified for such a small
increase in precision.
(3) Photographic and transparency
method wound surface area
measurements were significantly
correlated in the 22 ulcers (r=.99, p =
.001), and the tracings did not differ
significantly.
(4) Significant correlation between
methods was consistent, as healing
occurred in the 16 ulcers followed
over time. The two methods
continued to yield equivalent
measurements as ulcer became
The wounds in this study
were limited to pressure
ulcers in the pelvic region
of patients with spinal
cord injury, findings
might not be
representative of wounds
having different
etiologies or different
body locations.
Treatment Technical Report
Reference
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Haghpanah S, Bogie K,
Wang X, Banks PG, Ho CH.
Reliability of electronic
versus manual wound
measurement techniques.
Arch Phys Med Rehabil.
2006;87(10):1396-402.
Repeated measures.
4 trained blinded
observers, drawn from
the clinical and research
staff of the spinal cord
injury unit.
40 simulated wounds were
measured by each observer
using the 3 techniques. The
observers measured the
wounds in 2 separate
sessions with a minimum of
7 days between the sessions
to minimize memory effect.
Data were stratified and
analyzed for 2 large and
small wounds.
Inter-observer and intra-observer
variability.
For accuracy: the average root mean
square error (RMSE) for each
measurement technique was
determined.
Hegarty C. VISITRAK. 2nd
World Union of Wound
Healing Societies' Meeting.
Paris, France 2004. p. 125.
Langemo DK, Melland H,
Hanson D, Olson B, Hunter
S, Henly SJ. Twodimensional wound
measurement: comparison
of 4 techniques. Adv
Wound
Comparative study.
66 raters,
representative of a
verity of skill levels in
wound measurement.
32 upper-division
undergraduate nursing
students, 27 staff
Each assessor measured the
area of each of the 3
predefined templates; 5
times using VISITRAK digital
and 5 tomes using the
Counting Squares.
The areas measured and the time
taken to obtain the area
measurement was recorded.
Three wound models were
used (Paris bases painted).
Each rater measured the
entire outer perimeter of
each of the 3 wounds using:
ruler length and width,
tracing on transparency,
The relative bias and standard error
of measurement for each technique,
for each wound shape was
calculated. The relative bias and
standard error of measurement was
obtained by taking the average of 2
measurements for each technique
45
Results
smaller.
For large wounds inter-observer
variation was significant for all
measurement techniques and intraobserver variation was not significant
for any measurement technique.
For small wounds intra-observer
variation was not significant for linear
and Visitrak but was significant for
VeV, were inter-observer variation
showed the reveres result.
The linear measurement technique
the lowest accuracy for all
measurement techniques and all
observers; it showed very high RMSE
values for both large (mean =110)
and small wounds (mean = 29). For
large wounds Visitrak and VeV
showed the lowest RMSE values, with
VeV slightly better (mean= 22) than
Visitrak.(mean = 27). For small
wounds Visitrak and VeV showed the
lowest RMSE values, with Visitrak
even lower (mean = 3) than VeV
(mean = 5).
There was a significant evidence
(P<0.001) than counting squares took
longer than VISITRAK Digital to
measure each of the template areas.
There was a significant evidence
(P<0.01) that the counting squares
method of the estimating the
template area was more variable
than VISITRAK Digital estimating the
template area was more variable
than VISITRAK Digital for each of the
templates.
1-The smallest relative bias was
associated with the SPG method. The
ruler length and width measurement
reflected the largest bias regardless
of wound shape.
2-The SPG area had the smallest SEM
for each wound shape. Both length
Limitations
Use of simulated wounds,
in a highly controlled
conditions.
Use of wound models
rather than real wounds.
Treatment Technical Report
Reference
Type of Study
Care.1998;11(7):337-43.
Sample
Intervention(s)
nurses and graduate
nursing students, 6
wound care nurses, and
1 whose status was not
revealed.
SPG length and width, and
SPG area.
3 physical therapists made
two tracings of each wound
by tracing the wound
perimeter on a sterile
transparency with a marker.
The two tracings of each
wound were designated as
a pair of tracings. One
therapist traced 34 wounds
and the other two
therapists each traced 18
wounds. Each therapist
independently determined
the area of the tracing by
each of the following four
methods.
The area, volume, and
depth of the wounds were
measured using a
structured light
measurement technique.
The software was modified
Majeske C. Reliability of
wound surface area
measurements. Phys Ther.
1992;72(2):138-41.
Descriptive
comparative study.
31 patients with
unhealed venous stasis
ulcer.
Melhuish JM, Plassman P,
Harding KG.
Circumference, area and
volume of the healing
wound. J Wound Care.
1994;3(8):380-4.
Descriptive
comparative study.
14 patients were
studied. 7 patients had
healing pilonidal sinuses
and 7 patients had
abdominal wall cavity
wound arising from
46
Outcome Measures &
Length of Follow-up
by wound combination. Inter-rater
reliability was obtained by
measuring the intra-class
correlation. the interclass (Person)
correlation had been used to
evaluate the intra-rater reliability.
Inter-tester and intra-tester
reliability of four methods of
measuring wound area was
determined.
Mean wound areas from each
method were compared for
differences.
All wounds were measured weekly
in the clinical environment. Duration
of the study: 10 weeks. Comparison
between area, volume, and
circumference was done. Spearman
correlation coefficient used.
Results
and width methods best measured
circular wounds, followed by the Lshaped and the pear shaped wounds.
Tracing worked best for the pearshaped wounds, whereas SPG area
had the smallest SEM for the Lshaped wound.
3-The inter-rater reliability of average
rating was high for all techniques.
The clinically relevant reliabilities for
single rating were low(.3-.53), except
for the SPG area technique (.87).
4-Intra-rater reliability was high for
the tracing method and low for the
SPg area method, with the two length
and width method between the
tracing and the SPG area methods.
The overall results of this study
indicate that: the computer (SPG)
area technique was found to be the
most accurate and least biased for
two-dimensional wound
measurement.
Intra-tester reliability for each
therapist using the 4 methods of
calculating wound area was high, all
correlation coefficient were .99.
Inter-tester reliability was high the
ICC value ranged from .97-.99.
Results show that the circumference
of the wound is related to both the
volume and the area. There is a
stronger relationship between area
and circumference (0.95, P<0.001),
than volume and circumference
Limitations
Error from the
approximation of the true
wound area may had
been occurred due to
individual differences in
assessing wound’s
borders, or altered
wound size because of
the placement of the
transparency over the
wound..
Treatment Technical Report
Reference
Type of Study
Sample
Intervention(s)
surgical procedures.
to measure the 3dimensional circumference
of the wound.
The PUSH tool was used to
assess venous leg ulcers of
the sample group at each
visit to the clinic. Inter-rater
reliability for the tool was
established at the beginning
of the study. The trend of
the PUSH score was
compared to the individual
subject’s venous ulcer
healing trend to determine
whether the healing trend
was consistent over time.
Inter-rater and intra-rater’s
reliability were established
by the 4 nurses traced the
wounds using the VISTRAK
wound measurement
system/ only one assessor
carried out the tracing, then
the traced wound areas
were redrawn three times
by each assessor onto the
digital pad using the
accessory pen in the
laboratory.
Concurrent validity was
assessed by comparing the
VISITRAK wound area
measurement with the
digital planimetry as a
standard. The wound area
in the digital planimetry
photographs were
measured 3 times each by
Ratliff CR, Rodeheaver GT.
Use of the PUSH tool to
measure venous ulcer
healing. Ostomy Wound
Manage. 2005;51(5):58.
Descriptive
exploratory study.
27 patients with venous
ulcer were followed.
Sugama J, Matsui Y,
Sanada H, Konya C, Okuwa
M, Kitagawa A. A study of
the efficiency and
convenience of an
advanced portable Wound
Measurement System
(VISITRAK). J Clin Nurs.
2007;16(7):1265-9.
Descriptive
correlational study.
To test the reliability:
10 inpatients, 7 females
and 3 males, with
pressure ulcer in a longterm facility.
To test the validity: 30
inpatients with pressure
ulcers or develop
pressure ulcers during
the validity test period,
which is 6 months.
Outcome Measures &
Length of Follow-up
47
The patients were followed
monthly for 2 months using the
PUSH tool at each visit
The outcome to assess reliability is
intra-class correlation coefficient.
The outcome to assess concurrent
validity: the coloration coefficient
between VISITRAK and digital
planimetry, which was calculated
from the average of three
measurements, which was similar to
the protocol of followed for the
reliability test.
Measurement outcome for the
convenience of the VISITRAK:
comparing duration of time of
measurement against that of the
digital planimetry.
Results
(0.79. P = 0.001). comparing the
parameters during healing follow-up;
the volume, area, and circumference
measurement followed a similar
pattern in all the patients until
wound closer, with the correlation
between area and circumferences
was 0.94 (p<0.001), and the between
volume and circumference was 0.80
(p<0.01).
The mean scores of the PUSH were
different indicating a sensitivity to
change and scores were consistent
with outcome (P: 63). So in
conclusion the PUSH tool represents
an excellent starting point to validate
healing of venous ulcer (P: 64).
The inter-rater and intra-rater
reliabilities for the VISITRAK were
excellent ( ICC= 0.99- o.75).
There was a significant strong
positive correlation between the two
wound measuring area
techniques(r=0.99, p,0.001).
The VISITRAK is significantly quicker
(median = 54 seconds) than the
digital planimetry (median = 126
seconds).
In conclusion: VISITRAK wound
measurement system is an efficient
wound measurement device.
Limitations
Small sample size.
Treatment Technical Report
Reference
Type of Study
Sample
Taylor RJ. Mouseyes
revisited: upgrading a
computer program that
aids wound measurement.
J Wound Care.
2002;11(6):213-6.
Descriptive study
Information was not
provided.
Thawer HA, Houghton PE,
Woodbury MG, Keast D,
Campbell K. A comparison
of computer-assisted and
Inter-rater reliability
study.
45 out patients with
lower extremities
wounds of varied sizes,
and etiologies, and 38
Intervention(s)
each assessor with a digital
planimetry.
Convenience of the
VISITRAK was assessed by
recording the time it took to
calculate wound area in the
time taken to trace the
wound and measure the
area by VISITRAK
measurement system, and
the time required for
scanning and measurement
using the digital planimetry.
Two types of wound images
were entered to the
program: 1) securing a
wound tracing to the
computer screen and
recording the outline with
the mouse-controlled
graphics cursor, 2) working
with an image file derived
from a digital camera or
camcorder, saved onto
operation of the program.
Calibration and
measurement were done.
Each polygon’s outlines was
traced a total of 10 times
and the results entered into
SPSS for windows (release
10.0) spreadsheet. Group
means, standard deviations,
and coefficients of variation
(standard deviation divided
by the mean) were then
calculated. The significant of
difference between the true
and the measured result
was investigated using t-test
(p<0.05).
The new technique is a
variation of the Stereophotogrammetry method of
wound measurement. The
48
Outcome Measures &
Length of Follow-up
Results
Limitations
Comparing the levels of
reproducibility and agreement with
the true areas of the temple
measurement.
The program showed excellent levels
of reproducibility and agreement
with the true areas of the temples.
This version was less accurate in
tracing the wound than the previous
version, but exhibits a higher level of
reproducibility.
No information about the
number of images that
were used in this study.
1-The intra-rater and interrater
reliability of the new computerized
technique when assess surface area
of human wounds.
Both computerized and manual
techniques were reliable
measurement technique for assessing
the surface area of human and
Treatment Technical Report
Reference
Type of Study
manual wound size
measurement. Ostomy
Wound Manage.
2002;48(10):46-53.
Thomas AC, Wysocki AB.
The healing wound: a
comparison of three
clinically useful methods of
measurement. Decubitus.
1990;3(1):18.
Cross-sectional
comparative study.
Sample
Intervention(s)
CD-1 male mice chosen
on random bases.
new technique utilize single
digital camera and a
software, it provide serial
images for the wound and
determine both wound
dimensions and visual
characteristics.
Total of 73 patients
with chronic wounds:
36 were with venous
stasis ulcers and 37 with
decubitus ulcers.
Wounds were measured
using each of the 3
methods; two
measurements for each
observation were made
using each device to ensure
reliability.
49
Outcome Measures &
Length of Follow-up
2-Compare the inter-rater and intrarater reliability of the new technique
to reliability of well-established new
technique.
3-The reliability and validity of the
new technique in measuring small
wounds such as those found on
animals in laboratory experiments.
Evaluate the precision of each
technique when the average of 3
repeated measures of the surface
area are used compared with single
measurement of surface area.

Results
animal wounds (P: 50). The
measurement of surface area
obtained by using the manual
technique was greater than those
obtained by computerized technique
(P: 50). Measuring smaller animal
wounds using the computerized
technique was more precise and
reliable than other techniques.
Taking the average of 3 repeated
measurements of surface area
resulted in:
Improvement in inter-rater reliability
of each measurement technique for
both human and animal wounds.
 Improvement in the precision of
each technique with human wounds
Improvement in the precision of the
manual technique with the animal
wounds. (P: 50)
Comparing the measured areas of
Comparison of the three methods,
actual healing wound using Pearson
when data from both types of
correlation and repeated
wounds were combined, revealed
measurement analysis of variance
high correlation (r = .99). However,
(ANOVA) with follow-up
the 3 methods were significantly
comparison.
different from each other in terms of
measurements of actual wound
area.. The difference was remarkable
between Kundin method and other
two methods, it consistently
underestimate wound area,
especially in wounds of large area
and irregular shapes.
Limitations
Treatment Technical Report
Table 3. Role of Nutrition in Pressure Ulcer Healing
Direct Evidence
Limitations
Type of Study
Sample
Intervention(s)
Benati G, Delvecchio S,
Cilla D, Pedone V. Impact
on pressure ulcer healing
of an arginine-enriched
nutritional solution in
patients with severe
cognitive impairment. Arch
Gerontol Geriatr.
2001;7:43-7.
Randomized, cohort,
clinical trial
n=36, inpatients with
cognitive impairments
and PrU
2 week intervention
Received oral nutritional
supplementation enriched
with protein (37 g/d) or
protein plus arginine (7.5
g/d), zinc (25 mg/d), and
antioxidant vitamins
A: Normal hospital diet
B: Hospital diet + High
protein calorie solution
C: Hospital Diet +ONS is
caloric, isonitrogenous
enriched in Arginine,
vitamins and trace elements
with antioxidant effects
Control: Standard diet, 1800
cal/day
Nutrition Intervention for
15 days: 2 ONS/day, each
providing 200 kcal, 30%
protein, 20% fat, 50%
carbohydrate, 1.8 mg zinc,
15 mg vitamin C
(Jacquemaire-Sante;
Nutricia; Clintec-Sopharga)
Evidence Level = III
Bourdel-Marchasson I,
Barateau M, Rondeau V,
Dequae-Merchadou L,
Salles-Montaudon N,
Emeriau JP, et al. A multicenter trial of the effects
of oral nutritional
supplementation in
critically ill older
inpatients. GAGE Group.
Groupe Aquitain
Geriatrique d'Evaluation.
Nutrition. 2000;16(1):1-5.
Examined the effects
of high energyprotein supplement
enriched with
arginine, zinc and
antioxidants on
pressure ulcer
healing in patients
with severe cognitive
impairment and
reduced oral food
intake.
Multicenter,
randomized clinical
trial
Effect of nutritional
supplementation on
dietary intake and on
PrU development in
critically ill older
patients
19 wards stratified: 9
wards randomly
selected for ONS
intervention
n=672; 377 in control;
295 in ONS
>60% female; Age =83.3
years; BW=55.2-60.2 kg
Control group at higher
risk of PrU per Norton
and Kuntzmann score
ONS group at higher
risk of PrU per serum
albumin levels
Outcome Measures &
Length of Follow-up
PSST scores
Results
Group C: Pressure sore status tool
(PSST) scores for patients on the oral
supplementation exhibited rapid
improvement in pressure ulcer
healing, compared to patients on the
standard hospital diet with no
supplementation. Patients receiving
the protein + arginine + zinc +
antioxidant supplement had the
lowest PSST scores.
Sample size
No statistical analysis
PrU grades (AHCPR)
PrU incidence
Nutritional intake
Higher energy and protein intake on
ONS group (1081 kcal vs. 957 kcal,
p<0.006; 45.9 g protein vs. 38.3 g
protein, p<0.001)
PrU cumulative incidence:
Day 5: 16% ONS vs. 25% control
Day 10: 27% ONS vs. 37% control
End of follow-up: 40% ONS vs. 48%
control
Hypoalbuminemia, lower limb
fracture, Norton score <10 vs. >14,
high Kuntzman score, belonging to
control group were independent risk
factors for PrU development
Belonging to the ONS group was a
protective factor
At baseline all patients had low levels
of serum albumin & zinc and elevated
CRP; normal transthyretin levels
After 3 weeks:
94% compliance with ONS
No significant changes in oral dietary
intake, body weight & biochemical
markers
Trend in body weight increase (1.2,
0.4, 1.1 kg in diets A, B, C, resp)
Randomization by center
not individual
Different baseline risks of
study groups
No information on other
medical interventions
Evidence Level = I
Desneves KJ, Todorovic BE,
Cassar A, Crowe TC.
Treatment with
supplementary arginine,
vitamin C and zinc in
patients with pressure
ulcers: a randomized
controlled trial. Clin Nutr
2005; 24:979-987.
Randomized clinical
trial
Determine
nutritional status of
patients dx with preexisting PrU &
determine whether
nutrients putatively
implicated in PrU
n=16
Age: 37-92 years; BMI =
16.4-28.1
Stage 2, 3, 4 PrU
3 week intervention
A: Standard hospital diet
B: Standard diet + 2 highprotein/energy ONS (500
kcal, 18 g protein, 72 mg
vitamin C, 7.5 mg zinc;
Resource Fruit Beverage,
Novartis)
C: Standard diet + 2 highprotein/energy
Body weight
Blood biochemistry
Pressure ulcer severity: PUSH scores
Food and fluid intake
50
Sample size
Treatment Technical Report
Limitations
Evidence Level = II
Frias Soriano L, Lage
Vázquez MA, Maristany
CP, Xandri Graupera JM,
Wouters-Wesseling W,
Wagenaar L. The
effectiveness of oral
nutritional
supplementation in the
healing of pressure ulcers.
J Wound Care.
2004;13(8):319-22.
Evidence Level = V
Guenter P, Malyszek R,
Bliss DZ, Steffe T, O'Hara D,
LaVan F, et al. Survey of
nutritional status in newly
hospitalized patients with
stage III or stage IV
pressure ulcers. Adv Skin
Wound Care. 2000;13(4 Pt
1):164-8.
Type of Study
Sample
healing (arginine,
vitamin C, zinc) will
improve rate of PrU
healing
Open Intervention
Study Multicenter,
open intervention,
non-placebo
controlled clinical
study
Outcome Measures &
Length of Follow-up
supplements (500 kcal, 21 g
protein, 9 g additional
arginine, 500 mg vitamin C,
50 mg zinc; Resource
Arginaid Extra, Novartis)
n=63 included in study
but n=39 completed
Mean age = 74 y, 54%
female, 46% male, BMI
= 22.9, 24% were
nutritionally depleted
Grade III or IV PrU
Oral nutrition supplement
daily for 3 weeks
Cubitan (Nutricia) per 200
mL provided: 250 kcal, 20 g
protein (3 g arginine), 28.4 g
carbohydrate, 7 g fat, 250
mg vitamin C, 37.6 mg α-TE,
9 mg zinc; all other
micronutrients present at 8150% of US RDA for >50
years of age
Weekly assessment of:
Nutritional intake
Wound area
Wound condition
Anthropometric data collected at
baseline and week 3
n=120 non-ICU patients
with Stage III or IV PrU
No intervention
Body weight
Blood biochemistry
Nutritional intake
Type of PrU
Effectiveness of oral
nutritional
supplement that is
rich in protein,
enriched in arginine,
vitamin C, and zinc,
on healing of
pressure ulcers
Descriptive
Study(Prospective
and Retrospective)
Intervention(s)
Examine the
nutritional status of
newly hospitalized
patients with Stage
III or Stage IV PrU
51
Results
Significant (p<0.05) improvements in
SH scores in Diet C compared to
baseline (9.4 vs. 4.4 at week 2, 2.6 at
week 3)
Significantly (p<0.05) lower PUSH
scores at week 3 in Diet C (2.6) vs.
Diets A (7.0) & B (6.0)
Diet A: significant (p<0.05)
improvements in PrU healing
Diet C: 2.5 fold greater improvement
in pressure ulcer healing after 3
weeks compared to other 2 diet
groups
No differences in energy & protein
intakes across groups
Significantly (p<0.05) higher intakes
of arginine, vitamin C, zinc in Diet C
After 3 Weeks:
Significant reductions (29%) in wound
area from 23.6 cm2 to 19.2 cm2
(p<0.001)
Median healing of 0.34 cm2 per day
Trend in reduction of amount of
exudates in infected ulcers (p=0.012)
Significant reduction in incidence of
necrotic tissue (p=0.001)
No significant change in body weight,
BMI
ONS consumption = 1.9 packs/day
37% perceived adequate oral intake,
29% took 75-100%, 34% took 50-75%
of required energy intakes
No effect of intervention, i.e.
improvements in nutritional status of
depleted patients
Majority of patients were elderly
(58%), & females (53%). Stage III
sacral ulcers most common (74.2%).
Most patients were below UBW, had
low serum prealbumin and albumin
levels (88% and 92%). 75% of patients
had moderately low or severely low
serum prealbumin levels. 59% of
patients had low or severely low
serum albumin levels. Nutritional
Open study design, no
blinding of investigators
Completers only analysis
Drop-out rate (38%)
Healing rates compared
to historical controls
No information on total
nutrient intake, medical
status, medical
interventions
Descriptive study; Limited
information on nutrient
intake
Treatment Technical Report
Limitations
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Results
intakes were inadequate to meet
needs of patients, met 55% of needs
Evidence Level = V
Horn SD, Bender SA,
Ferguson ML, Smout RJ,
Bergstrom N, Taler G, et al.
The National Pressure
Ulcer Long-Term Care
Study: pressure ulcer
development in long-term
care residents. J Am
Geriatr Soc.
2004;52(3):359-67.
Retrospective, cohort
study
Identify resident,
treatment, facility
characteristics
associated with PrU
development in longterm care residents
95 LTC in US
1524 residents, >18 y,
>14 d LOS, at risk of
developing PrU, Braden
Score <17 on entry
No intervention
Over 12 weeks:
Resident characteristics
Treatment characteristics
Staffing ratios
Facility characteristics
PrU development during study
n=103; placebo=52;
ONS=51
Age: 81 years; BMI=24
28-day intervention or until
discharge
Supplementation started
after surgery
Placebo: water-based, noncaloric ONS
ONS: 400 ml/d; 40 g
protein, 6 g arginine, 20 mg
zinc, 500 mg vitamin C, 200
mg α-TE, 4 mg carotenoids
Presence and stage of PrU (EPUAP)
Published randomized
controlled trials
Enteral and parenteral
nutrition support
Incidence of new PrU
Ulcer healing or changes in PrU
severity
Evidence Level = V
Also in Table on
Assessment
Houwing RH, Rozendaal M,
Wouters-Wesseling W,
Beulens JWJ, Buskens E,
Haalboom JR. A
randomised, double-blind
assessment of the effect of
nutritional
supplementation on the
prevention of pressure
ulcers in hip-fracture
patients. Clin Nutr.
2003;22(4):401-5.
Double-blind,
randomized,
placebo-controlled
clinical trial
Effect of nutritional
supplementation on
incidence of PrU in
hip-fracture patients
at risk of developing
PrU
Evidence Level = II
Langer G, Schloemer G,
Knerr A, Kuss O, Behrens J.
Nutritional interventions
for preventing and treating
pressure ulcers. Cochrane
Database Syst Rev.2003;(4)
CD003216.
Systematic review
Evaluate
effectiveness of
enteral and
parenteral nutrition
on the prevention
and treatment of
52
During 12-week period:
71% did not develop PrU
29% developed PrU
Characteristics associated with
development of PrU: higher initial
severity of illness, history of recent
PrU, significant weight loss, oral
eating problems, use of catheters,
use of positioning devices.
Characteristics associated with
decreased likelihood of PrU: new
resident, use of ONS, tube feeding for
>21 days, antidepressant use, use of
disposable briefs, RN hours of 0.25
hours/resident/day, LPN turnover
<25%
70% of patients consumed ONS for 1
week or more
75% of patients consumed 75% or
more of daily dose
57% of all patients developed PrU,
23% developed Stage 2 PrU
Incidence of PrU was not different
between placebo (59%) vs. ONS
(55%)
Incidence of Stage 2 PrU was lower
(9%) in ONS (19%) vs. placebo (28%)
Trend (p=0.09)towards later onset of
PrU in ONS group (3.6 days) vs.
placebo (1.6 days)
Number of days of prevalent PrU
lower in ONS vs. Placebo group (4.4
vs. 5.0 d)
Convenience sample
No data on type of
nutritional interventions
and its impact on PrU
8 RCT trials out of 16 potentially
relevant studies were included
4 studies evaluated effects of
nutritional supplements for
treatment of existing PrU: 1 with
mixed nutritional supplements, 1
with zinc; 1 with protein; 2 with
ascorbic acid
Small studies
Methodological issues
Power and sample size
No information on
nutrient intake & other
medical interventions
Treatment Technical Report
Limitations
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
pressure ulcers
Langkamp-Henken B,
Herrlinger Garcia KA,
Stechmiller JK, Nickerson
Troy JA, Lewis B, Moffatt L.
Arginine supplementation
is well tolerated but does
not enhance mitogeninduced lymphocyte
proliferation in elderly
nursing home residents
with pressure ulcers. JPEN
J Parenter Enteral Nutr.
2000;24(5):280Evidence Level = II
Lee SK, Posthauer ME,
Dorner B, Redovian V,
Maloney MJ. Pressure
ulcer healing with a
concentrated, fortified,
collagen protein
hydrolysate supplement: a
randomized controlled
trial. Adv Skin Wound Care.
2006;19(2):92-6.
Evidence Level = II
Raffoul W, Far MS, Cayeux
M-C, Berger MM.
Nutritional status and food
Randomized clinical
trial
Determine level of
arginine
supplementation
that is orally and
metabolically
tolerated and
effective in
enhancing immune
function in elderly
patients with PrU
Randomized,
prospective, doubleblind, placebocontrolled
multicenter trial
Compared PrUs
scores at 8 weeks in
long-term care
residents with PrU
given standard care
plus a concentrated,
fortified, collagen
protein hydrolysate
supplement vs.
residents given
standard care plus
placebo
Prospective, noncomparative,
observational, cohort
0 g Arg: n=10, 82 y
8.5 g Arg: n=11; 81 y
17 g Arg: n=11; 87 y
2 LCTs
4 weeks of supplementation
Arginine supplementation: 0
g, 8.5 g, 17 g
Nutritional status & intake
Oral tolerance: nausea, vomiting,
abdominal distention, diarrhea
Metabolic tolerance: serum
electrolytes
Immune function: IL2 production;
Lymphocyte proliferation
23 long-term-care
facilities in 4 states
n=89; 71 completed
study
n=56 intervention; n=33
placebo
Stage 2, 3, 4 PrU
8 week intervention
Standard care plus
concentrated, fortified,
collagen protein hydrolysate
(15 g in 45 mL unit dose,
ProStat, Medical Nutrition
USA) vs. placebo
Wound healing: PUSH scores
Frequency of PrU stage by group
Supplement intake
n=9
Age=71 y; BMI=23.3
Started 5 days prior to sx
until 10 days after sx
Encouraging oral food
BMI, food intake, blood chemistries
53
Results
Not possible to draw a firm
conclusion on the effect of enteral
and parenteral nutrition on the
prevention and treatment of PrU
Dietary supplementation may
prevent PrU in acutely ill older
people, more research is needed to
identify effective dietary
interventions
%IBW, serum albumin levels did not
change over the 4-week
supplementation period
Total energy and protein intake and
% weight change were not different
among Arg supplementation groups
Significant increase in plasma
Arginine with supplementation
Good oral and metabolic tolerance
Arginine supplementation did not
enhance proliferative responses
4 weeks of Arginine supplementation
resulted in significant (p<0.05)
decrease in lymphocyte proliferation
in supplement groups 17 g vs. 8.5 g
75 PrU in intervention & 33 in control
group
After 8 weeks:
PUSH scores decreased for all
patients; twice rate of healing in
intervention group vs. control
Significantly better PUSH scores in
intervention group vs. placebo (3.55
vs. 3.22, p<0.05)
Anemia and inflammation in 4
patients
Highly variable food intake, meeting
No report of PrU healing
rates
Randomization process;
group differences at
baseline
Data variability & analysis
Convenience sample
No information on
patient medical status,
nutrient & other medical
intervention data
Study design
Treatment Technical Report
Limitations
Type of Study
intake in nine patients with
chronic low-limb ulcers
and pressure ulcers:
importance of oral
supplements. Nutrition.
2006;22(1):82-8.
study
Evidence Level = V
Reddy M, Gill SS, Rochon
PA. Preventing pressure
ulcers: a systematic
review. JAMA. 2006;
296:974-84.
Evidence Level = I
Spungen AM, Koehler KM,
Modeste-Duncan R, Rasul
M, Cytryn AS, Bauman WA.
9 clinical cases of
nonhealing pressure ulcers
in patients with spinal cord
injury treated with an
anabolic agent: a
therapeutic trial. Adv Skin
Wound Care.
2001;14(3):139-44.
Evidence Level = V
Stechmiller JK, LangkampHenken B, Childress B,
Herrlinger-Garcia KA,
Hudgens J, Tian L, Percival
SS, Steely R. Arginine
supplementation does not
enhance serum nitric oxide
levels in elderly nursing
home residents with
pressure ulcers. Biol Res
Nurs. 2005; 6:289-99.
Investigate the
micronutrient status,
food intake and role
of ONS in elderly
patients with chronic
low-limb ulcers and
PrU
Identify nutritional
risk factors of
delayed wound
healing
Systematic review
Systematically review
the evidence
examining
interventions to
prevent PrU
Case studies
Examined effect of
oxandrolone and
glutamine of PrU
healing in spinal cord
injury patients with
PrU
Randomized clinical
trial
Determine if arginine
supplementation
enhances in vitro and
in vivo measures of
immune function in
nursing home elderly
with PrU
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
intake; standardized diet
(300 kcal at breakfast, 700
kcal at lunch, 700 kcal at
dinner)
1-4 units of ONS/d provided
(each unit providing 300
kcal, 11.2 g protein,
predominantly Clinutren,
Nestle)
One multivitamin tablet/day
500 mg vitamin C/d
Results
31-95% of energy intake
ONS were willingly consumed (2.4
units/d), meeting 35% of energy &
40% of protein requirements
Selenium & zinc requirements were
not met
Complete wound healing achieved in
all cases; 7 of 9 having straight
healing
5 RCTs targeted
impaired nutrition
interventions
1475 patients: 66% in
acute care, 34% in LTC
varied
PrU prevention
In patients with nutritional
impairments, dietary supplements
may be beneficial
Study designs,
randomization, blinding,
interventions
n=9; Spinal cord injury
patients with nonhealing pressure ulcers
or full-thickness
pressure ulcer
Patients treated with
oxandrolone (20 mg/d) and
glutamine (20 g/d) from 1 to
12 months
Wound healing
89% of patients had completely
healed wounds within 3 to 12 months
Study design
Sample size
n=26; >65 years, with
PrU
4 week Arginine
supplementation
8.5 g L-Arginine
Isonitrogenous supplement
(22.4 g Promod containing
0.4 g arginine)
3 servings/d of 50 mL each
10 week follow-up
Immune function measures:
Neutrophil burst, mitogen-induced
lymphocyte proliferation, DTH, NO
Serum amino acid levels
Good compliance and tolerance of
supplements
Trend in rising serum Arg levels; by
week 10 significant. decline observed
in serum Arg level in Arg-supplement
group
Significant increase in serum
ornithine (p<0.01) in Arg-suppl group
No significant difference in
lymphocyte proliferation in both
groups at week 4 vs. baseline;
significant difference between suppl
No information on PrU
healing, incidence
54
Treatment Technical Report
Limitations
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Evidence Level = II
Stratton RJ, Ek A-C, Engfer
M, Moore Z, Rigby P,
Wolfe R, Elia M. Enteral
nutritional support in
prevention and treatment
of pressure ulcers: A
systematic review and
meta-analysis. Ageing Res
Rev. 2005; 4:422-50.
Systematic review,
Meta-analysis
Determine effect of
enteral nutritional
support on PrU
incidence, healing
QOL, complications,
mortality, nutritional
status
36 studies met inclusion
criteria. 15 RCTs
included in systematic
review. 5 RCTS
comparing ONS and
enteral tube feeding
included in metaanalysis
ONSTube Feeding
PrU incidence
Healing
QOL
Complications
Mortality
Dietary intake
Nutritional status
Outcome Measures &
Length of Follow-up
Wound healing
Nutritional status
Infection
LOS
Evidence Level = I
Results
groups at week 10 vs. week 4 &
baseline; Arg-suppl group maintained
while isonitrogenous group
decreased lymphocyte proliferation
response
No significant change in NO between
or within group
No significant diff in BMI. body
weight, prealbumin, MNA between
groups at weeks 4 and 10
ONS (200-500 kcal, high protein,
consumed for 2 to 26 weeks)
associated with significantly lower
incidence (25% lower) of PrU in at
risk patients vs. routine care. Metaanalysis of all 5 RCTs showed
significantly lower incidence of PrU
development in at-risk patients vs.
routine care. Compared to standard
formulas, disease specific products
(high-protein) use exhibited trend
towards improved healing of existing
PrU.
Quality of evidence is
"poor", need additional
research to substantiate
findings
Indirect Evidence
Reference
Type of Study
Sample
Intervention(s)
de Luis DA, Izaola O,
Cuellar L, Terroba MC,
Aller R. Randomized
clinical trial with an enteral
arginine-enhanced formula
in early postsurgical head
and neck cancer patients.
Eur J Clin Nutr.
2004;58(11):1505-8.
Randomized clinical
trial
90 patients with oral
and laryngeal cancer
At surgery, patients were
randomly allocated to two
groups:
Group I: patients receiving
an arginine-enhanced
formula with arginine and
fiber (IMPACT, Novartis)
Group II: patients receiving
an isocaloric, isonitrogenous
formula with fiber enteral
formula (Isosource,
Novartis)
Investigate whether
postoperative
nutrition of head and
neck cancer patients
using an arginineenhanced formula
could improve
nutritional variables
as well as clinical
outcomes
55
Results
Limitations
No significant intergroup differences
in the trend of the three plasma
proteins (albumin, transferrin,
prealbumin) and lymphocytes
GI tolerance (diarrhea) was better in
group II than I (40% group I and 13%
group II: P<0.05)
Postop complications due to
infections were similar in both groups
(4% group I and 9% group II: ns).
Fistula (wound complication) was less
frequent in the enriched nutrition
group (5% group I and 11% group II:
P<0.05).
Wound infection was similar in both
groups.
Not PrU
Treatment Technical Report
Reference
Pompeo M.
Misconceptions about
protein requirements for
wound healing: results of a
prospective study. Ostomy
Wound Manage.
2007;53(8):30
Type of Study
Prospective,
descriptive study
Evaluate the
hypothesis that
wound patients
require higher levels
of protein than is
commonly
recommended & that
wound size and
severity affect
protein requirements
Sample
Tube fed patients with
& without wounds in 1
LTC (author's facility)
Wound group, n=93;
72.5 y; 60% female
Non-wound group,
n=57; 70.3 y; 54%
female
Intervention(s)
Outcome Measures &
Length of Follow-up
Wound group: 1.25 g
protein/kg/d
Non-wound group: 1 g
protein/kg/d
PUSH score
Protein status
56
Results
Length of postoperative stay was
better in group I than II.
47% of wound group vs. 32% in nonwound group had diabetes.
12% of wound group vs. 21% nonwound group had normal PreAlb
levels at admission.
LOS was longer for wound group vs.
non-wound group (36.9 vs. 29.7
days).
42% of wound group & 46% of nonwound group normalized &/or
increased PreAlb levels.
Feeding failure more common in
wound group
Patients improving protein status
received significantly (p=0.001)
higher dietary protein: 1.85 g/kg/d in
wound group & 1.47 g/kg/d in nonwound group.
Lower PUSH and total surface area on
admission seen in wound group that
did not improve protein status
Trend between higher wound burden
and max amount of protein provided
seen in patients whose PreAlb
improved.
Limitations
Descriptive study;
sampling
Limited information on
tube feed protocol
Treatment Technical Report
Table 4. Pain Assessment and Management
Direct Evidence
Reference
Type of Study
Sample
Intervention(s)
Abbas SQ. DiamorphineIntrasite dressings for painful
pressure ulcers. J Pain
Symptom Manage.
2004;28(6):532-4.
Retrospective
study
N=17, (9 females, 8
males)
Dressings applied with diamorphine
5-10 mg & Intrasite on a 4 X 4
dressing. Dressing changed every 1224 hours.
Inclusion: diagnosis of
incurable malignancy,
Grade 2+ pressure ulcers
Evidence Level = III
Mean age 68 years
(range 47-89 years).
Also in Table 15 Palliative
Care
Dallam L, Smyth C, Jackson
BS, Krinsky R, O'Dell C,
Rooney J, et al. Pressure ulcer
pain: assessment and
quantification... including
commentary by Gray M with
author response. J Wound
Ostomy Continence Nurs.
1995;22(5):211-8.
Prospective crosssectional study.
N=132 adults in tertiary
med center
Inclusion:
-1 or > Stage I-IV PrU,
Other:
78 (59%) female, 54
(41%) male, average age
71.4 (24-100).
68.9% had a sacral PrU
Group 1: n=44, Respondents, 1
interview
Group II: n=88, Nonrespondents
1 year data collection period, data
collected at 3 month intervals, charts
reviewed by researchers
Outcome Measures &
Length of Follow-up
Patients routinely recorded the
severity of their pain on a visual
analogue scale (VAS) ranging from 0
to 10 (0 = asymptomatic) on
admission and after 5 days. Clinical
details were recorded from their
notes. Data collected over 30
months.
Folstein Mini-Mental Status Exam,
Beck’s Depression Inventory, Faces
Pain Rating Scale, Visual Analog
Scale + chart review. Tools have
previously been reported to have
good reliability & validity.
Pain: “unpleasant sensory &
emotional experience with actual or
potential tissue damage.”
Evidence Level = III
Data collected at 3 month intervals,
but most only 1 time total.
Results
Limitations
2 patients died as a result
of progressive illness
within a week after
application. The
remaining 15 patients
showed an improvement
on VAS: 12/17 (70.5%)
improved by 4+ points.
Mean VAS improved from
9.4 to 4.6 after the
treatment (P = <0.02).
More research needs to
be done to address the
possibility of long-term
tolerance, intact skin
pain response, and the
right dose and type of
topical opioids.
Conclusion: diamorphineIntrasite gel may be an
effective treatment for
open pressure ulcers in
palliative care setting and
general medicine units.
Respondents: 41% denied
PrU pain & 68% reported
some degree of pain.
Most PrU were on sacrum
(70%), buttocks (24%) &
heels (14.4%).
Only 3 of 132 had received
analgesia for PrU pain in
preceding 4 hours, yet
many others had received
other types of pain meds
not for PrU pain.
Max pain score
significantly & inversely
correlated with age (r=.36, p<.02) & positively
correlated with max pain
intensity assessed by FRS
(r=.92, p<.01). Intensity of
pain localized to PrU sites
57
Non-respondent group
would have limited
ability to participate.
Primary conclusions can
be applied to
respondent group
rather than nonrespondent group.
Treatment Technical Report
Reference
de Laat EHEW, Scholte op
Reimer WJ, van Achterberg T.
Pressure ulcers: diagnostics
and interventions aimed at
wound-related complaints: a
review of the literature. J Clin
Nurs. 2005;14(4):464-72.
Type of Study
Systematic Review
Sample
13 publications r/t pain &
PrUs
Inclusion:
to ID state of the art on
pain, wound malodor or
exudates in pressure
ulcer patients
Intervention(s)
Outcome Measures &
Length of Follow-up
Aim: To describe the current scientific
evidence in the field of diagnostics
and treatment of pain, wound
malodor and exudate from pressure
ulcers and to give recommendations
for practice, based on the findings.
Systematic review
Methodological Quality: Literature
searched systematically for current
state of knowledge on the diagnosis
of pain, wound malodor and
exudates in patients with PrUs and
interventions used to treat these
problems. The first author screened
abstracts of all publications on the
basis of inclusion and exclusion
criteria. If any doubts, the whole
article was retrieved. If doubts
remained on the basis of the whole
article, another author was
consulted to decide about inclusion
or exclusion.
McGill Pain Questionnaire (MPQ):
58
Results
Limitations
significantly correlated
with generalized pain
intensity on VAS (r=.59,
p<.1) & generalized pain
intensity assessed by FRS
(r=.53, p<.1). Localized
VAS significantly
correlated with max PrU
stage (r=0.37, p<.01).
Those receiving analgesics
for PrU pain reported
significantly greater than
those not receiving
analgesics (p<0.05) &
those receiving narcotics
reported significantly
greater pain than those
not receiving narcotics
(.02). Patients with PrU
experience pain, & many
perceive it as severe, &
most did not receive
analgesics for PrU pain.
Stage IV PrU subjects had
greater pain than those
with lower stage PrU. Was
high degree of agreement
between FRS and VAS.
Is strong evidence to
support a positive effect
of topical (dia)morphine
for painful PrUs. Is some
evidence to support
positive effect of
benzydamine gel and
Eutectic Mixture of Local
Anaesthetic (EMLA)
cream. The reviewers
recommend to consider
both benzydamine gel and
EMLA as specific relieving
interventions in patients
with severe pressure
related pain, e.g., in
preparation of wound
Although pressure ulcer
prevention and wound
treatment are well
researched, little
evidence could be
retrieved with regard to
common symptoms
related to pressure
ulcers. Further research
should be conducted
into: psychometric
qualities of MPQ, VAS
and FRS in pressure
ulcer patients; methods
to operationalize the
diagnosis of wound
malodor; the effect of
Treatment Technical Report
Reference
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
This tool provides a description of
the qualities of pain, as well as
measurement of pain intensity. The
validity and reliability of the MPQ
have not been tested specifically in
pressure ulcer patients. However, a
great deal is known from other
more general pain literature.
Visual Analogue Scale (VAS): Proved
to be very suitable to measure pain
intensity and was also used to
measure pain in pressure ulcer
patients.
Faces Rating Scale (FRS): This tool
correspond well with the VAS in
patients with pressure ulcer pain.
The VAS strongly correlated with the
FRS (r=0.92; P < 0.01).
Pressure Sore Status Tool (PSST). It
consists of 13 Likert scaled item and
is used to describe the state of a
pressure ulcer. The interrater and
intra-rater reliability of the total
scale are high in Enterostomal
Therapy Nurses (r > 0.90; P < 0.01).
Face validity of the PSST has been
proven by experts.
59
Results
Limitations
debridement. From the
results on malodor and
exudates, the reviewers
cannot recommend a
specific dressing. In a
laboratory study, it is
proved that activated
charcoal is capable of
absorbing gas molecules
causing malodor. At
present, no studies are
available on the odorabsorbing capacity of
activated charcoal
dressing in PrU patients.
Exudate is a symptom of
impaired wound healing.
PSST is a valid and reliable
instrument for assessing
wound healing process. Is
a possible indication that
hydrocolloid positively
influences healing time
because the absorption of
exudates is more
effective.
The McGill PQ, VAS, and
FRS useful to assess PrU
pain.
topical analgesia (EMLA)
or benzydamines in
treatment of pressure
ulcer pain; the effect of
activated charcoal
dressing on pressure
ulcer malodor; the
effects of various types
of dressing on pressure
ulcer exudates and
alternative
interventions to
decrease pain; exudates
and wound malodor in
pressure ulcer patients.
Conclusion: Little sound
research has been done
on wound related
complaints IN PrU pts.
Authors recommend:
-using the MPQ, VAS or
FRS to diagnose PrU pain;
-using PSST for good
wound assessment/
evaluation; -using
(dia)morphine gel,
benzydamine-gel or EMLA
for pain relief;
-using hydrocolloid
dressing in exudating
Recommend using
MPQ, VAS & FRS to
diagnose PrU pain, using
MS gel, benzydamine
gel or EMLA for pain
relief.
Treatment Technical Report
Reference
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Results
Limitations
wounds.
Flock P. Pilot study to
determine the effectiveness
of diamorphine gel to control
pressure ulcer pain. J Pain
Symptom Manage.
2003;25(6):547-54.
Evidence Level = II
Randomized,
double-blind,
placebocontrolled
crossover pilot
trial. Patients
served as own
controls.
Inclusion: Grade II or III
painful PrU, inpatient for
1 or > weeks.
Exclusion: Grade I or IV
PrU, non-PrU. 12 on
sacral area, 1 heel, 62%
Stage II, mean size 9cm2.
Also in Table 15 Palliative
Care
Franks PJ Winterberg H,
Moffatt CJ. (2002). Healthrelated quality of life and
pressure ulceration
assessment inpatients treated
in the community. Wound
Rep Regen. 10:133-40.
N=13 patients from
inpatient hospice unit
admitted over 7 months
(mean age 77 years, 10
females).
N=7 who completed
study.
Case control study
design randomly
selected from
patients receiving
home care,
stratified by the
presence of a
pressure ulcer.
Patients were
interviewed.
N=175; 100 controls
without pressure ulcers;
75 patients with pressure
ulcers. Persons with
pressure ulcers were 55
women (73%), mean age
77.3 (16.1) years.
Pressure ulcer grades: 19
grade 1; 32 grade 2; 20
grade 3; 3 grade 4.
Pressure ulcer sites: 55%
sacrum; 35% heels; 13%
hips.
Random assignment to 1 of 2
treatment sequences: 3 days of
IntraSite gel followed by 3 days of
diamorphine gel, or vice versa.
IntraSite gel is ready-mixed HDG &
used as placebo. Diamorphine gel
(0.1% weight to weight mixture) was
mixed with IntraSite gel. Gels applied
1x/day & covered with standard
dressing. All patients had pressure
relieving cushions & mattresses &
encouraged to change positions
frequently. Pre-trial, PrU location, size
& stage were documented.
Prior to study entry PrU size,
location, stage was recorded. Pain
assessed before, 1, & 12 hours after
gel application by nursing staff
blinded to treatment sequence.
Patients rated pain as none, mild,
moderate, or over- whelming & this
translated to scores of 0=no pain to
4=overwhelming. Nurses checked
1x/day for skin irritation, pruritus,
constipation, nausea and/or
vomiting, drowsiness,
hallucinations, myoclonus jerking,
respiratory rate. Follow-up was 3
and 6 days.
To determine the impact of pressure
ulcers on health related quality of life
for patients living in the community
Short Form-36 (SF-36) and the
modified Barthel scale for
assessment of activities of daily
living. The SF-36 includes a bodily
pain score.
60
Seven patients completed
study (5 died, 1 became
confused). Pain scores
similar before IntraSite &
diamorphine gel
applications. Pain scores
improved significantly 1
(p=0.003) and 12 hours
(p=0.005) after
diamorphine gel
application compared with
placebo/baseline. Four
patients were pain- free
after 1 hour & 3 after 12
hours. No significant
difference in occurrence
of side effects between
groups at 1 or 12 hours.
No difference in systemic
pain med in the 2 groups.
Symptoms of opioid
toxicity similar in both
groups.
Bodily pain scores were
poorer for patients
without pressure ulcers
versus patients with
pressure ulcers when
controlling for age and
gender. Patients with
pressure ulcers had
significantly reduced selfcare and mobility and
poorer performance of
activities. Although there
were differences in the
two groups, the persons
with pressure ulcers were
similar to other patients
receiving community
nursing care. Many
patients with pressure
ulcers were not able to
Side effects not studied.
Small sample size (but
pilot study). High
attrition rate.
Treatment Technical Report
Reference
Freeman K, Smyth C, Dallam
L, Jackson B. Pain
measurement scales: a
comparison of the visual
analogue and faces rating
scales in measuring pressure
ulcer pain. J Wound Ostomy
Continence Nurs.
2001;28(6):290-6.
Type of Study
Secondary data
analyses as part of
a cross-sectional
study (reanalysis
of Dallam et al.
study)
Sample
N=44 respondents, N=88
non-respondents.
Inclusion:
-18 years or older,
-one or more stage I to IV
pressure ulcers, -some
ability to communicate
their pain experience.
Evidence Level = V
Intervention(s)
Outcome Measures &
Length of Follow-up
Pain measured when no treatment
being performed, including dressing
changes. Researcher either described
the location of the PrU or pointed to
the area of PrU & asked subject to
mark on VAS scale the amount of pain
felt or perceived at the PrU site. In
case subjects couldn’t comply with
VAS instructions, each subject then
shown FRS and told to mark the face
reflecting degree of pain felt at PrU
site.
The scatter-plot illustrated the
relationship between the FRS and
VAS did not appear to be linear.
Thus, nonlinear least squares
regression approach used with a
Gauss-Newton iterative procedure.
FRS used as independent variable
and VAS as a dependent variable.
Visual Analogue Scale (VAS) used
was a 0 to 100 mm horizontal line.
The Face Rating Scale (FRS) used
was 6 faces ordered horizontally
from smiling to crying, labeled 0 to 5
beneath each face, respectively
Jepson BA. Relieving the pain
of pressure sores [letter].
Lancet. 1992;339(8791):5034.
Descriptive
N=17 patients with 30
distinct PrUs.
No controls.
PrUs treated locally with 3%
benzydamine cream
Pressure ulcers
61
Cream applied, pain reports
documented 24 and 48 hours after
treatment
Results
give informed consent and
some were not able to
complete the SF-36.
The study demonstrated
the utility of the FRS in
hospitalized elderly
patients who have more
cognitive impairment and
sensory deficits relative to
a community population.
The study also established
that results obtained from
the FRS can be
transformed nonlinearly
to VAS with a high degree
of reliability.
After 24 hours of
treatment, 29 of 30 PrUs
were pain free with
complete relief achieved
in all 30 by 48 hours.
Limitations
-Secondary analysis order in which the
scales were
administered was not
random. Unable to
evaluate possible
carryover effect from
the VAS to FRS.
From FRS responses it
couldn’t be determined
whether subjects are
more influenced by the
faces or by the numeral
labels beneath them.
Subjects may not
consider the smiling
face labeled 0 in the FRS
to be equivalent to 0
(no pain) in the VAS, nor
may they consider the
crying face labeled 5 in
the FRS to be equivalent
to 100 (pain as bad as it
could be) in the VAS.
Although agreement
between the measures
of the 2 scales is
extremely high, the
relationship is complex.
Aside from nonlinear
parametric relationship,
variability increased
significantly with
increased perception of
pain, or equivalently,
reliability of the tools
good.
No control group.
Patient report of
pain/pain relief.
Treatment Technical Report
Reference
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Results
Limitations
Evidence Level = V
Prentice WM, Roth LJ, Kelly P.
Topical benzydamine cream
and the relief of pressure
pain. Palliat Med.
2004;18(6):520-4.
Randomized,
double-blind,
placebocontrolled trial
N=30 hospice inpatients
with cancer
Experimental Group:
n=17 randomly allocated
to benzydamine cream
Control group: n=13 to
placebo.
Mean age = 66.5 years
Difflan applied to unbroken skin,
either Stage I PrU or peri-wound skin,
but not directly to open wound.
11 point VAS & numeric pain scale
assessments done 24 hours prior to
& immediately following med
application, and at 2, 6, 12 & 24
hours after cream application.
Both tools considered to have good
reliability & validity & equivalent in
assessing pain.
Reduction in pain scores
occurred in both groups,
with Difflam cream
greater, it was not
significantly different
Small sample limited
ability to reach
statistical significance.
Data collection tool with 3 parts: 1)
demographic and clinical patient data
including characteristics of the ulcers;
2) pain characterization; 3) qualitative
and quantitative assessment of the
painful condition using a short version
of the McGill Pain Questionnaire
developed by Pimenta, Cruz and
Santos for Brazilian culture and a Pain
Intensity Numerical Rating Scale,
respectively.
Qualitative variables were compared
by the Fisher exact test and
Pearson’s chi-squared test.
Quantitative variables were
analyzed by the KolmogorovSmirnov Normality test, Student ttest, and ANOVA. P values <0.05 was
used for statistical significance.
The sample size is
relatively small, and the
study needs to be
repeated, maybe in a
multicentre and/or
prospective format, in
order to confirm the
results obtained and to
allow some
generalizations and
other correlation
investigation
PrU presence confirmed and medical
record review to determine their
characteristics
-data concerning pain was obtained
through interviews.
McGill Pain Questionnaire – used to
assess, discriminate and measure
dimensions of painful experience
(sensitive-discriminative, affectivemotivational, and cognitiveevaluative). The questionnaire
consists of 78 words divided into 20
categories and describes the
sensitive, affective, and cognitive
aspects of the experience of pain.
For this study, tool was translated &
adapted to Portuguese. Version
used contains 30 pain descriptors
divided into 3 categories (affective,
sensitive and evaluative) A choice
rate higher than 30% established as
the cut-off.
All patients reported PrU
ulcer pain, with 80%
reporting constant PrU
pain, not limited to a
particular time of day
(78.9%), & which did not
affect daily activities
besides movement in bed
and sitting up (80 and
75%, respectively). Mean
pain intensity was 5.80 +
2.93, characterizing a
moderate pain level. The
McGill Questionnaire
showed that sensitive
descriptive elements &
burning were most
frequently used to
describe PrU pain (56.57
and 35%, respectively).
Significant associations
were observed between
painful condition and
ethnic origin (p=0.034),
ethnic origin and impaired
appetite (p=0.014), age
and impaired walking
(p=0.002), and
preferential time of day
and number of ulcers
(p=0.013).
Evidence Level = I
Quirino J, Santos VLC,
Quednau TJP, Martins APF,
Lima P, Almeida MRM. Pain in
pressure ulcers. Wounds.
2003;15(12):381-9.
Evidence Level = IV
Exploratory,
descriptive and
cross-sectional
quantitative study
3 specialist palliative care
units.
N=20 patients from 3
acute care settings
Inclusion:
-18 years or >
-presence of pressure
ulcer
-cognitive &
communication abilities
to respond to a
questionnaire and
consent to participate in
the study.
Exclusion:
-inability to communicate
-inability to complete
study tools
NPUAP PrU staging performed
based on the NPUAP 4 stages.
The intensity of pain was measured
with a numerical rating scale
represented by a line numbered
62
Conclusion: This study
Treatment Technical Report
Reference
Roth RS, Lowery JC, Hamill JB.
Assessing persistent pain and
its relation to affective
distress, depressive
symptoms, and pain
catastrophizing in patients
with chronic wounds: a pilot
study. Am J Phys Med
Rehabil. 2004;83(11):827-34.
Type of Study
Prospective Crosssectional
Evidence Level = III
N=69 chronically ill male
patients with chronic
wounds from a VA Center
(mean age 59 [24-83
years]),
Intervention(s)
Outcome Measures &
Length of Follow-up
from 0 to 10 where 0=no pain and
10=worst possible pain
Patients followed for up to 6 visits.
All patients queried on 1st visit re:
wound pain, & if present, took series
of pain & other questionnaires.
McGill Pain Questionnaire, Numeric
Pain Rating Scale, Brief Symptom
Inventory, Center for Epidemiologic
Studies Depression Scale, & Coping
Strategies Questionnaire.
Pain measured at rest & at dressing
change using McGill Pain
questionnaire
MPQ used as quantitative measure
of PrU pain. Tool has 4 parts; tool
has good reliability & validity.
Severe Group had Stage
III-IV PrU (n=39),
Evidence Level = III
Szor JK, Bourguignon C.
Description of pressure ulcer
pain at rest and at dressing
change. J Wound Ostomy
Continence Nurs.
1999;26(3):115-20.
Sample
Descriptive,
comparative study
Other Group had Stage II
PrU, postop wounds,
venous or diabetic ulcer
(n=30).
Exclusion:
multiple wounds
N=32
Inclusion:
-Stage II-IV PrU
–in acute, home and
extended care settings.
Exclusion: Stage I PrU,
-non-English speaking &
cognitively intact to
sense and report pain.
Mean age 74.7 years (4795), =% M & F, Stage II =
12, III = 8, 12 = IV. NSD r/t
age & highest PrU stage.
63
Results
may contribute to
breaking the myth of the
absence of pain in
pressure ulcers,
permitting healthcare
workers to understand
this problem in order to
improve pain
management for patients
with pressure ulcers.
28% had wound pain
unrelated to dressing
change, average wound
duration 4.1 months
(range 1-15 months), near
SSD in that those with
Stage III-IV PrU to
experience >pain (35.9%)
than other (16.7%).
28 (87.5%) of patients
reported pain at dressing
change & 27 (84.4%)
experienced pain at rest,
& 4 (12.5%) reported no
pain. Of the 28 with pain,
75% rated it mild to
discomforting, 18% as
horrible or excruciating.
12 reported pain as
continuous, occurring at
rest & dressing change.
92% of subjects with Stage
II PrU reported pain, 100%
with Stage III had pain,
and 75% of Stage IV
reported pain. Only 2 (6%)
of subjects had received
pain med for their PrU
pain. Patients with Stage
Limitations
Small sample,
correlational design, no
causal direction can be
ascertained, sample not
homogenous with mix
of wounds.
No control for types of
dressings, use of
pressure reducing
products, pain meds,
etc. Small sample size.
Some subjects who
were acutely ill had
difficulty completing
MPQ.
Treatment Technical Report
Reference
Zeppetella G, Paul J, Ribeiro
MDC. Analgesic efficacy of
morphine applied topically to
painful ulcers. J Pain
Symptom Manage.
2003;25(6):555-8.
Type of Study
Randomized,
double-blind,
placebocontrolled,
crossover pilot
study
Evidence Level = I
Sample
5 hospice patients with
advanced cancer &
painful sacral PrU from
4.5 – 14 cm2, PrU could
not be infected or
covered by necrotic
tissue & suitable for
1x/day Intrasite Gel
application, & receiving a
stable analgesic regime
for at least 48 hours.
Intervention(s)
Outcome Measures &
Length of Follow-up
Treated for 2 days with either 10mg
MSO4 or placebo applied topically to
PrU in am of day 1 & covered with
Tegaderm, 2 day wash out period,
then crossed over for 2 days of
alternate treatment. Rescue analgesia
available in usual way.
VAS used 2x/day, am & pm, to rate
analgesia & to document any local
or systemic side effects
Outcome Measures &
Length of Follow-up
Three main themes with associated
sub-themes.
Results
II, III & IV PrU experience
pain which is often severe
& constant. The number
of word descriptors used
to describe pain  directly
in relation to PrU Stage.
Patients with Stage III-IV
reported more constant
pain, Stage II more
transient pain. “Individual
pain assessment should be
included as a standard
part of the initial
assessment of PrUs, &
therefore be assessed on a
regular basis, not just at
dressing change or other
manipulations of the
wound.” P. 119.
All patients reported
lower VAS scores with
MSO4 compared to
placebo & no local or
systemic adverse effects
attributable to MSO4 (47
v. 15). NSD inpatients’ use
of rescue analgesics
during 2 treatment arms.
Study suggests MS added
topically is effective in
producing local analgesia,
is well tolerated, & no
negative effects.
Limitations
Small sample, only 1
MSO4 treatment
Indirect Evidence
Reference
Type of Study
Sample
Intervention(s)
Bale S, Dealey C, Defloor T,
Hopkins A, Worboys F. The
experience of living with a
pressure ulcer. Nurs Times.
2007;103(15):42-3.
Qualitative pilot
study, Heideggarian
phenomenology
with interpretative
phenomenological
Eight older adults from
4 centres, 3 in England
& 1 in Belgium.
Inclusion criteria
included older adults
Unstructured interviews which
acknowledged the contribution of
both the participant & researcher.
64
Results
Limitations
Three main themes of
endless pain, a restricted
lifestyle, & coping with
the PrU. Pain was
constant & severe feature
Researchers felt design
fitting to multiple
settings. Limited to older
adults and limited
number of participants.
Treatment Technical Report
Reference
Type of Study
Sample
analysis.
with grade 3 or 4 PrU;
exclusion criteria were
spinal cord injury &
inability to provide
informed consent. Age
range 68-101.
Participants had other
co-morbidities.
Meta-analysis,
6 reviews (total n=317
patients), 3 in 1999
review and 3 in 2003
review.
Also in Table 15 Palliative
Care
Briggs M, Nelson EA. Topical
agents or dressings for pain in
venous leg ulcers. Cochrane
Database Syst Rev. 2007(4).
Intervention(s)
Outcome Measures &
Length of Follow-up
No trials for persistent pain. 3 studies
in 1999 review & 3 in 2002 review
considered sufficiently similar to pool
65
Results
Limitations
& analgesia not always
effective. Pain prevented
proper rehab in some.
Cycle of pain, not pain
itself was endless.
Severity of pain not
always recognized by MD.
Pain  by repositioning
(conflicts with best
evidence on frequent
repositioning), lie still,
pain relieving equipment.
Pain was restricting
feature with significant
impact on life & feelings
re: self. Worried,
depressed feeling
burdensome, inadequate
& sense of
powerlessness. Disliked
their dependence on
others & change from
former life. Odor was
impacting them. Social
life & general activity
restrictions were the
worst part. Impact on
significant others &
family. PrU also caused
extended hospital stay.
Coping with PrU & the
consequences facilitated
thru comparing self with
others “who had it
worse.” Acceptance of
situation with some
fatalism, & positive
thinking seen as part of
getting on with their
lives.
Statistically sig  in
debridement pain scores
with EMLA 5% cream,
EMLA associated with 
in pain scores of 26 mm
May not be generalizable
worldwide.
Treatment Technical Report
Reference
Davis MDP. Lidocaine patch
helpful in managing the
chronic pain of leg ulceration.
J Am Acad Dermatol.
2003;49(5):964.
Flanagan M, Vogensen H,
Haase L. Case series
investigating the experience
of pain in patients with
chronic venous leg ulcers
treated with a foam dressing
releasing ibuprofen. World
Wide Wounds. 2006:1-18.
Type of Study
Descriptive
Case series
Sample
Inclusion: persistent
pain, venous leg ulcer,
appropriate statistical
analyses.
11 patients with painful
leg ulcers
N=10, 5/5 M/F.
Inclusion: painful
chronic venous leg ulcer
(CVLU) ABPI 0.8 or >,
mod to highly exuding,
VAS pain score 3 or >,
ulcer >2 cm2 & periwound >2 cm from
wound, over 18 years
Fox C. Living with a pressure
ulcer: a descriptive study of
patients' experiences. Br J
Community Nurs. 2002;7(6
Suppl):10.
Descriptive
phenomenological
Freedman G, Cean C, Duron
Preliminary
Exclusion: s/s infection,
steroid treatment, DM,
Lupus, vasculitis,
pregnant or breast
feeding, allergy to
ibuprofen or ASA, need
to wear compression
bandage
N=5, 31-64 years old, 4
men, 1 woman. PrU
duration 4-36 months;
participants lived in the
community
N=32 consecutive
Intervention(s)
Outcome Measures &
Length of Follow-up
Results
Limitations
on 100 mm scale.
All patients treated with 5% lidocaine
patch for pain
Subjects treated with foam ibuprofen
dressing & appropriate compression
bandaging for 6 dressing changes,
followed by treatment with non-pain
relieving foam (Biatain) in non-active
treatment period where dressings
were changed every 2-3 days for 2
weeks.
Pain measured via VAS 24 hours
before study & immediately before
removal of 6th & final dressing 1
week after removal of active
dressing (end of 1st 6 weeks).
Subjects evaluated pain 1 week
after removal of ibuprofen dressing.
Qualitative data also collected.
End points – change in wound pain
intensity & HrQoL
Leg ulcer Assess form: standard
data including size, photo, etc
Qualitative interviews @ start of
study & end, diaries maintained thru
out
Interview at beginning & end of
study, diary thru out.
Semi-structured interview to explore
& describe experiences of patients
living with a PrU.
Patient assigned own pain rating &
66
Pain assessed via Visual Analogue
Effect of EMLA on healing
remains unknown.
Pain improved on
average 51% on a pain
alleviation scale ranging
from 0% (no alleviation)
to 100% (full alleviation).
Sig  in mean pain scores
between baseline & final
dressing (85 + 6 v 29 +30,
p<.0003), & sig  in VAS
between final dressing &
follow-up visit (29+30 v
14.8, P<.03).
All experienced severe
unrelenting persistent
pain punctuated by
episodes of intense pain.
9 of 10 patients reported
pain reduction within 30
min – 4hrs after
treatment.
Three main themes &
sub-themes emerged. 1.
Physical (pain, exudates,
loss of independence), 2.
Psychological (emotional
factors, worry about
healing, relationships,
body image), 3. Social
(social isolation). Pain
was dominant physical
factor & recurring themes
throughout the interview.
Pain varied in level of
intensity & disturbed
sleep. Deep ulcers were
painful.
Visual Analogue Scale
Measurement of
patient’s pain is
subjective & subject to
interpretation &
influence of other
uncontrolled variables.
Uni-dimensional rating
scales, e.g., VAS, fail to
reflect multiple
dimensions of pain. Pain
rating differs with time of
day, stress, season, and
mood.
18 of the 32 patients
Treatment Technical Report
Reference
Type of Study
Sample
Intervention(s)
V, Tarnovskaya A, Brem H.
Pathogenesis and treatment
of pain in patients with
chronic wounds. Surg Tech
Int. 2003;11:168-79.
exploratory study
patients with chronic
wounds
Modified Functional Independence
Measurement (MFIM). Person
assessing patient made assessment
based on patient completed forms.
Outcome Measures &
Length of Follow-up
Score (VAS) of 0 to 10, with 0
signifying no pain and 10 signifying
the worst pain. Two other variables
included were: the patient’s
(MFIM) and wound surface area.
Results
Limitations
(VAS)
experienced pain. On a
scale of 0-10, the average
pain experience by these
patients was 5.08. Pain is
decreased when an
integrated wound
management team is
involved in treatment,
based on results
tabulated from the forms
of patients with multiple
pain scores. The
decrease in pain was
generally correlated with
a decrease in wound
surface area and an
increase in the patient’s
MFIM. The correlation
implies that pain
management facilitates
healing of the wound and
healing results in less
pain. Pain assessment
form is unbiased,
accurate method that
should be used to
measure change of pain
in patients with chronic
wounds. Study had a
small sample size.
Subject’s age not
mentioned.
Modified Functional
Independence
Measurement (MFIM) –
indicates a patient’s
ability to perform basic
self-care and locomotion,
and is measured on a
scale of 0-70, with 70
signifying complete
independence and 0
signifying complete
dependence.
Note: MFIM form and
Pain Assessment form are
included in the article.
Gottrup F, Jørgensen B,
Karlsmark T, Sibbald RG,
Rimdeika R, Harding K, et al.
Less pain with Biatain-Ibu:
initial findings from a
randomised, controlled,
double-blind clinical
investigation on painful
venous leg ulcers. Int Wound
J. 2007;4 Suppl 1:24-34.
Double-blind RCT
N=122
Ibuprofen Group=62
Control=70
Both had foam dressings, but 1
impregnated with ibuprofen.
Venous ulcers
67
3 investigation periods: days 1-5, 642, 43-47. Subjects randomized to
treatment group, days 1-5 & 6-42
patients randomized 1:1 to
treatment group. Days 43-47
treatment blinded only to patients.
All crossed over & treatment with
comparative dressing. Persistent
pain & dressing change related pain
assessed days 1-5 & 43-47.
Persistent pain rated bid between
dressing changes using 5 point VRS
& pain intensity on 11-point NBS
Patients in ibuprofen
group experienced
significantly > relief from
persistent pain (p=.0003)
days 1-5; wound pain
intensity significantly  in
ibuprofen group days 1-5
(p<.0003), 6.8 baseline to
4.1 (40%).
Dressing change pain
intensity  in ibuprofen
group on introduction of
Treatment Technical Report
Reference
Type of Study
Hampton S. Chronic pain in
wounds: a report on 11 case
studies. Nurs Times.
2007;103(15):48-50.
Case series
Hansson C, Holm J, Lillieborg
S, Syrén A. Repeated
treatment with
lidocaine/prilocaine cream
(EMLA) as a topical
anaesthetic for the cleansing
of venous leg ulcers. A
controlled study. Acta Derm
Venereol. 1993;73(3):231-3.
Randomized,
prospective
parallel-group
study.
Hopkins A, Dealey C, Bale S,
Defloor T, Worboys F. Patient
stories of living with a
pressure ulcer. J Adv Nurs.
2006;56(4):345-53.
Heideggerian
phenomenology.
Inclusion criteria:
>65 years, Stage IIIIV PrU > month,
able to consent.
Sample
11 subjects, 45-87 years
(average 74)
Intervention(s)
Outcome Measures &
Length of Follow-up
scale. Pain at dressing change rated
on NBS on days 2,5,45, & 47.
Pain intensity assessed over 10 days
following application of ibuprofen
impregnated dressing.
Pain intensity assessed on 10cm
VAS scale
EMLA group: 8 consecutive
treatments, 2-9 days apart, for 30
min each, then ulcer bed cleansed 10
min after cream removed;
Control group: 8 weekly treatments.
After cream removed, ulcer
examined for edema, redness,
paleness or local reaction & if
present, severity rated as none,
slight, moderate, or severe. VAS
rating for ulcer cleansing done
immediately following & 4 hours
later. 1st & last visits, culture done,
ulcer measured, & granulation &
slough tissue assessed.
Unstructured interviews, use of
probes
Central analysis with identification
of themes & verification by
researchers.
Inclusion: adults,
chronic wounds
N=43
EMLA Group=22
Control Group=21
Inclusion: venous leg
ulcer, systolic ankle
pressure >80mmHg
Exclusion: ulcers <1cm2,
or >50cm2 , history of
sensitivity to local
amide type anesthetics,
treatment with EMLA
cream during previous
month, ongoing local
antibiotic or proteolytic
enzyme treatments.
N=8 (7 from UK & 1
from Belgium) from 4
centers & with 4 data
collectors
68
Results
non-ibuprofen dressing
(days 43-47). Sig diff pain
intensity (p<.05) at
dressing removal for
ibuprofen group from
baseline NBS values of
0.3 to 0.9 (300%)
compared to constant
levels in non-ibuprofen
group with average NBS
of 2.0 baseline. No diff in
dressing change pain
days 1-5.
On 1st day, lowest scores
were 1-10 with all
Patients having overall
score of 75 (average 6.8).
Overall score 29 on day
10. Level of pain reduced
23% overall following 1st
application & by 61% on
final application of
dressing.
Treatment with EMLA
cream significantly  pain
from cleansing &
frequency of postcleansing pain. Analgesic
effect remained
unchanged with
successive treatments.
NSSD in local reactions or
adverse effects on
granulation tissue, ulcer
area or bacterial flora
between groups.
3 themes; endless pain,
restricted life, coping
with PrU. Endless pain
had 4 sub-themes of
constant presence,
keeping still, equipment
Limitations
No statistical analysis
used.
Treatment times
insufficient for healing to
occur.
Multiple interviewers;
translation of stories;
obtaining sample due to
age limitation presence
of comorbidities; many
had had flap repair;
Treatment Technical Report
Reference
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Exclusion criteria:
SCI
Jorgensen B, Friis GJ, Gottrup
F. Pain and quality of life for
patients with venous leg
ulcers: proof of concept of
the efficacy of BIATAIN-Ibu, a
new pain reducing wound
dressing. Wound Repair
Regen. 2006;14(3):233-9.
Krajnik M, Zylicz Z, Finlay I,
Luczak J, van Sorge AA.
Potential uses of topical
opioids in palliative care-report of 6 cases. Pain.
1999;80(1-2):121-5.
Also in Table 15 Palliative
Care
Single-blinded cross
over study
N=10
Inclusion: adult, painful
venous leg ulcer >8
week duration, received
compression therapy
for at least 4 week prior
to study
Case review
Pre-treatment period with 2 placebo
dressings (Biatain-pre),
Test treatment period with 5 active
foam dressings containing ibuprofen
Followed 3 weeks. Evaluated q2-3 d,
NBS used to rate pain before &
during dressing change, & 15” after
dressing change.
Washout period with 2 placebo foam
dressings.
Exclusion: presence of
clinical infection or
cellulitis of peri-ulcer
skin, disease that
interferes with healing.
All wore short stretch compression
hose.
3 week study period
Six cases of patients
treated with topical
opioids. Cutaneous pain
due to tumor
infiltration, skin ulcers
of malignant & nonmalignant origin, severe
oral mucositis, pain d/t
knee arthrosis, & severe
tenesmoid pain.
Case review. Patients received 0.1%
morphine gel
69
Pain relief
Results
Limitations
pain, treatment pain.
Underlying current of
sense of powerlessness &
a “never ending story.”
Mean age 82 years, 66%
females.
Biatain-ibu foam dressing
correlated with  in pain
intensity scores from 7 to
2.5. Wearing a Biatain-ibu
dressing before dressing
change reduced pain
during dressing change &
after new dressing
applied, for chronic &
temporary pain. No local
SE of using Biatain-ibu
dressing
Patient. A: (89 y/o) with
3x7cm painful & inflamed
subq upper tibial
infiltrate. Pain 4-8 preand 0-2 post. Patient B:
(56 year old) cutaneous
pain with sacral &
colostomy infiltration.
Pain pre4-10 and post- 1
until last week of life it
was occasionally 6.
Patient C: (71 y/o) severe
oral mucositis, pain pre10 & post- 2-4. Patient D:
(71 y/o) painful necrotic
leg ulcers, pain pre- 10 &
post- 4. Patient E: (69
y/o) with cancer of
larynx, pain pre- 9 & post2-4. Patient. F: (62 y/o)
vulvar cancer, pain pre- 6
& post- 2. Opioid
receptors are inactive in
non-inflamed tissue.
After onset of
inflammation, opioid
Observation periods
were short. Application
of gel to open wound is
difficult, especially with
much exudates, & much
of drug may be flushed
away. Need to identify
how morphine absorbed
through healthy skin, as
is poor thru intact
epidermis, but when
epidermis removed,
bioavailability is 75%. Is
morphine absorbed
systemically rather than
locally?
Treatment Technical Report
Reference
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Heideggerian
hermeneutical
phenomenology
with PrUs
N=42 nurses providing
care to patients with
PrUs
Nurses asked to write brief
description about experiences with
patients with PrU pain.
Langemo DK, Melland H,
Hanson D, Olson B, Hunter S.
The lived experience of
having a pressure ulcer: a
qualitative analysis. Adv Skin
Wound Care. 2000;13(5):22535.
Spiegelberg’s
phenomenological
method –
descriptive,
qualitative
N=8, Non-probability,
purposive sample, 4
with PrU & 4 with
previous PrU (Stage IIIV). Four had SCI & 5
had surgical flap
reconstruction; 2 had
MS, 1 was bipolar,
alcoholic, & 1
degenerative
neuromuscular
disorder. Males=7,
female=1, mean age
35.7 year, range 27-52
year. 6 of 8 had
multiple PrU, all 4
current Patients with
PrU were Stage IV
Unstructured, face to face, audiotaped interview. Field notes taken.
Each person asked to respond to
“Please describe your experience of
having a PrU. Share all the thoughts,
perceptions, & feelings you can recall
until you have no more to say about
this experience.” Used relevant
probes to elicit additional data.
Demographic info also obtained.
Interviews transcribed verbatim,
accuracy verified. 3 researchers
ensured content validity. Colaizzi’s
content analysis established via
reading transcriptions, extracting
significant statements & phrases
directly related to lived experience,
meaning formulated from
significant statements & phrases,
formulated meanings organized into
clusters of themes, & researchers
integrated results into exhaustive
description of the lived experience.
Randomized,
double-blind,
placebo-controlled
study
N=69;
EMLA group=36
Placebo Group=33
All patients received oral
dextropropoxyphene 30mg &
acetominophen 400mg 1 hour before
debridement. EMLA group received
VAS 10-cm scale
Lok C, Paul C, Amblard P,
Bessis D, Debure C, Faivre B,
et al. EMLA cream as a topical
anesthetic for the repeated
70
Limitations
receptors become
activated within hours.
Morphine & diamorphine
appear to do equally well.
Three consecutive
patterns and 8 themes
identified.
Krasner D. Using a gentler
hand: reflections on patients
with pressure ulcers who
experience pain.
Ostomy/Wound
Management. 1996;42(3):20.
Also in Table 15 Palliative
Care
Results
Length of follow-up 15 treatment, if
>15 needed, patient d/c from study.
7 themes emerged:
perceived etiology of PrU,
life impact & changes
(physical, financial &
social), psycho-spiritual
impact (body image
changes, struggle with
stereotypes,
desire/struggle for
control & independence,
spiritual impact), extreme
painfulness with PrU
(pain Intensity &
duration, analgesic use),
need for knowledge &
understanding
(knowledge of
prevention, physiologic
processes & lack of
knowledge), need for &
effect of numerous
stressful treatments (selfcare, treatment regimens
& multiple surgeries,
complications, length of
healing time), & grieving
process (denial,
depression, anger,
bargaining, acceptance).
NSD between groups on
demographics. EMLA
cream sig  VAS pain
scores for debridement
Limited to Caucasians,
young or middle age, in
Midwest area of US.
Need replication in other
ethnic groups & urban
areas. Not followed
longitudinally.
Study at multiple centers,
so can be difficulty
controlling for
methodology &
Treatment Technical Report
Reference
Type of Study
mechanical debridement of
venous leg ulcers: a doubleblind, placebo-controlled
study. J Am Acad Dermatol.
1999;40(2 Pt 1):208-13.
Munter KC, Beele H, Russell L,
Crespi A, Gröchenig E, Basse
P, et al. Effect of a sustained
silver-releasing dressing on
ulcers with delayed healing:
the CONTOP study. J Wound
Care. 2006;15(5):199-206.
Comparative open
prospective parallel
& blockrandomized study.
Total 18 month
study period.
Sample
Intervention(s)
Inclusion: venous ulcer
(5-50 cm2 ) with necrosis
on 50% or > of ulcer
area, needs
debridement at least 3x
during 1st week, no
previous use of EMLA
cream
thick layer of EMLA cream, covered
with plastic wrap for 30-45”, cream
removed & debridement begun
within 10”. Placebo cream for control
group. Post debridement wound
covered with Vaseline gauze. MD
determined frequency of
debridement after week 1, max of 15
debridements allowed. Elastic
compression bandage standard
treatment at 6 centers & for some
patients at 2 other centers. Bandages
& dressings removed qd to assess
need for debridement.
N=619
Inclusion: 18 or >, not
pregnant or lactating,
chronic wound with
delayed healing & modhigh exudates
Exclusion: depth <0.5cm
Also in Table 15 Palliative
Care & Table 9 Dressings
Rastinehad D. Pressure ulcer
pain. J Wound Ostomy
Continence Nurs.
2006;33(3):252-6.
Patients Randomized to either silver
foam or LBP & followed weekly for 4
weeks. At q visit wound assessment
made & dressing change.
HRQoL at 1st & final visits done.
Outcome Measures &
Length of Follow-up
Ulcer CLEAN if 75% or > free from
necrotic & fibrinous tissue & crusts.
Size measured via tracing. Pa
N=10, Purposeful
sampling of acute care
patients with a PrU, 7
female & 3 male, 30-90
years of age. 8 had preexisting PrU & 2 PrU
developed in hospital.
Pain measured on 10-pt scale,
measured at q dressing change
Endpoints  in ulcer size, exudates, or
change in wound bed composition,
HRQoL, cost effectiveness
Multiple taped interviews done along
with field notes and transcripts of
interviews generated. Data collection
over 8 months & analysis over 16
months
71
Limitations
by  50% (p=.003). EMLA
cream produced
satisfactory analgesia for
mechanical debridement
for up to 15 repeated
sessions.
assessments.
EMLA group had sig 
debridements until clean
(11.5 v >15) & this can
have +$$ savings.
8% were PrUs.
Phenomenological,
qualitative study
Results
Semi-structured interviews using
decision trail, interviews taped &
transcribed, field notes done to
support data analysis & theme
identification. Analysis reviewed by
10 researchers & 2 WOCN nurses.
Number of patients who
interrupted debridement
d/t pain sig  in EMLA
group (41.7%) v placebo
group (75.8%).
Median rating of pain at
dressing changes  in
silver foam than LBP
group (p<.0001 week 1,
p<.0011, week 2) & in
between dressing
changes.
Silver foam group had >
in wound area (58.5% v
33.3%), less maceration,
better exudates
management, & faster 
in odor than LBP group.
Most had Stage II PrU, 2
had Stage III & 1 had
Stage IV, with majority on
sacrum, with 1 on heel &
1 scapula. 22 themes and
1 constitutive pattern
identified. Multiple terms
used to describe pain
Majority of patients with
a PrU experience pain of
varying intensities, many
severe, which was
consistent with Dallam,
LBP included a multitude
of dressings, thus large
sample required to offset
this.
Limited to 10 subjects.
Treatment Technical Report
Reference
Sibbald RG, Coutts P,
Fierheller M, Woo K. A pilot
(real-life) randomised clinical
evaluation of a pain-relieving
foam dressing: (ibuprofenfoam versus local best
practice). Int Wound J. 2007;4
Suppl 1:16-23.
Type of Study
Open comparative
prospective blockrandomized design.
Pilot study.
Vast majority
venous ulcers.
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
N=24
Randomized to 1 week trial.
Inclusion: adults with
chronic pain with modhighly exudating leg
ulcers; minimal wound
size 0.5x0.5 cm & max
would have to be
covered by 10x10 cm
dressing. Able to
comprehend & rate
pain & do pain diary. All
pain & other meds to
be unchanged for 1
week of study.
Ibuprofen Group (N=12) received
foam dressing with ibuprofen,
Pain intensity measured bid on 10point NBS (Numeric Box Scale), pain
relief on 5-point VRS & diary with
am & pm recordings.
LBP Group (N=12) received moist
dressing with active anti-microbial &
anti-inflammatory components
Baseline & final ulcer assessments
done. Patients maintained regular
concomitant meds during study.
Followed for 1 week
Results
Langemo, & Szor.
Emotions of frustration,
depression, anger & rage
also reported. The pain
experience from a PrU
permeates their
existence.
For ibuprofen group,
additive am scores sig 
(p=.04) & pm scores sig 
(p=.02), sig correlation
between am & pm scores
(r=.85, p<.0001), & with
pooled am & pm scores
(p=.0217). Sig  in acute
wound pain intensity
after last dressing
removal (p=.04).
Sig  in ulcer area in
ibuprofen group (p=0.05)
& ibuprofen group also
had > granulation tissue.
Limitations
No blinding, & subjects &
researchers aware
dressing contained active
analgesic. Patient pain
assessment is subjective.
Pilot study.
Exclusion: known
contraindication or
allergy to ibuprofen or
NSAID, females
pregnant or lactating,
ulcer down to tendon,
muscle or bone, or
symptoms of bacterial
burden.
Spilsbury K, Nelson A, Cullum
N, Iglesias C, Nixon J, Mason
S. Pressure ulcers and their
treatment and effects on
quality of life: hospital
inpatient perspectives. J Adv
Nurs. 2007;57(5):494-504.
Qualitative semistructured
interviews
Inclusion criteria:
Exclusion criteria:
Ibuprofen Group=12
LBP Group=12
Purposive sample, N=23
hospitalized patients
(M=5, F=18), 33-92
years (median 78
years). Highest PrU
locations heel &
sacrum. PrU stages II-V.
Semi-structured interview; verified
meaning and understanding
throughout interviews; interviews
recorded & transcribed.
72
Identification of themes & subthemes
91% (21/23) said PrU &
treatment affected lives
emotionally, physically,
mentally & socially.
Dependent on others to
treat, manage, and care
for PrU. Pain, discomfort
& distress of PrU not
acknowledged by nursing
staff. 7 patients blamed
Impossible to separate
effect of PrU from
chronic condition.
Treatment Technical Report
Reference
Vanscheidt W, Münter KC,
Klövekorn W, Vin F, Gauthier
J, Ukat A. A prospective study
on the use of a non-adhesive
gelling foam dressing on
exuding legs ulcers. J Wound
Care. 2007;16(6):261-5.
Non-adhesive gel foam
dressing, Versiva
Type of Study
Pre- Post,
Prospective open
label comparative
study.
Sample
N=46
50% male, 50% female
Inclusion: heavily
exudating leg ulcer
Exclusion: sensitivity to
GFD-N, history poor
adherence, arterial
ulcer, required wound
filler on enrollment
Intervention(s)
Outcome Measures &
Length of Follow-up
Baseline data, pain level, peri-ulcer
skin info collected. Wound cleaned,
debrided & measured. Subjects
treatment with non-adhesive gelling
foam dressing & compression for 28
days & pain assessed. At least weekly
clinic visits.
Outcome measure=pain intensity
rated on VAS 10-point scale.
Length of follow-up 28 days or
withdrawal from study, whichever
came 1st.
Primary endpoint safety, 2nd
endpoint measures of dressing
performance, exudates
management, ease of use &
pain/comfort.
Also in Table 15 Palliative
Care
73
Results
health care prof for
getting PrU, 8 blamed it
on comorbidities, , 3 on
poor hygiene practices or
lack of knowledge. 91%
had PrU pain, & 2 who
didn’t either had neuro
condition or were
unaware of PrU. PrU
associated with pain,
fluid leakage & smell,
discomfort, & mobility
difficulties.
Mean pain VAS intensity
rating  >50% for 1st clinic
dressing change
compared to pre-study
(4.7 v 23, p<.001) & on
removal (3.9 v 1.7,
p<.001). Peri-wound skin
condition better for 31%
(p=0.006). GFD-N
dressing associated with
SSD  in ulcer pain with
dressing in place & during
removal. Of 46 subjects,
11% healed the ulcer &
78% improved in 4 or <
weeks.
GFD-N was safe, effective
& convenient for wound
healing, exudates
management,
pain/comfort & ease of
use.
Limitations
Subjects used as own
control, no RCT, no true
control group.
Treatment Technical Report
Table 5. Support Surfaces for Treatment of Pressure Ulcers
Direct Evidence - Adult
References
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Interface pressure (IP)
measurement in sitting position
Attard J, Rithalia SV, Kulkarni
J. Pressure relief
characteristics in alternating
pressure air cushions.
Prosthet Orthot Int.
1997;21(3):229-33.
Evaluation of 4
alternating pressure
air cushions (APAC).
10 healthy volunteers
None
Bell J. The role of pressureredistributing equipment in
the prevention and
management of pressure
ulcers. J Wound Care.
2005;14(4):185-8.
Review of published
papers on pressure
reducing and
pressure relieving
mattresses
Defloor T, Grypdonck MH. Do
pressure relief cushions really
relieve pressure? West J Nurs
Res. 2000;22(3):335-50.
Evaluation of 29
seating cushions
and sheepskin.
20 healthy volunteers
None
Interface pressure (IP)
measurement in sitting position
Makhsous M, Rowles DM,
Rymer WZ, Bankard J, Nam
EK, Chen D, et al. Periodically
relieving ischial sitting load to
decrease the risk of pressure
ulcers. Arch Phys Med
Rehabil. 2007;88(7):862-70.
Repeated measures
of 2 sitting push-up
protocol
20 normal, 20
paraplegic and 20
tetraplegic subjects
1 hour protocol with Alternate &
Normal plus push-up
Alternate was 10 min normal sit & 10
min sit without ischial support
Normal plus was 20 min normal sit
followed by pushup or lift of subjects
Interface pressure on seat & back
rests
Nixon J, Nelson EA, Cranny G,
Iglesias CP, Hawkins K, Cullum
NA, et al. Pressure relieving
support surfaces: a
randomised evaluation.
Health Technol Assess.
2006;10(22):iii.
Multicenter RCT,
open, fixed sample,
parallel-group trial
11 hospital based
research centers in UK
Alternating pressure mattress (n=982)
or overlay (n = 989)
Development of new PrU – stage 2
or greater; healing of existing PrU
Results
Limitations
Some of the devices did
not relieve pressures
below 20mmHg even
with complete deflation
of air cells.
Healthy subjects. No
patients with PrUs. No
follow-up.
Article deals with
evolution of pressure
redistributing surfaces
and interface pressure
measurement, but not
PrU directly.
74
Gel cushions and
sheepskin have no
pressure reducing effect
Some types of foam
cushions decrease while
others increase IP. Air
cushions had the lowest
IP.
Significantly lower
average pressure over
buttocks with alternate
sitting protocol
Healthy subjects. No
patients with PrUs. No
follow-up.
No statistically significant
difference in proportions
of patient developing
PrU, healing time.
Reduced LOS on mattress
resulted in some cost
savings
No length of follow-up
given.
1 hour study duration
No follow-up
No gender
differentiation
Lack of BMI control
Unrelated to PrU
outcome
Treatment Technical Report
References
Type of Study
Sample
Intervention(s)
Ochs RF, Horn SD, van Rijswijk
L, Pietsch C, Smout RJ.
Comparison of air-fluidized
therapy with other support
surfaces used to treat
pressure ulcers in nursing
home residents. Ostomy
Wound Manage.
2005;51(2):38-68.
Retrospective
664 NH residents
3 mattress groups
Ooka M, Kemp MG, McMyn
R, Shott S. Evaluation of three
types of support surfaces for
preventing pressure ulcers in
patients in a surgical intensive
care unit. J Wound Ostomy
Continence Nurs.
1995;22(6):271-9.
New product
evaluation, 3month study period
110 patients in SICU
Purvis K et al. How the use of
electric profiling beds can
reduce the prevalence of
pressure ulcers. Prof Nurse.
2005;20(8):46-8.
18-week pilot study
reviewing hospital
acquired PrU
prevalence and
appropriateness of
equipment
selection
Randomized
prospective cohort
study (2 studies)
Unblinded,
randomized,
prospective trial
Rosenthal MJ, Felton RM,
Nastasi AE, Naliboff BD,
Harker J, Navach JH. Healing
of advanced pressure ulcers
by a generic total contact
seat: 2 randomized
comparisons with low air loss
bed treatments. Arch Phys
Med Rehabil.
2003;84(12):1733-42.
Russell LJ, Reynolds TM, Park
C, Rithalia S, Gonsalkorale M,
Birch J, et al. Randomized
clinical trial comparing 2
support surfaces: results of
the Prevention of Pressure
Ulcers Study. Adv Skin Wound
Outcome Measures &
Length of Follow-up
Healing rates
Results
Patients placed on either a static
foam or dynamic surfaces
Braden scale, PrU occurrence
3 patients on each of the
3 support surfaces
acquired 17 PrUs. No
difference between
support surfaces
Limited follow-up
Patients in medical and
surgical wards with a
Braden score of 18 or
less
Hospital wide supply of 564 electric
profiling beds, seating and dynamic
mattress systems for high risk pts.
Improved patient education,
repositioning, nutritional needs and
skin care.
PrU prevalence rates in the pilot
wards
PrU prevalence reduced
from the initial 8.9% to
4% at the end of the 18week period.
No information about
number of subjects, lack
of sample size.
207 long-term care pts.,
stage III or IV PrUs.
3 support surfaces: low-air loss,
upgraded bed overlay, 4hour/day
experimental generic total contact
seat
Number of subjects healed, time to
healing, PrU status score after 4
weeks of treatment; followed 6
months or until healed
Generic total contact seat
superior to low air loss
bed therapy
1168 elderly acute care
patients
1-experimental devices
2-standard devices
Development of nonblanching
erythema
Experimental device
proved better for
preventing blanching
erythema but not
significant for nonblanching erythema
75
Limitations
Healing greatest for airfluidized beds; mean
healing rates greater for
Stage III & IV PrUs on airfluidized beds
Treatment Technical Report
References
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Results
Limitations
Pilot project to
develop a decision
tree for support
surface selection
Sample size not
reported
Skin assessment, PrU risk factor
assessment, Braden scale risk
assessment.
6 support surfaces used.
Reduction in PrU occurrence
50% reduction in PrU
prevalence rate over a 2year period
Lack of sample size, no
statistical analysis, lack
of end-point data.
Care. 2003;16(6):317-27.
Warren JB, Yoder LH, Young
McCaughan S. Development
of a decision tree for support
surfaces: a tool for nursing.
Medsurg Nurs. 1999;8(4):23945.
Indirect Evidence - Pediatric
Reference
Type of Study
Sample
Intervention(s)
Law J. Transair Paediatric
Mattress replacement system
evaluation. Br J Nurs.
2002;11(5):343-6.
Observational study
Four children who were
at high risk of
developing
pressure injury and who
had been nursed in
both the acute and
community sectors
evaluated the Transair®
Pediatric Mattress.
NA
A convenience sample
of 54 healthy children
from the community
ranging in age from
infancy through 18
years was selected.
The total sample size
consisted of 54
children: 24 girls and 30
boys. Their ages ranged
from 3 months to 16
years. Their weight
ranged from 6.43 kg to
98.1 kg, and their
height
ranged from 59.5 cm to
185 cm
NA
McLane KM, Krouskop TA,
McCord S, Fraley JK.
Comparison of interface
pressures in the pediatric
population among various
support surfaces. J Wound
Ostomy Continence Nurs.
. 2002;29(5):242-51.
Descriptive Study
design
Outcome Measures &
Length of Follow-up
They were each nursed on the
Transair® Pediatric Mattress for a
period ranging between 4 and 10
weeks (with an average period of
use being 6.16 weeks).
The children were assessed for skin
damage and comfort.
A comparison was done to
evaluate interface pressures under
the occiput for infants to children
younger than 6 years of age and
under the occiput, coccyx, and heel
for 6- to 18-year-olds.
Five surface combinations were
used for measurements.
The instrument used to measure
the interface pressures was the
Mini-Texas Interface Pressure
Evaluator.
Results
Of the four children who
used this system, no child
experienced
skin damage while being
nursed on theTransair®
Pediatric Mattress.
The responses received in
each case were entirely
positive.
The standard hospital
mattress yielded the
highest interface
pressures.
The Delta Foam overlay
alone or in combination
with the Gel-E-Donut
pillow produced the
lowest occipital pressures
in all age groups.
The Delta foam overlay
produced comparable
pressures to the Efica lowair-loss bed when
measuring the coccyx and
heel interface pressures.
The Delta Foam overlay
76
Limitations
Very small sample size
No control group
Non Randomized
The Efica Hill Rom lowair-loss bed did not have
individual zone
adjustments for children
weighing less than 50 lb.
There was some
variability in the use of
support surfaces in the
infant to < 2 year group.
There was also
variability in the
positioning of the
surfaces that were used.
Non-Randomized study
Treatment Technical Report
Reference
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Results
Limitations
alone or in combination
with the Gel-E-Donut
pillow is a cost effective
and therapeutic choice for
pressure redistribution as
demonstrated in this study
of healthy children.
Solis I, Krouskop T, Trainer N,
Marburger R. Supine
interface pressure in children.
Arch Phys Med Rehabil.
1988;69(7):524-6.
Observational study
13 healthy children
ranging in age from 10
weeks to 13.5 years
were selected for this
study.
The mean age was
7years 3 months.
NA
The study examined interface
pressures generated under
different prominences (occipital,
scapular and sacral)
Relationships between interface
pressure under the occiput,
shoulders and sacrum and
Mechanical characteristics of
surface used to support a child.
A standard mattress, then a 2 inch
and a 4 inch convoluted foam
overlay were the surfaces used in
the study.
77
The highest interface
pressure measurements
obtained in children 6 to
16 years of age were
under the perpendicular
heel. This pressure was
greatly reduced when the
heel was repositioned so
the ankle was on its side in
the oblique position.
The differences in
pressures between the
occiput and scapula,
occiput and sacrum and
scapula and sacrum were
significant (p<0.01), with
the highest pressures
recorded under the
occipital area. Occipital
pressures decreased from
45.7mm Hg on the
standard mattress to
22.3mm Hg on the 4inch
overlay in ages 0 to 2,
54.3mm Hg to 30.5mm Hg
in ages 2 to 10, and
78.0mm Hg to 42.4mm Hg
in ages 10 to 14. Sacral
pressures were highest in
older and larger children,
increasing from 17mm Hg
in ages 0 to 2 to 34mm Hg
in ages 10 to 14, and when
body surface area was
greater than 1m2. These
results indicate that the
site of greatest pressure
Small sample
No control group
No randomization
Treatment Technical Report
Reference
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Results
changes with increasing
age from the occipital area
to the sacral area.
Therefore different
pressure redistribution
considerations are
necessary in treating
pediatric patients than in
managing pressure under
adults.
78
Limitations
Treatment Technical Report
Table 6. Cleansing
Direct Evidence
References
Type of Study
Sample
Intervention(s)
Subjects divided
into 2 groups:
Normal Saline (NS)
group April 2000March 2002,
cleanser (CL) group
April 2001-March
2002. No blinding
or randomization.
189 patients >65 years
old in LTC with stage II
or > PrU: NS group had
84 patients with 95
ulcers. CL group had 90
patients with 90 ulcers.
Compare NS vs. CL in reducing healing
time
Descriptive study of
17 long-term care
(LTC) patients
(patients) with
stage III/IV ulcers
17 ulcers: 7 sacrum, 7
trochanter, 3 ischial
Systematic review
Reference
Type of Study
Clinical update. Solutions,
techniques and pressure in
wound cleansing. Aust Nurs J.
Systematic review
with
recommendations
Konya C, Sanada H, Sugama J,
Okuwa M, Kitagawa A. Does
the use of a cleanser on skin
surrounding pressure ulcers
in older people promote
healing? J Wound Care.
2005;14(4):169-71.
Evidence Level = III
Quality: Fair
Konya C, Sanada H, Sugama J,
Kitayama Y, Ishikawa S,
Togashi H, et al. Skin debris
and micro-organisms on the
peri-wound skin of pressure
ulcers and the influence of
peri-wound cleansing on
microbial flora. Ostomy
Wound Manage.
2005;51(1):50-9.
Outcome Measures &
Length of Follow-up
Measured time to heal using
Kaplan-Meier
Results
Limitations
Irrespective of stage,
healing time shorter with
pH balanced cleanser
especially in stage II
Collect & analyze skin debris found on
peri-wound skin of patients with
pressure ulcers & to evaluate effect of
peri-wound cleansing on micro flora on
peri-wound & wound bed
Skin debris collected: wound bed,
1 cm (peri-wound) and 10 cm
(normal skin) from wound before
cleansing, protein largest quantity
of skin debris (keratinized cells),
counts increased with the amount
of protein
Per wound cleansing
caused a decrease in
wound/peri-wound
microbial counts so
authors suggest periwound cleansing daily
Nurses were not blinded
and cleanser lathered
which may have
facilitated more
aggressive cleansing.
Ulcer location not
mentioned and
lathering may have
been more beneficial
for contaminated sacral
ulcers.
Sample size small; also
location of ulcer (area of
contamination) may
affect microbial load;
elderly population only,
effect on healing was
not studied
3 RCTs were included.
Overall sample sizes
were small with mean
of 60 (range 8 to 123)
To assess effects of cleansing solutions
and techniques on healing rates of
pressure ulcers
Healing rates of pressure ulcers
No studies compared
cleansing with no
cleansing
Need for further
research. Little RCT
evidence available on
wound cleansing for
pressure ulcers.
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Grade A- effectiveness established
to degree that merits application
Grade B-effectiveness established
Results
Limitations
Evidence Level = V
Quality: Good
Also in Table 10 Infection
Moore ZEH, Cowman S.
Wound cleansing for pressure
ulcers. Cochrane Database
Syst Rev. 2005(4):CD004983.
Evidence Level = I
Quality: Strong
Indirect Evidence
79
Chronic wounds may be
cleansed with potable
water (Grade B); boiled &
Treatment Technical Report
Reference
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
to degree that suggests application
Grade C- effectiveness established
to degree that warrants
consideration
Grade D- effectiveness established
to limited degree
Grade E- effectiveness not
established
2006;14(1):20-3.
Quality: Good
Solutions, techniques and
pressure for wound cleansing.
Joanna Briggs Institute Best
Practice. 2006;10(2):1-4.
Systematic review
with
recommendations
14 RCTs: 4 studies with
lacerations; 1 with
traumatic wounds,
open fractures or ulcers
and 7 postoperative
wounds.
Multiple solutions, techniques and
pressures used in wound cleansing
Grade A- effectiveness established
to degree that merits application
Grade B-effectiveness established
to degree that suggests application
Grade C- effectiveness established
to degree that warrants
consideration
Grade D- effectiveness established
to limited degree
Grade E- effectiveness not
established
Beam JW. Wound cleansing:
water or saline? J AthlTrain.
2006;41(2):196-7.
Random/quasi
random
Electronic databases
Rates of infection/healing
24 studies of which 9 met criteria
Randomized/quasi
random
Searched electronic
databases
Assess the effects of water compared
with other solutions
Objective/subjective measures of
wound infection or healing
Quality: Strong
Fernandez R, Griffiths R.
Water for wound cleansing.
Cochrane Database Syst Rev.
80
Results
cooled water is a viable
alternative (grade C).
Irrigation with povidone
iodine is recommended for
contaminated wounds
(Grade B) but no evidence
of the time it should be
left in place (Grade E).
Showering of chronic
wounds undertaken with
caution (Grade C).
Whirlpool may improve
healing rate in PrU (Grade
C). Soaking in povidoneiodine is not effective in
reducing bacterial counts
(Grade B).
Use potable water for
irrigation when saline
unavailable; run tap for 15
sec. Boiled and cooled
water effective in absence
of saline or potable water.
Same recommendations as
above for povidone iodine
in contaminated wounds
(B). Soaking in 1%
povidone iodine not
effective in reducing
bacterial counts (B). 13 psi
irrigation pressure
effective in reducing
infection and
inflammation in
lacerations and traumatic
wounds (B).
No difference in rates of
infection/healing between
tap water/saline in
cleansing of acute/chronic
wounds
5 trials, 3 compared
cleansing with no
cleansing, 1 compared
Limitations
Multiple types of
wounds. Recommend
reading full report at:
http://www.joannabriggs
.edu.au/pdf/BPISEng_10_
2.pdf
Method quality of
studies, more studies
needed
No standard criteria for
measuring infection
which limited ability to
Treatment Technical Report
Reference
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
2008(1).
Quality: Strong
Results
Limitations
cleansing with procaine
spirit, risk of developing
infection when cleansed
with tap water compared
with saline was 0.16, no
diff in infection rates when
wounds cleansed with tap
water vs. not cleansed at
all
14 randomized trials-no
difference in
infection/healing rates in
acute/chronic wounds
with either tap water or
saline, irrigation pressure
of 13 psi for both children
& adults, 1 study with low
power to support use of
potable water, povidoneiodine for contaminated
wounds
7 of 10 patients reduced
wound size after 3 weeks
pool data
Fernandez R, Griffiths R, Ussia
C. Effectiveness of solutions,
techniques and pressure in
wound cleansing. JBI Reports.
2004;2(7):231-70.
Systematic review
of randomized &
clinical controlled
trials
Electronic databases
Assess effectiveness of different
solutions, pressures, & techniques
Horrocks A. Prontosan wound
irrigation and gel:
management of chronic
wounds. Br J Nurs.
2006;15(22):1222.
Before and after
study
10 patients with chronic
wounds
Evaluate 10 patients in community
with chronic wounds, previous.
treatment with NACL > 1month
Wound size, patient comfort, ease
of application, compare use of
antibiotic/silver prior to & during
use of Prontosan®
In-vivo study
involving goats
12 adult male goats
Compared efficacy of pulsed lavage
and bulb syringe in reducing bacterial
counts in contaminated wound from
animal model
Used bioluminescent bacteria to
allow for changes in quantity &
distribution of bacteria to be
visualized with multiple volumes of
irrigant
Pulsed lavage more
effective than bulb syringe
in reducing bacteria
luminescence after 6 & 9 L
of irrigation
Animal musculoskeletal
model, used acute
wounds, bacteria may not
be representative of what
is found in chronic
pressure wounds
Prospective
randomized trial
over 14 months
Patients aged 1-17
years with simple
laceration seen in urban
pediatric emergency
department. 530
Compare infection rates of wounds
irrigated with saline vs. running tap
water.
Saline-100 ml with 30-60 syringe & 18
gauge angiocath vs. running tap water
Patients seen initially then within
48-72 hours for signs of wound
infection.
14 wounds infected-- 7 in
saline group and 7 in
water group
Lacerations and not
chronic wound like
pressure ulcers, selection
bias using odd and even
days for patient selection
Quality: Fair
Svoboda SJ, Bice TG, Gooden
HA, Brooks DE, Thomas DB,
Wenke JC. Comparison of
bulb syringe and pulsed
lavage irrigation with use of a
bioluminescent
musculoskeletal wound
model. J Bone Joint Surg Am.
2006;88A(10):2167-74.
Quality: Good
Valente JH, Forti RJ,
Freundlich LF, Zandieh SO,
Crain EF. Wound irrigation in
children: saline solution or
tap water? Ann Emerg Med.
81
Wounds “appeared” to
contain biofilm, sample
small, 1 PrU
Treatment Technical Report
Reference
Type of Study
2003;41(5):609-16.
Quality: Strong
Wilson JR, Mills JG, Prather
ID, Dimitrijevich SD. A toxicity
index of skin and wound
cleansers used on in vitro
fibroblasts and keratinocytes.
Adv Skin Wound Care.
2005;18(7):373-8.
In vitro cellular
model with
fibroblasts &
keratinocytes
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
patients enrolled
for 10 sec (approximately 1.5 L).
17 cleansers and 3
liquid bath soaps
Evaluated cleansers effect on human
infant dermal fibroblasts and
epidermal keratinocytes exposing
them to 10 serial dilutions
Quality: Good
82
Skin cleansers were most toxic to
fibroblasts with indexes between
10,000 to 100,000
Results
In-vitro monolayers of
normal human skin cells
(fibroblasts, keratinocytes)
are reliable models for
screening for toxicity of
cleansers
Limitations
to group, water not
tested for particulate
matter
In vitro, so difficult to
translate into pressure
ulcer wounds
Treatment Technical Report
Table 7. Debridement
Direct Evidence
References
Alvarez OM, FernandezObregon A, Rogers RS,
Bergamo L, Masso J, Black M.
A prospective, randomized,
comparative study of
collagenase and papain-urea
for pressure ulcer
debridement. Wounds.
2002;14(8):293-301.
Evidence Level = II
Type of Study
Sample
Intervention(s)
Prospective,
randomized,
parallel, group, tricenter, open-label,
clinical trial
N=28 subjects (nursing
home patients);26
completed study (2
dropped out early 2
unrelated treatment
issues)
Inclusion:

 18 years of age

Stage II, III & IV
PrUs

Nonviable tissue
attached to ulcer
base

If ulcer located on
feet, must have
ABI  0.75 or
normal PVR to r/o
arterial disease
Exclusion:

Clinical signs of
infection

Cellulitis

Osteomyelitis

Inadequate
nutrition

Uncontrolled DM

Renal, hepatic,
hematological,
neurologic, or
immunological dz.
Patients on
corticosteroids,
immunosuppressive
agents, radiation or
chemo within 1 month
prior to study entry
1-2 week screening period to stabilize
wound & institution of physical &
supportive treatment:
-Cleanse with sterile NS
-Dress with nonadherent 1 dressing
-NS moist to moist dressing
- dressing daily & prn
* After screening period, if target ulcer
& area of necrosis stable ( 20%  in
size) or improving ( in size), patient
advanced to
randomization
Papain/Urea (n=14)
Collagenase: (n= 12 evaluable)
Treatment protocol:
-If thick hard eschar is present, crosshatch with # 10 blade
-Cleanse with NS
-No forceful irrigation
-Apply study medication over entire
surface of nonviable tissue (1 x daily
using a tongue depressor (approximate
thickness of a nickel, 2 mm) (* If the
dressing dislodged or soiled, only 1
additional application of test agent
allowed)
-Apply lightly fluffed NS moistened
gauze
-Cover with dry gauze
-All subjects were placed on pressure
redistribution sleep surfaces & chair
cushions (selection was determined by
the investigational team & dependent
upon ulcer location & consistent with
the AHCPR Guidelines)
-Subjects confined to bed were
83
Outcome Measures &
Length of Follow-up
-Ability to effectively debride
devitalized tissue in PrUs
-Tracing & wound assessment
education performed for all study
personnel prior to study initiation
(interrater reliability was 91% for
clinical evaluations & 94% for
tracings)
-Subjects were evaluated prior to
screening & weekly during
screening for a min of 1 week
-Speed of debridement was
evaluated 1 x/week for the 1st
week, then 2x/weekly for 3 weeks
-Non-viable tissue was described
as:

Adherent yellow/gray/white
slough

Adherent soft black eschar

Firmly adherent black eschar

Line of demarcation between
nonviable & viable was
measured

% of wound coverage with
nonviable tissue was
objectively measured using
tracings

Wound surface area &
attached tissue were
determined by computerized
planimetry of surface
tracings made with acetate
transparent film
-Wound evaluation included:

Overall wound condition

Edges (undermining)

Odor

Wound pain

Exudate

Peripheral tissue
Results
Limitations
-1 Efficacy endpoint was
resolution of nonviable
tissue
-Other endpoint was
presence of granulation
tissue
-Small sample size,
therefore strong
scientific conclusions
cannot be made
-Author’s initial intent
was to perform a
double-blind study, but
the physical differences
in ointments precluded
such
- ? 4 Stage II PrUs were
included
-No demographical
differences between
groups
-No significant difference
(p 0.05) between groups
with respect to ulcer size
& amount of nonviable
tissue @ baseline
-Ointment application was
considered easy &
convenient
-Papain-urea ointment
was significantly more
effective (p0.0167) in
debriding at all 3 time
points
-Reduction in area of
nonviable tissue covering
wounds over time was
significantly greater
(p0.0167) for papain-urea
at all 3 evaluations
-Visual scores showed that
granulation was
significantly (p0.0167)
greater for papain-urea
- Neither were associated
with pain or discomfort
Treatment Technical Report
References
Type of Study
Sample
Intervention(s)
repositioned: q 2 hours using pillows &
foam wedges whenever possible
-Written turning schedules & diaries
were kept on all subjects
-1 investigator or CSC at each site
performed all evaluations
-If infected, infection had to be
resolved prior to enrollment
Bale S, Banks V, Haglestein S,
Harding KG. A comparison of
two amorphous hydrogels in
the debridement of pressure
sores. J Wound Care.
1998;7(2):65-8.
Randomized,
controlled, blinded
trial
Evidence Level = II
Burgos A, Gimenez, J,
Moreno, E, Lanberto, E, et al.
Cost, efficacy, efficiency and
tolerability of collagenase
Multi-center,
randomized, nonblind, parallel study
conducted at seven
N=50 subjects (hospital
& community); 38
completed study
Inclusion:
 Stage II-IV
(NPUAP Staging,
1989) “with
necrosis”
Exclusion:
 Ulcers >8 cm
diameter
 Immunosuppres
sion
 Pregnant or
nursing
 Within another
clinical trial
within <1 month
prior
If already participated
in this trial
Group A (Sterigel) (n=21)
 ∆ Daily
 Cover with Telfa & Tegaderm
Thirty-seven patients
were randomized using
a computer-generated
randomized list into
Topical enzyme vs.
Hydrocolloid
Group B (Intrasite) (n= 69)

∆ Daily

Cover with Telfa & Tegaderm
Duration, max 4 weeks or until wound
debrided, whichever sooner
Outcome Measures &
Length of Follow-up

Induration

Edema

Erythema

Amount granulation

Amount re-epithelialization
(using surface area wound
tracings)
84
Limitations
No statistical significance
between groups, in:

Time to debride

Pain experienced

Pain upon dressing
removal

Odor
Development of
maceration
-Stage II ulcers included
-Small sample size
(???Staging accuracy)
-Evaluation tool not fully
described
-??Granulation classified
as necrosis
-Large # of subject
withdrawals 2 to
general ill health –
-? Standardization of
photos & tracings
37 evaluable patients were
included in the study;
77.8% had albumin levels
of ≤ 3.5 g/dl

Wounds were treatment. Until
complete debridement or 4 weeks.
-Full assessment by nurse caring
for subject q 7 days until end of
study day 28
-Necrosis classified by 1 of 4
categories:
1. Black
2. Green
3. Yellow
4. Red
-Photos & tracings taken @ each
assessment
-Effect of dressing on surrounding
skin measured by study nurse (5
options; dry/flaky to macerated)
-Wound odor measured by
selecting; none, intermittent,
continuous
-Pain measured by selecting: none,
intermittent, continuous
-Pain on removal of dressing; pain,
slight pain & severe pain
-Photos submitted for
computerized wound analysis,
undertaken by an independent
assessor who was blind to
treatment groups to confirm or
reject subjective nursing
assessments
Ulcer assessments were
performed by direct & indirect
methods:
Topical enzyme Collagenase (Iruxol):
Results

No discussion on
debridement
outcomes
No discussion on
Treatment Technical Report
References
ointment versus hydrocolloid
occlusive dressing in the
treatment of pressure ulcers:
a comparative, randomized,
multicentre study. Clin Drug
Invest. 2000;19(5):357-365.
Evidence Level = II
Type of Study
Sample
Intervention(s)
hospitals in Spain
blocks of 4 patients to
receive either:
1. Collagenase
ointment
(Iruxol)
2. Hydrocolloid
(Varhesive)
Inclusion:

Patients aged 55
years or older

Stage III PrUs (to a
depth of
subcutaneous
tissue) for less
than one year
duration
(n=18)
-Applied once daily in a 1 to 2 mm thick
layer to the wound bed
Exclusion:

End-stage organ
disease

Localized or
systemic s/s of
infection (fever,
local erythema,
regional lymph
node swelling)
Hypersensitivity to
collagenase
At baseline, all subjects received:
-History & physicals
-Arnell scoring (not defined)
-Blood testing (hematological &
biochemical parameters, including
serum albumin)
-Exudate samples were taken for
microbiological studies
Hydrocolloid (Varihesive): (n-19)
-Ulcers were cleansed with sterile NS
-HCD applied and ∆ed q 3rd day, sooner
if leaking
-To ulcers that were deep or with large
amounts of drainage, Varihesive paste
was applied and the ulcer was covered
with a HCD
Treatment was continued for 12 weeks
or until complete ulcer healing,
whichever occurred first
Outcome Measures &
Length of Follow-up
Direct Measurements:
-Ulcer perimeter outline was
traced onto a labeled transparent
acetate film
The surface area was calculated
using planimetry by an observer
blind to therapeutic assignment
Results
Indirect Measurement:
-An identification label was placed
at each ulcer margin and ulcers
were photographed according to a
standardized method at 50 cm
from the focus and the contour of
each ulcer was transferred to a
transparent acetate
Reasons for
discontinuation included,
death due to unrelated
cause (n=4), hospital
discharge (n=4) and
transfer to another
hospital (n=3), protocol
violation (n=2),
deterioration of general
patient condition (n=1)
(and for the HCD arm lack
of efficacy (n=1)
All wound examinations were
performed weekly & consisted of:
-Ulcer photography
-Assessment of ulcer are (1
outcome measure)
-Adverse reactions to study
treatment
-Evaluation of 4 ulcer
characteristics (pain, % granulation
tissue, exudates and odor all
measured on a 5 point scale)
Cost associated with each study
treatment was determined by the
cost of the study products,
ancillary supplies and labor costs
of nursing staff
85
-Eight (44.4%) and six
(31.6%) patients in the
collagenase and HCD
groups respectively,
discontinued the study
prematurely,
There was a stat significant
difference in those who
discontinued early and
those who completed the
12 week course, with the
former group exhibiting a
mean ulcer area increase
and the later a decrease
(p=0.023) Of those in the
collagenase group who left
the study prematurely
there was a statistically
significant decrease in
mean ulcer area from the
HCD group who left early
(p=0.021)
Given that subjects who
discontinued treatment
early introduced bias, an
intent-to-treat analysis
was performed
Differences in the direct
and indirect ulcer
measurement methods
Limitations
standardization of
care as it pertains
to pressure
redistribution and
nutritional
interventions

Small sample size

No blinding
Arnell scoring not
defined
Treatment Technical Report
References
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Results
were not statistically
significant
-After 12 weeks 83.3% of
subjects receiving
collagenase exhibited a
reduction in ulcer area, vs.
73.7% of those treated
with HCD, the difference
did not reach stat
significance
-Complete healing was
achieved in six (16.2%) of
patients, 3 in each
treatment arm
-Efficacy analyses reported
an ulcer reduction of
44.2% in the collagenase
group and 27.9% in the
HCD group
-Cost analyses between
the two group was stat
significant (p0.0001)
-Efficacy analyses showed
no stat significant
differences between the
groups
-Pain intensity was stat
significantly decreased in
those receiving
collagenase (p=0.001)
-Granulation tissue ↑
(p0.0005) & exudates ↓
(p 0.0005) in both
treatment groups
-1 subject in the
collagenase group
developed dermatitis and
1 in the HCD presented
with ↑ erythema and
exudates
-Treatment efficacy cost
tended to be lower in the
collagenase group than in
the HCD
-Tolerability of both
86
Limitations
Treatment Technical Report
References
Burke DT, Ho CH, Saucier MA,
Stewart G. Effects of
hydrotherapy on pressure
ulcer healing. Am J Phys Med
Rehabil. 1998;77(5):394-8.
Type of Study
Randomized
controlled trial
Evidence Level = II
Colin D, Kurring P, Quinlan D,
Yvon C. Managing sloughy
pressure sores. J Wound Care.
1996;5(10):444-6.
Evidence Level = II
Open, multicenter,
multinational,
parallel group,
prospective
randomized, study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
N=18 subjects with 42
PrUs
Inclusion:

Hospitalized inpatients

Stage II or IV
Exclusion:

Cardiac
arrhythmias

Use of lifemonitoring
equipment
Group 1 (Control) Non-whirlpool(n=18)

Mechanical debridement

FlexiCair Bed (sacral, ischial or
trochanteric PrU)
Group 2 (Treatment) Whirlpool: (n=
24)

Same as Group 1

20 minutes min of whirlpool
therapy 1x daily (96-98 F)
Instrument(s): not stated
Items: wound size (T-test to
compare mean ∆ in wound size
across groups)
N=135 (120 patients
completed the study); 6
trial centers
Patients were randomly allocated to
one of two treatment groups:
1 outcome measure:
- % reduction in the area of nonviable tissue during the 21 day
period (measured by Wilcoxon
Rank Sum Test)
Hydrogel (Intrasite Gel) & secondary
dressing Melain (n=67)
Inclusion:
 PrUs containing
slough
 Pressure ulcers
Grades I-IV
Exclusion:
 Not stated
When a patient
presented with more
than one PrU, only the
largest ulcer was
assessed as part of this
study; other ulcers were
treatments was good
Study was not able to
detect stat significant
differences between the
two treatments, but the
collagenase exhibited a
trend toward greater
efficacy and efficiency
Group 1 (Non-whirlpool):

Improved-n=5 (28%
of patients)

No ∆- n=2 (11% of
patients)

Deterioration- n= 11
(61% of patients)
Group 2 (Whirlpool):

Improved-n=14 (58%
of patients)

No ∆- n=1 (4% of
patients)

Deterioration- n= 9
(38% of patients)
Dextranomer (Debrisan Paste) paste &
secondary dressing Melain (n= 68)
2 outcome measure:
-Median % reduction in wound
surface area
-Wound assessments and an
evaluation of dressing characteristics
were performed q 7 days
-Wound photographs were taken at
the initial and final assessments
-Data on patient comfort was assessed
subjectively, as was ease of application
(Likert scale)
-Data on ease of application was
collected
-Study duration continued until
the wound was fully debrided or
on completion of 21 days of
treatment, whichever was earlier
87
Results
Outcome analyses were
performed on the
intention-to- treat
population (this includes
all patients completing at
least on follow-up visit
(135 patients enrolled, 120
completed the study)
At day 21, the median %
reduction in non-viable
tissue was 74% in the
amorphous hydrogel
group compared with 62%
in the dextranomer paste
group, which was not
statistically significant
(p=0.20).
-At day 21 the median
reduction in PrU area was
Limitations
-Wound bacterial count
& effect of bacterial
load on reduction of
wound size were not
measured
Subjects should have
been randomized, not
the ulcers; possible
confounding bias
-Inclusion and exclusion
criteria not well defined
-Question
appropriateness of
including Grade I and II
PrUs included
-Dressing change
procedures, frequency
not described
-Uncertain if
standardization of
overall PrU
management was
implemented, not
described
-Practice setting of
treatment not described
-No blinding
- Short follow-up
timeframe
Treatment Technical Report
References
Type of Study
Sample
treated with the same
randomized dressing if
considered clinically
appropriate by the
investigator
Intervention(s)
Outcome Measures &
Length of Follow-up
Results
Limitations
statistically significant
(p=0.03); 35% reduction in
hydrogel treated PrU
compared to 7%in the
dextranomer treated
group
- 8 (12%) of Hydrogel
treated ulcers
deteriorated and 13 (19%)
of dextranomer treated
ulcer deteriorated
-The only reported
dressing related adverse
event was in the
dextranomer treated
group and that was pain
with dressing application
-Assessments at days 7,14
& 21 found the amorphous
hydrogel to be easier to
apply and remove than the
dextranomer paste and
was associated with less
pain
-Both dressing types were applied and
changed according to manufacturer’s
instructions. The secondary dressing
used for both treatment groups was a
non-occlusive absorbent dressing
(Melolin)
Patient outcomes:
Hydrogel (n=67)
-53 (79%) completed
study; 14 (21%) were
withdrawn; 1 Adverse
incident, 2 died and 11 lost
to follow-up
Dextranomer paste (n=68)
-43 (63%) ) completed
study; 25 (37%) were
withdrawn; 4 Adverse
events, 2 died and 19 were
lost to follow-up
Martin SJ, Corrado OJ, Kay EA.
Enzymatic debridement for
necrotic wounds. J Wound
Randomized,
double-blind,
controlled trial
N=17 subjects (21 PrUs)
Inclusion:

Grade IV PrU
Group A; (n=11)

Enzyme in KY Jelly

Administered 1x daily
88
-Independently assessed & photo
daily
-Data form used (not described)
Group A:
-Mean (11.8 days); SD 2.9
Enzyme in KY Jelly Group
-Small sample size
-Not powered
-Grade IV stated, but
Treatment Technical Report
References
Type of Study
Care. 1996;5(7):310-1.
Evidence Level = II
Matzen S, Peschardt A,
Alsbjorn B. A new amorphous
hydrocolloid for the
treatment of pressure sores:
a randomised controlled
study. Scand J Plast Reconstr
Surg Hand Surg.
1999;33(1):13-5.
Evidence Level= II
Also in Table 9 Dressings
Randomized,
controlled study
Sample
Intervention(s)

If > 1 ulcer, each
entered
separately
Exclusion:

Treatment with
Streptokinase
/streptodornase
(Enzyme) within 4
weeks

Terminally ill

Unable to consent

Covered by thin film dressing
Group B: (n= 10)

Hydrogel (KY Jelly)

1 x daily

Thin film
N=32 patients enrolled
(12 patients completed
the study; 9 patients in
the hydrogel arm & 11
in the control arm
withdrew) (Outpatient
clinic in Copenhagen)
Patients were randomly allocated to
one of two treatment groups after an
initial sharp debridement in the
outpatient clinic.
Inclusion:
 Stage III & IV
PrUs
 Non-infected
 Sacral &
trochanteric
Exclusion:
 Location other
than sacral or
trochanteric
 Patients with
diseases or
taking drugs
known to impair
healing
Outcome Measures &
Length of Follow-up
-Mean, range & SD for eschar
removal calculated for Groups
A&B
-Endpoint was eschar removal
Results
Limitations
Group B:
-Mean (8.1 days); SD 1.8,
KY Jelly alone
described as ulcers with
eschar
-Only stats are (mean,
SD, range)
-Data collection tool not
described
No statistical significance
between groups
Double-blind (Treatment agent in
syringes)
(Control) Saline moistened gauze
(n=15):
-Ulcer cleansed daily (agent not
specified)
-Dressing ∆ daily
-Covered with Comfeel Transparent
Dressing (Coloplast)
(Treatment) Amorphous hydrocolloid
(Coloplast A/S, Denmark) (n= 17):
-Ulcer cleansed daily (agent not
specified)
-Dressing ∆ daily
-Covered with Comfeel Transparent
Dressing (Coloplast)
-Once weekly the healing of the ulcers
was estimated by the same
investigator measuring the amount of
water needed to fill the cavity
-The need for debridement was
evaluated and was performed as
needed
89
1 outcome measure was to
compare the effect of a new
amorphous hydrocolloid with that
of conventional treatment on PrU
healing time
2 outcome measure was to
compare the frequency of
required PrU debridements in the
two treatment groups
Patients were followed for 12
weeks or until the ulcer healed in
their home environment
-Relative volumes (from
the initial 100%) of
hydrogel treated wounds
were significantly less (26
± 20%, p< 0.02) than those
of saline treated wounds
(64 16%) in the last week
of the study
-The saline treated
wounds required more
frequent weekly
debridements than the
hydrogel treated wounds
(21% compared with 7% of
all weekly dressings, p
0.03)
- During the period of the
study 5 of the hydrogeltreated ulcers healed,
whereas none in the
control arm healed
-6 of the patients in the
saline gauze group
developed necrotic tissue
with infection and
therefore required surgical
revision after which they
were no longer included in
the study
-In general all dressing had
to be ∆ed ever day with no
significant differences in
leakage of exudates from
-In the exclusion patient
medical history
exclusionary variables
not described
-No blinding
-Small sample size
-High withdrawal rate,
further limiting sample
size and generalizability
of findings
-No discussion of
standardization of any
other components of
treatment
-Estimated
measurement of volume
by filling with water
-No discussion of
randomization method
Treatment Technical Report
References
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Results
Limitations
the wounds
- No statistically significant
difference between the
two treatment arms
related to odor, pain
during treatment, comfort
during use, nor length of
time dressings required
(days)
-(20 patients in total
withdrew); 9 patients in
the hydrogel group
withdrew (because of
other illness (n=5); death
(n=2); missing
appointment (n=1) and a
wish to discontinue
participation (n=1)); 11
patients in the control arm
withdrew; because of
insufficient effect of
treatment (n=6); other
illness (n=3); death (n=1);
wish to discontinue
participation (n=1)
-Results of intent to treat
population was analyzed
Muller E, van Leen MW,
Bergemann R. Economic
evaluation of collagenasecontaining ointment and
hydrocolloid dressing in the
treatment of pressure ulcers.
Pharmacoeconomics.
2001;19(12):1209-16.
Prospective,
Randomized, trial
N=23 eligible female
subjects (orthopedic hip
surgery patients in a
Netherlands hospital);
Subject age range 65-79
years
Inclusion:
 Stage IV PrU on
-After autolysis led to release of
necrotic tissue, then surgical
debridement was performed to
achieve a clean wound bed
-Following debridement, subjects were
randomized to either the collagenase
or HCD group
90
1 outcome parameter:
-Complete healing
2 outcome parameter:
-Weeks required to achieve
healing
-Data was skewed and
therefore were assessed
by the non-parametric
Mann-Whitney test.
Differences were accepted
as significant if the
probability was less than
0.05
-11 of 12 (91.7%) of
subjects achieved
complete epithelialization
with collagenase; versus 7
of 11 (63.6%) in the
hydrocolloid group
(p0.005)
-Time to achieve healing
-All subjects female
-Small sample size
-Subjects were all
surgically debrided prior
to enrollment, outcome
measures examined
healing times not
debridement
Treatment Technical Report
References
Type of Study
Evidence Level = II
(Examined healing and cost,
not debridement)
Sample
Intervention(s)
the heel
Exclusion:
 Life expectancy
 6 months
Collagenase-containing ointment
(Novuxol) (n=12)
 Cleanse with NS
 Once daily ointment
application
 Cover with paraffin gauze
(Jelonet)
 Absorbent gauze
Outcome Measures &
Length of Follow-up
Treatment efficacy was
determined by size & depth of the
ulcer, signs of inflammation,
formation of granulation and
epithelialization
-MD performed clinical
assessments weekly including
photography
Results
Limitations
was 6-12 weeks (mean 10
weeks) in the collagenase
arm & 11-16 weeks (mean
14 weeks)in the HCD arm
(p0.005)
-HCD reported to be 51%
more costly than
collagenase per
successfully treated
patient
-Number of treatment
failures not discussed
-1 week before & 1 week before
the last week of the study, the
following lab tests were
performed: blood serum albumin,
serum creatinine, serum
transferrin, Hgb, TP, TLC and WBC.
-All research data & comments
were captured on NCR CRFs.
-Healing was the 1 endpoint &
was based on re-epithelialization
as determined by area
measurement & clinical
assessment. -Wound length,
width, depth, volume, area, &
perimeter were determined using
Computerized Imaging System
(CIS) (DynaMedics Corporation,
Keller, Tex).
-7 subjects (Stage II=3;
Stage III=4) completed the
study. All Stage II & 2 of
the Stage III ulcers healed;
4 Stage II were categorized
as healing (≥ 60%
improvement) after 12
weeks of care.
-No dressing related
adverse events occurred
-Subject product
acceptance, including
comfort was high.
-The dressing cost is
reasonable & the only 2
dressing used was gauze.
-Very small sample size
(n=7), not generalizable
-No comparative group
-Question inappropriate
inclusion of Stage II
ulcers
-Additional studies
could be performed
with film or foam to
determine if  wear
time could be achieved;
thereby  dressing &
labor costs.
-Additional studies
designed to define the
possible contribution of
endopeptidase enzymes
in wound healing are
Hydrocolloid (Duoderm) (n= 12)

∆ twice per week
Treatment & clinical evaluation
continued until total epithelialization
was achieved
-Formation of necrotic tissue was
considered treatment failure &
resulted in the patient receiving a
different treatment regime. The ulcer
would be debrided again and treated
with an alginate dressing (Kaltostat) or
a combination of Kaltostat &
collagenase
Parnell LKS, Ciufi B, Gokoo CF.
Preliminary use of a hydrogel
containing enzymes in the
treatment of stage II and
stage III pressure ulcers.
Ostomy Wound Manage.
2005;51(8):50-60.
Evidence Level = III
Prospective study
10 nursing home
residents with Stage II
(n=3) and Stage III (n=7)
PrUs that had failed to
heal during a 3-month
period.
-Ulcers were cleansed daily with NS
using aseptic technique. -Following
cleansing, the wound bed was blotted
dry with gauze, a thin layer of hydrogel
(approximately ¼ inch thick) was
applied &
covered with a 2 gauze dressing
-Wounds were dressed 1 x/day unless
soiled or displaced.
-All other regimens (e.g., turning,
bathing, and similar activities) were
performed per each facility’s policies
and procedures (unchanged from the
previous 3 months).
91
Treatment Technical Report
References
Pullen R, Popp R, Volkers P,
Füsgen I. Prospective
randomized double-blind
study of the wound-debriding
effects of collagenase and
fibrinolysin/deoxyribonucleas
e in pressure ulcers. Age
Ageing. 2002;31(2):126-30.
Evidence Level = II
Type of Study
Prospective,
randomized,
double-blind
Sample
N=135 subjects
Inclusion:

Seiler Stage 2,3 or
4 with fibrinous
&/or necrotic
slough

If several PrUs,
worst one chosen

Between 2-14.5
cm diameter (to
allow photo
assessment)
Exclusion:

Drug or ETOH
dependence

h/o
hypersensitivity to
collagenase or
F/DNAse

Planned co-
Intervention(s)
Outcome Measures &
Length of Follow-up
Collagenase (n=66)

2x/day

Covered with gauze

Continued until complete
debridement or max of 4 weeks
F/DNAse: (n= 69)

2x/day

Covered with gauze

Continued until complete
debridement or max of 4 weeks
92
-12 Baseline photos taken
-Photo q 4days (standardized
distance & flash)
-Scale with color range placed by
each lesion
1º Efficacy:
-Δ in area of necrosis from
baseline to end (or premature
withdrawal)
-Assessed by 2 independent
blinded dermatologists by 13x18
cm photos, classified into 5
categories:
1. Clear ↑ (≥ 100%)
2. ↑ (≥ 30%)
3. No ∆
4. ↓ (≥ 25%)
5. Clear ↓ (≥ 50%)
Efficacy objective: (subjective by 2
independent MDs)
Results
-Of the “per-protocol
population” (n=78), no stat
sign difference between
arms (p=0.164)
-From the 121 patients
“(intention to treatment
pop”) ↓ in necrotic tissue
reported for 37 (61.7%) for
collagenase, compared
with 35 (57.4%) of those
with F/DNAse no stat sign
difference
No statistical significance
between groups
Limitations
warranted.
-Pre-established scales
developed specifically
for this evaluation were
used in this instrument,
but formal reliability &
validity testing was not
performed.
-Retrospective review of
the medical chart for
the 3 month historical
control presents
limitations.
-Although wound
measurements,
treatment regimes, &
nursing notes provided
useful information for
control data
inexpensively, the
historical perspective
lacks direct comparison
of placebo & test
articles between
subjects
-Physicians selected
support surface &
turning intervals ( no
standardization)
-Reliability of measures
-Potential bias
Treatment Technical Report
References
Type of Study
Sample

Intervention(s)
Outcome Measures &
Length of Follow-up
1. Environment of wound
2. Wound margins
3. Wound depth
4. Pocketing
5. Area
Wound healing
Results
Limitations
Maggot treatment
Conventional Treatment
Photo planography of:
1. Dimensions: l, w,
circumference & surface area
2. Outcomes
-Relative & absolute ∆ in surface
area
-% necrotic tissue vs. granulation
tissue
-Complete debridement
-Complete closure
--Calculated by : ∆ sA (t2-1)
Mean circumference  (t2-1)

T1= initial observation
T2=final observation

% Necrotic wounds
debrided (MDT 80%;
vs. Conventional
48%)

Weeks to 50%
debridement (MDT
1.4 vs. Conventional
4)

Weeks to 100%
debridement (MDT 8
vs. 17)

∆ in SA/week (MDT 1.6 vs. Conventional
+0.3)

∆ in % granulation
13% vs. 3.3%)

Average time to
complete healing
(MDT 12 weeks vs.
13.4 weeks)
% Healed (MDT 39% vs.
21%)

Outcome Measures &
Length of Follow-up
-Evaluation of efficacy, safety and
economic impact of using the
Results
Limitations
A multiple regression
model was fitted with
-Retrospective study
with historical
medication with
(antiseptics,
antibiotics,
occlusive dressing,
hydrogels or
HCDs)
Location not
permitting parallel
positioning of
reference scale
Subject age range (5594 years)
Sherman RA. Maggot versus
conservative debridement
therapy for the treatment of
pressure ulcers. Wound
Repair Regen.
2002;10(4):208-14.
Clinical series,
retrospective
analysis
Evidence Level = III
Convenience sample
(N=67 subjects; with 92
PrUs); initially cohort of
103 subjects
Inclusion:

Wounds with
complex nonplanar topography

Wounds
photographed
without scale
markers

f/u  2 weeks
Exclusion:

Underlying
osteomyelitis
Rapidly advancing
infection
Weak
methodology

Extremely limited
access to
treatment

Wound size larger
in MDT arm
(p=0.035)

MDT patient
characteristics (SCI
(p0.05)

DM (P0.05)
(favored
Conventional
treatment)
No description of
Conventional
treatment.
Indirect Evidence
Reference
Type of Study
Sample
Intervention(s)
Granick MS, Posnett J, Jacoby
M, Noruthun S, Ganchi PA,
Retrospective with
historical control
N=62 patients (from a
Plastic Surgery practice
-Retrospective chart review of those
patients having undergone:
93
Treatment Technical Report
Reference
Datiashvili RO. Efficacy and
cost-effectiveness of a highpowered parallel waterjet for
wound debridement. Wound
Repair Regen.
2006;14(4):394-7.
Type of Study
Sample
Intervention(s)
the records of all 40
patients having
undergone excisional
debridement (ICD 9-CM
code 86.22) in 2003 with
Versajet were compared
with a control group
treated with
conventional
debridement in 2002)
Versajet Study Group (n=40))compared
to Conventional sharp debridement
Control Group (n= 22)
Inclusion:
 Patients whose
wounds were
treated with
Versajet by the
Plastic Surgery
Department in
2003
 Patients whose
wounds were
treated with
conventional
sharp
debridement
(scalpel, curette
and electro
cautery) by the
senior surgeon in
2002
 Acute and
chronic wounds
Outcome Measures &
Length of Follow-up
Versajet compared to conventional
sharp debridement. Patient’s
Medical Records which were coded
as excisional debridement where
Versajet was utilized in 2003 was
compared with patients similarly
coded as having undergone
conventional sharp debridement in
2002
Results
Limitations
covariates for patient age,
wound area and treatment
group to determine
whether there was a
difference in debridement
time. A logistic regression
model was fitted to the
number of procedures
with covariates for patient
age, wound area, and
treatment group to assess
the difference between
groups in the odds of
having a lower number of
procedures relative to a
higher number of
procedures
unmatched controls
-Versajet 51% acute
wounds & 49% chronic;
Conventional treatment
36% acute & 64%
chronic
-Median wound area
was 88 cm2 in Versajet
Group compared to 213
cm2 in the Conventional
Group (p=0.016)
-The patient samplings
were well matched in
terms of gender, age,
admitting diagnosis and
wound type.. But the
median wound area was
significantly larger in the
control group (p=0.016)
-The mean number of
surgical procedures was
significantly less with
Versajet (p=0.0002).
-The odds of having a
lower number of
procedures were
significantly greater with
Versajet than with
conventional debridement
(p=0.010)
-Wounds treated with
Versajet were Acute
(51%), chronic (49%), PrUs
(30%)
-The conventional sharp
debridement population
consisted of acute (36%),
Exclusion:
Wounds treated with
debridement methods
other than scalpel,
curette, electro cautery
or Versajet
94
Treatment Technical Report
Reference
Mosti G, Mattaliano, V.l. The
debridement of chronic leg
ulcers by means of a new,
fluidjet-based device.
Wounds. 2006;18(8):227-337.
Type of Study
(Not specified by
authors)
Non-randomized
trial with
convenience
sampling
Sample
N= 469 hospitalized
patients with chronic
vascular leg ulcers in
Italy; 142 treated with
Versajet Hydrosurgery
System & 327 treated
with moist dressings
(Control)
Inclusion:
 Chronic vascular
leg ulcer (e.g.
Arterial, venous,
mixed etiology,
vasculitis, posttraumatic,
iatrogenic,
microangiopathy)
 > 70% of ulcer
surface covered
by necrotic tissue
or thick fibrin
slough with or
without exudates
 Presence of
hypertrophic
granulation tissue
Exposed tendon or bone
Intervention(s)
Outcome Measures &
Length of Follow-up
Treatment Group: (n=142)
 Hydrosurgical debridement
 Performed daily or every other
day
 Moist dressings also used (type
not specific)
Control Group: (n= 327)
 Moist dressings (hydrogel and HCD
dressings)
Outcomes Measured:
-Time to complete debridement
-Effect on bacterial burden
-Procedure-related pain with Visual
Analogue Scale
-Bleeding complications
Patients were followed until
wound closure
The effects of the 2 debriding
methods were followed in 3
patients who had large bilateral
ulcers (1 ulcer treated with
Hydrosurgical device & the other
the control). Before treatment &
after 24 & 48 hours of treatment
2ml of exudates were collected
and the levels of IL-I, IL-6, TNF-,
ICAM-1, VCAM-1, MMP-9, IL-10
were measured
Results
chronic (64%) and PrUs
(32%)
Hydrosurgical Group:
-In 108 patients, 1
operative procedure was
sufficient to achieve an
adequately debrided
wound bed; 2 procedures
were required in 27 cases
& 3 procedures in 7 cases.
-Average time to achieve
complete ulcer
debridement wound bed
was 1.3  0.6 days,
compared to 4.3  3.9
days with the control
group
Hospitalization “reduced”
by a mean of 3 days
Bacterial burden ↓from
106 to 103
-MD rated the patient’s
pain levels VAS 4.3 ±. 9
;(87.8% of patients found
the pain to be comparable
to that of cleansing with
NS and gauze); only 10.5%
considered the procedure
painful and required local
anesthesia
-Healing rate 82%
-Minor bleeding stopped
spontaneously
-Patient satisfaction score
2.8 0.1
Control Group:
-VAS score rated by MD or
Nurse 5.3  2.1; none of
the patients required
general, nor local
anesthesia
- Minor bleeding stopped
-Healing rate 88%
95
Limitations
-Non-randomized
-? MD & Nurses rated
pain for the patients
-Pre & post treatment
bacterial levels not
provided for control
arm
-No statistical
comparisons
Treatment Technical Report
Reference
Steed D, Donohoe D, Webster
M, Lindsley L. Effect of
extensive debridement and
treatment on the healing of
diabetic foot ulcers. J Am Coll
Surg. 1996;183:61-4.
Williams D, Enoch S, Miller D,
Harris K, Price P, Harding KG.
Effect of sharp debridement
using curette on recalcitrant
nonhealing venous leg ulcers:
a concurrently controlled,
prospective cohort study.
Wound Repair Regen.
2005;13(2):131-7.
Type of Study
Randomized,
prospective,
double-blind,
multi-center trial
Concurrently,
controlled ,
prospective
parallel pilot study
(nonrandomized)
Sample
N=118 subjects with
diabetic neuropathic foot
ulcers (10 study centers)
Inclusion:
 Diabetic
neuropathic foot
ulcers
 Free of infection
on physical exam
& on plain
roentenograms
of the foot
 Ulcers secondary
to neuropathy
 Adequate arterial
blood supply
(TcPO2 of 30 mm
Hg
 Ulcer present for
at least 8 weeks
without healing
Exclusion:
 Poor diabetes
control
 Renal failure
 Abnormal liver
function
Exposed bone
N=53 patients with 55
chronic venous leg ulcers
(CVLU)referred to a
specialist wound center
in Cardiff, UK
-51 patients with 533
CVLU completed the
study
-Patients were recruited
from the 3 weekly clinics
in the study center
-Patients in the Study
group were selected by
Intervention(s)
Outcome Measures &
Length of Follow-up
-All patients received aggressive
debridement prior to randomization
-Repeated debridements of callus and
necrotic tissue were performed as
clinically indicated
-Any areas of undermining of skin
edges were unroofed to prevent
collection of bacteria & pus in the
wound
-Any clefts of granulation tissue were
saucerized for the same reason
-The influence of debridement was
evaluated by reviewing the records
of office visits where debridements
were performed
Recombinant human platelet-derived
growth factor (rhPDGF) (n=)
Placebo (Vehicle-Hydrogel) (n= )
Duration of treatment was until ulcer
completely healed or up to 20 weeks
Debridement Study Group (n=24
patients with 26 CVLU))
 Debridement was performed
by a single operator, using a
sharp circular curette (size 4 or
7) avoiding the sensitive ulcer
edges and was aimed at
removing slough, nonviable
tissue, and any avascular
fibrous tissue down to the
vascular base
 All patients received topical
anesthesia & the procedure
96
- -Ulcer measurements were taken
at 4 weeks before debridement, at
the time of debridement, and 4
and 20 weeks post-debridement.
-All patients were followed up to a
minimum of 20 weeks after
debridement
-Any complications were
documented
-Summary statistics were used to
describe the sample at baseline
and comparisons were made using
Chi Square and Student’s t-test
Results
Limitations
Patient satisfaction score
2.8 0.1
-Forty-eight percent of
subjects treated with rh
PDGF healed compared to
25% those who received
placebo (p=0.01)
-The mean percentage of
of office visits where
debridements were
performed was
comparable for the two
treatment groups: 46.8
percent (rhPDGF) and 48.0
percent (placebo)
-In general a lower rate of
healing was found in those
centers that performed
less frequent
debridements
-2 patients from the
debridement group had to
be excluded ; 1 secondary
to new onset dx of
leukemia and a second
patient who did not
adhere with compression
A total of 24 patients (26
ulcers) from the study
group and 27 from the
control group were
included in the analysis (1
patient contributed two
-Authors noted that this
is an ethically difficult
area to conduct
randomized controlled
clinical trials, and as
such, a nonrandomized
method was used.
-Secondary to a less
rigorous design, the
groups are less
homogenous than
expected and thus may
explain some of the
Treatment Technical Report
Reference
Type of Study
Sample
Intervention(s)
virtue of their wound bed
characteristics
-Patients in the Control
group whose wounds
were not debrided, were
selected from the patient
attendance list using
systematic sampling &
had wound beds with 1520% granulation tissue,
but no slough nor
nonviable tissue
was abandoned if the patient
experienced pain or
discomfort, a topical anesthetic
cream was applied to the
wound for 30-45 minutes at
the patient’s repeat visit to
complete debridement
 All but one patient had a single
episode of debridement
 A calcium alginate (Kaltostat)
was applied to control blood
loss after debridement
 Simple analgesics were
prescribed for pain relief
 Non- or low adherence dressing
were used
 4-layer bandage system was most
commonly used, although short
stretch bandages and tubular
bandages were also used if
patients could not tolerate the 4layer

Inclusion:
 Ulcers > 3
months duration
 Ulcers refractory
to conventional
treatment
 Ulcers with
absent
granulation tissue
or the presence
of nonviable
tissue
 Ulcers containing
yellow/white
slough with or
without
fibrous/scar
tissue
 Ulcers with
copious amount
of exudates
 Venous disease
confirmed
clinically and/or
by color flow
duplex imaging
(CDI)
 No evidence of
peripheral
vascular disease,
either on clinical
Non-debridement Control Group (n=
27)
 Non- or low adherence dressing
were used
 4-layer bandage system was most
commonly used, although short
stretch bandages and tubular
bandages were also used if
patients could not tolerate the 4layer
97
Outcome Measures &
Length of Follow-up
-Mean ulcer surface area and rate
of change were calculated using
mixed ANOVA, with post hoc
analysis assuming nonhomogenous variance. Two tailed
alpha was set at 0.05.
Results
Limitations
ulcers (different limbs) on
separate occasions to both
the study & control groups
variability in response.
-The Study group at
baseline had no
granulation tissue and
presented with slough,
while the control at
baseline had wound
beds with 15-20%
granulation and no
slough, nor non-viable
tissue
-The reduction in MSA
between groups over the
entire 20 week study
period did not achieve
statistical significance ,
sharp debridement was
clearly effective in
initiating the healing
process in the study group
-At 4 weeks postdebridement, the study
ulcers showed a 6 cm2
reduction in the MSA vs. a
1cm2 reduction in controls
(p=0.02).
-Infection rates in the
study group 4 weeks after
debridement were less
than the control group,
not statistically significant
Treatment Technical Report
Reference
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
examination or
on CDI
Exclusion:
 ABPI < 0.8
 Patients with
small (< 2.5 cm2 )
or very large
(>100 cm2 )
 Ulcers which are
clinically infected
with or without
microbiological
confirmation
 Ulcers associated
with mixed
etiology (e.g.
Arterio-venous
ulcers)
 Ulcers secondary
to systemic
causes such as
diabetes mellitus,
connective tissue
diseases (e.g.
Rheumatoid
arthritis) and
metabolic
diseases
 Suspicion of
malignancy
within the ulcer
Patients with concurrent
unrelated malignancy
98
Results
Limitations
Treatment Technical Report
Table 8. Dressings
References
Amione P, Ricci E, Topo F, Izzo
L, Pirovano R, Rega V, et al.
Comparison of Allevyn
Adhesive and Biatain
Adhesive in the management
of pressure ulcers. J Wound
Care. 2005;14(8 (Print)):36570.
Brown GS. Reporting
outcomes for stage IV
pressure ulcer healing: a
proposal. Adv Skin Wound
Care. 2000;13(6):277-83.
Brown-Etris M, Milne C,
Orsted H, Gates JL, Netsch D,
Punchello M, et al. A
prospective, randomized,
multisite clinical evaluation of
a transparent absorbent
acrylic dressing and a
hydrocolloid dressing in the
management of Stage II and
shallow Stage III pressure
ulcers. Adv Skin Wound Care.
2008;21(4):169-74.
Type of Study
Sample
Intervention(s)
Prospective
multicenter study
to examine the
delamination of
dressings (defined
as dressing falling
apart during wear
or removal or
presence of
dressing residue in
ulcer)
Retro
32 subjects with grade II
or III PrU randomized to
either Allevyn or Biatain
adhesive dressing
9 patients with 10 pelvic
stage IV PRU
Mean age 75
All male
NS gauze vs. Ca alginate followed by
hydrocolloid or foam
Eschar was sharply débrided and
slough was removed by WTD
Prospective
randomized
comparative
multisite clinical
evaluation.
A total of 72 patients
with stage II and shallow
stage III, minimally
draining pressure ulcer
were enrolled in the
study. 35 patients
received the Tegaderm
absorbent Clear Acrylic
Dressing (TAAD), and 37
received the hydrocolloid
dressing.
Patients were randomized to receive
either the TAAD or HD for the
treatment the pressure ulcer. Dressing
size was optimally matched to the
needs of the wound.
Wounds and dressings performance
were assessed on a weekly basis.
Evidence Level = I
99
Outcome Measures &
Length of Follow-up
83% of patients with Biatain
dressing had delamination
compared with 14% of Allevyn
Allevyn also better in handing
exudate, comfort, ease of
application, conformability and
removal
Results
Limitations
Weekly measurement of wound
length x width in cm
Small ulcers (18-24 cm) healed in
82-119 days with an average daily
reduction of 0.199 – 0.244 cm2
Medium ulcers (36- 51 cm) healed
in 91-176 days with an average
daily reduction of 0.264 -0.386 cm2
Large ulcers (80.5 – 117 cm)
healed in 102-233 days with an
average daily reduction of 0.502 to
0.789 cm2
End of treatment was
epithelialization
Dressing performance
assessments and patient comfort
were rated.
Dressing wear time was observed.
Wound healing was defined as
closer of the epidermis.
Patients were followed for up for a
maximum of 56 days or until their
ulcer healed.
Initial wound size
increased followed by
nonlinear reduction in
wound size
Median albumin rose from
3.10 to 3.4 with healed
wounds, Hgb rose from
10.4 to 11.8 with healing
Mobility changed from
bedfast or chair with max
assist to out of bed with
max assist, w/c with min
max and ambulatory
Subjects followed to full
healing
No discussion or results
on the difference in
healing based upon
topical treatment
The majority of
investigators assessment
favored the TAAD.
Consideration given
included the ability to
center dressings over the
ulcer (p = .005), ability to
assess the ulcer before
(p<.001) and after (p<.00)
absorption, barrier
properties (p=.039),
patient comfort during
removal (p<.001), overall
patient comfort (p<.001),
conformability before
(p=.026) and after (p=.001)
absorption, ease of
removal (p<.001), residue
TAAD has favored
performance over the
HD as standard
treatment for stage II
and shallow stage III
pressure ulcer.
Taken from abstract
Treatment Technical Report
References
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Results
in the wound (p=.002),
residue on peri-wound
skin (p<.001), and odor
after absorption (p=.016).
Overall satisfaction
favored the TAAD
(p<.001), and a high value
was placed on its
transparent feature (p<
.001). Mean (SD) wear
time for the TAAD was 5.7
(2.55) days compared with
4.7 (2.29) days for the HD
(p=.086). This one day
difference in wear time
was clinically noticeable by
the investigators (p=.086).
Wound closer for the 2
dressing groups was nearly
identical (p=.9627).
Carr RD, Lalagos DE. Clinical
evaluation of a polymeric
membrane dressing in the
treatment of pressure ulcers.
Decubitus. 1990;3(3):38-42.
Clinical evaluation
Diehm C, Lawall H. Evaluation
of Tielle hydropolymer
dressings in the management
of chronic exuding wounds in
primary care. Int Wound J.
2005;2(1):26-35.
1793 PrU patients
3 multicenter,
open-label, single
arm observational
phase IV study
70-day evaluation of
18 ulcers on 13 elderly
subjects with stage 1, II,
and III pressure ulcers.
The mean length of time
these ulcers had been
present prior
to the trial dressing was
144 days with 50% of the
ulcers [n - 9)
present for 75 days or
longer.
Physicians selected
patients for the study.
Inclusion:
4 weeks duration of
wound; therapy adjusted
based on severity of
symptoms and course of
healing.
No exclusion criteria
The findings of this study revealed
that greater than 60% of the ulcers
were completely healed while
greater than 94% were improved
during the study
Data were recorded at baseline and at
4 or 12 weeks.
Estimate of exudates were scored as:
1= none
2= little/small
3=medium/extensive
4=strong/entire area
Dressings changed 3 times a week
Changes in wound radius and % change
in wound area
Signs of infection
Level of exudate
100
Age mean 74.5 +/- 13.6
Gender female = 62%
At baseline:
Mean wound age = 2 months
Wound radius = 2.6 cm =/- 1/6
Wound depth = 38.6% deep, 9.2%
had wound pouches and deep
wound pouches
Infection = 47.2%
Exudate =- 36.7% little
28.4% medium, 14% strong
Odor + 23.9% none; 39.7% little;
25.4% medium; 9.5% strong
No control group for
comparison
Limitations
Treatment Technical Report
References
Type of Study
Sample
Intervention(s)
Wound odor
Portion of necrotic tissue
Portion of fibrous adhesion
Wound status = healed, improved,
unchanged aggravated
Cosmetic result = excellent, good,
moderate, unsatisfactory
Compliance with therapy = much
better, better, equal or worse
Outcome Measures &
Length of Follow-up
Necrotic tissue = 19.9 % none;
49.8% small; 25.6% extensive; 4.2
entire
Portion of fibrinous adhesion =
9.7% none, 53.9% small; 31.5%
extensive 2.3% entire
Results
Limitations
Complete healing rate
were the same at 8 weeks,
healing rates were
comparable at earlier time
points too. Collagen
healed 17% (6/35) within 2
weeks and 40% (14/35)
within 4 weeks,
hydrocolloid healed 20%
(6/30) within 2 weeks and
30% (9/30) within 4 weeks.
No differences in
healing time were
detected between
collagen and
hydrocolloid. Collagen
treatment was more
expensive than
hydrocolloid treatment.
Stratification of initial
ulcer depth or stage
should be considered.
After 4 weeks: wound radius was
67.4% smaller and 77.9%
reduction in wound size
38.9% PrU healed; 55.9%
improved; 3.3% unchanged and
0.2 aggravated
After 12 weeks: 79.1% reduction in
wound radius and 87.5% reduction
in wound size
57.8% healed, 39.3% improved;
2.5 unchanged and 0.2 aggravated
Cosmetic results of healed ulcers
were excellent or good in 96.9%
Withdrawals from study were
4.5% for insufficient efficacy,
intolerance and worsening of the
wound
Graumlich JF, Blough LS,
McLaughlin RG, Milbrandt JC,
Calderon CL, Agha SA, et al.
Healing pressure ulcers with
collagen or hydrocolloid: a
randomized, controlled trial. J
Am Geriatr Soc.
2003;51(2):147-54.
Randomized,
single-blind,
controlled
65 patients-residents
with stage II or III
pressure ulcers: 35 were
allocated to topical
collagen dressing and 30
were allocated to topical
hydrocolloid e.
Sample assigned to treatment of 1:1
ratio to daily type I collagen or twiceweekly hydrocolloid.
Evidence Level = II
Adverse effects occurred in 2.9%
and were pain, general intolerance
and itching
Primary efficacy endpoint was the
proportion of pressure ulcers
completely healed within 8 weeks
of randomization. Secondary
efficacy endpoint was time of ulcer
healing, area healed per day, and
linear healing of wound edge.
Study intervention duration was 8
weeks.
There was no significant
difference (log rank 0.68, P
101
Treatment Technical Report
References
Type of Study
Sample
Harding K, Cutting K, Price P.
The cost-effectiveness of
wound management
protocols of care. Br J Nurs.
2000;9(19 Suppl): S6, S8, S10
passim.
Cost-effectiveness
study.
Total of 15 pressure sore
studies involving 519
wound, and 12 leg ulcer
studies involving 843
ulcers were used I pooled
analysis.
Kaya AZ, Turani N, Akyüz M.
The effectiveness of a
hydrogel dressing compared
with standard management
of pressure ulcers. J Wound
Care. 2005;14(1):42-4.
Prospective
random
assignment to
Treatment groups
27 subjects, all spinal
cord injured
With 49 PrU
Intervention(s)
Outcome Measures &
Length of Follow-up
Protocols of care were derived for
venous leg ulcers and pressure source
from a detailed literature search of
published clinical research,
supplemented where necessary by the
input of a panel of care experts. This
was followed by the development of
cost-effectiveness models comparing
the different protocols of care. Three
dressing interventions were compared:
the modern hydrocolloids, Traditional
gauze, a skin replacement approach.
Hydrogel gel sheet
Povidone –iodine soaked gauze
24 males
21 had complete SCI 4
were incomplete injury
Each pressure sore protocol
incorporates 3 aspects of care:
1. assessment
2. wound care
3. care of infection.
Location of ulcer
Rate of healing (cm2 of surface
area/days to heal), healing time to
epithelialization
and treatment time
Healing time was computed at
discharge in nonhealed wounds by
subtracted by current size of the
ulcer from the baseline
Sacral ulcers
6 in control
7 in treatment
Ischial ulcers
3 in control
102
Results
=.409) in time to complete
healing between collagen
and hydrocolloid
treatment.
There were no significant
differences between
collagen for any primary
and secondary efficacy
endpoint. Baseline
measures of ulcer stage,
depth, duration, and area
were only covariates
associated with complete
healing within 8 weeks
(p<.10). only ulcer depth
(odd ratio = 0.56, 95% CI =
0.38-.81, p =.002)
remained a significant
predictor of complete
healing within 8 weeks.
Hydrocolloid was the most
cost effective treatment. It
was approximately 50%
more cost-effective than
gauze. Comparing cost
effectiveness of two
modern hydrocolloids,
Granuflex was 50% more
cost effective than
Comfeel.
Results reported on all
ulcers, not subjects
Baseline age, Hgb,
Albumin, TLC, ulcer size
and grade were not
statistically significant
different between groups
Mean healing rate was
higher in treatment (0.02
to 0.36) than in control
(0.03 to 0.23), but not
statistically sig
Limitations
No information about
clinical effectiveness at
all. *
The stats in this study
are incorrect. We have
reported what we feel is
accurate.
It is odd that the iodine
did not retard wound
healing
Treatment Technical Report
References
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Results
Limitations
6 in treatment
Heel ulcers
2 in control
6 in treatment
Trochanter
4 in control
3 in treatment
Iliac crest
4 in control
0 in treatment
Knee
2 in control
1 in treatment
Head of fibula
2 in control
0 in treatment
Lateral malleolus
2 in treatment
0 in control
Dorsal foot
0 in treatment
1 in control
Kloth LC, Berman JE, DumitMinkel S, Sutton CH, Papanek
PE, Wurzel J. Effects of a
normothermic dressing on
pressure ulcer healing. Adv
Skin Wound Care.
2000;13(2):69-74.
Before after trial
Radiant heat
applied through
semi occlusive
dressing v
standard care
Spinal cord injury and
geriatric unit at VA
20 inpatients with 21
stage II and IV PrU
6 wound control only
15 wounds treatment
group
Semi occlusive heated dressing applied
to 15 stage III and IV PrU or 4.5 hours
M-F for 4 consecutive weeks At other
times receives standard care
4 weeks
Surface area
Wounds treated with heat
healed significantly faster
Small sample size
Kloth LC, Berman JE, Nett M,
Papanek PE, Dumit-Minkel S.
A randomized controlled
clinical trial to evaluate the
effects of noncontact
normothermic wound
therapy on chronic fullthickness pressure ulcers. Adv
Skin Wound Care.
2002;15(6):270-6.
Prospective,
randomized
VA and 7 LYC
40 inpatients with 43
Stage II and IV PrU
Of 43 wounds 6 control ad 7 treated
with NNWT 21 total wounds
treatment with NNWT and 22 standard
care
Between 3 – 11 weeks of
treatment
Wound healing
No differences initial
wound surface area
Length of time wounds
treated considered the
NNWT was significantly
better
Small sample size
Matzen S, Peschardt A,
Randomized
Hydrogel 17
Dressing changed daily
Time of healing
Saline need more weekly
Small sample size
103
Treatment Technical Report
References
Type of Study
Sample
Intervention(s)
Alsbjorn B. A new amorphous
hydrocolloid for the
treatment of pressure sores:
a randomised controlled
study. Scand J Plast Reconstr
Surg Hand Surg.
1999;33(1):13-5.
control study
hydrogel v wet
saline gauze
Wet saline 15
Wounds sacrum or
trochanter areas
Stage II-IV non-infected
Measurements 1X/week
8 week, open
randomized.
multicenter
controlled study
38 residents
18 randomized to soft
silicone dressing, 20 in
the hydropolymer
dressing
Randomized open
label mutecentered parallel
group
13 centers with VLU (n=
71) and stage III/IV PrU
(n=28), wounds were not
infected (no local sign of
infection and not on ABs)
Inclusion Criteria:
continuous pain,
erythema, edema, heat
and moderate to high
levels of serous exudate
Baseline PrU
Duration of treatment
group 4.4 =/- 3.7 months
(median 2.0)
Control group 3.7 =/- 6.0
months
(median 2.0)
Area 22.5 +/- 2.1 cm in
(median 15.6)
Control 22.4 +/- 25.5 cm
(median 18.7)
Severity score
Treatment 17.6 +/- 3.0
Outcome Measures &
Length of Follow-up
Followed 12 weeks or until healed
Results
Limitations
débridement than
hydrogel
Rate of healing was
significantly better
hydrogel
Evidence Level = II
Meaume S, Van De
Looverbosch D, Heyman H,
Romanelli M, Ciangherotti A,
Charpin S. A study to
compare a new self-adherent
soft silicone dressing with a
self-adherent polymer
dressing in stage II pressure
ulcers. Ostomy Wound
Manage. 2003;49(9):44-51.
Evidence Level = II
Meaume S, Vallet D, Morere
M, Téot L. Evaluation of a
silver-releasing hydroalginate
dressing in chronic wounds
with signs of local infection. J
Wound Care. 2005;14(9):4119.
Aqua Cell
8 (44%) of ulcers in soft silicone
dressing group and 10 (50%) in the
hydropolymer dressing group
healed.
No differences in the signs of
inflammation, amount of exudate,
odor of exudate or leakage were
observed.
Damage to peri-wound skin were
less common in the soft silicone
dressing during the weeks
Random assignment to silver-releasing
hydroalginate or Ca alginate dressing
Assessed wounds daily x 14 days and
then weekly x 2 weeks
Assessment = modified ASEPSIS index
Débrided of necrotic tissue with
surgical or mechanical methods at
admission and then prn
Global wound severity score and
area tracings were recorded
weekly
Severity score was the % of wound
affected by exudate, odor, necrotic
tissue, color, epithelium
ASEPSIS index is points given for %
of serous exudate, erythema,
purulent exudate and separation
of deep tissue
Other parameters measured
during the study were antibiotics
during the study, I&D,
debridement under general
anesthesia, cultures and prolonged
hospitalization
Nothing provided on R/V on these
measures
104
PrU decreased in size
Treatment group by -7.2
+/-9.0 cm
Control -0.8 +/- 10.0 cm
p = .117
Healing rate in 4 weeks
Treatment = .26 +/- 0.32
Control = .03 +/- .36
p = .024
% wound reduction at
week 4
Treatment = -31.6 +/- 38.1
Control = -13.9 +/- 50.3
p = .923
Wound severity scores at
week 4 (mean)
Treatment = 12.1 +/- 3.9
Control = 13.8 +/- 4.3
p = 0.171
Groups were the same
at the beginning
No information on who
completed the
assessments (e.g.,
wound nurse)
Stat sig lost due to wide
variation in SD
Wound severity score,
which was most subject
to infections was the
only statistically
significant finding
Treatment Technical Report
References
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
(median 17.0)
Control 17.4 +/- 3.7
Results
Limitations
Absolute wound severity
score at week 4
Treatment -5.5 =/- 4.2
Control -3.6 +/- 5.0
P = .063
% decrease in wound
severity score
Treatment -30.7 +/- 23.0
Control -17.5 +/- 32.0
P .034
Dressings best for wounds
at high risk of infection
Moore OA, Smith LA,
Campbell F, Seers K, McQuay
HJ, Moore RA. Systematic
review of the use of honey as
a wound dressing. BMC
Complement Altern Med.
2001;1:2-.
Systematic
reviews of 7 RCTs
in burns and
infected surgical
wounds
Honey compared to
amniotic membrane,
potato peels (N =20) and
polyurethane film
Time to healing
Infection rate
105
Infected postoperative
wounds comparing honey
to antiseptics and
syste4mic antibiotics
showed much shorter
times for healing,
eradication of infection
and shorter hospital stay
for honey. Portion of
wounds healed without
dehiscence or resuturing
was 22/26 (85%)
compared to 12/24 with
antiseptic.
Moderate to severe burns
showed honey to be less
effective than tangential
excision and grafting. Half
of the patients treated
with honey eventually
needed eventual skin
grafting.
Patients with partial or
superficial burns treated
with honey were
significantly shorter times
to healing than film
dressings, amniotic
Time to healing was
shorter for honey than
all the other treatments
Treatment Technical Report
References
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Results
Limitations
membrane, potato peels
or Silvadene.
Nisi G, Brandi C, Grimaldi L,
Calabrò M, D'Aniello C. Use of
a protease-modulating matrix
in the treatment of pressure
sores. Chir Ital. 2005;57(4
(Print)):465-8.
RCT
40 subjects in each group
PrU cultured, débrided,
disinfected with Betadine
which took from1-6
weeks
Once the wound was completely clean,
group A was treated with 2 or 3 times
weekly collagen with a cover dressing
of hydropolymer patch. Group B was
treated with daily wash with 50%
Betadine, and packed with viscose
rayon gauze and hydropolymer cover
dressing.
Method of measuring wound healing
not provided.
Pieper B, Sugrue M, Weiland
M, Sprague K, Heiman C. Risk
factors, prevention methods,
and wound care for patients
with pressure ulcers. Clin
Nurse Spec. 1998;12(1):7-12.
Prospective,
Descriptive
N= 694, 71 had PrU
Data collection from medical records
on types of dressings
The top three dressings used for
the treatment PrU were
hydrocolloid (n = 52), WTD (n= 38)
and transparent films (n = 16)
Takahashi J, Yokota O,
Fujisawa Y, Sasaki K, Ishizu H,
Aoki T, et al. An evaluation of
polyvinylidene film dressing
for treatment of pressure
ulcers in older people. J
Wound Care.
2006;15(10):449.
Prospective, open
label,
nonrandomized
control trial of
food wrap (a semi
occlusive dressing)
53 patients from 2
geriatric wards in Japan
of Stage III or IV PrU,
using only the most
severe ulcer for inclusion.
Only yellow PrU studied
because they are highly
exudating
Control was NS cleanser and on yellow
phase ulcers dry gauze and iodinesugar (U-Pasta), iodine-cadexomer
paste (Cadex), Silvadene or enzymes
was used on the wound. When the
wound was red, the topical changed to
alprostadil alfadex (Prostandin),
tocoretinate (Olsenon) or bucladesine
(Actosin).
Wounds that needed debridement
were débrided .
Treatment was to cleanse with NS and
cover with non-sterilized PVI film
dressing and closed with tape; the
dead space was not packed. Excess
exudate was drained. (This procedure
was used on ulcers of any stage or level
of inflammation. Dressings were
DESIGN, a tool designed in Japan
was used to measure depth,
exudate, size, infection,
granulation, necrosis + pocket
undermining. Total score ranges
from 0-29, tool has high r/v and
was compared with PSST
Evidence Level = II
26 control
27 experimental
1 treated in the
experimental group got
well and dropped out; 18
subjects dropped out (7
in the experimental and 9
106
DESIGN was used at baseline and
every 4 weeks.
Incidence of adverse events was
also monitored including local
wound infection that developed
into cellulitis, maceration, and
development of eschar .
Low Norton scores were
correlated with increased
severity of ulcers.
Ulcers healed in 90% (N=
36) of group A in 2-6
weeks. Time to healing
group B was 2-8 weeks.
Wound healing rates:
36/40 [90%] with protease
modulating matrix v 28/40
[70%] with standard
dressing; P = 0.59).
Group A was hospitalized
360 days compared to
1164 days of
hospitalization in group B
Comparison of groups at
baseline not provided
At baseline, the groups
were the same for gender,
age, mental disorders,
Braden score, stage of PrU,
surface area, location,
state of ulcer (with
cellulitis or undermining)
or systemic disease.
Patients were in poor
condition at the start of
the study. The film was
superior to standard
treatment in stage III
and IV ulcers in
inflammatory phase.
Final sample was 25 in
experimental and 24 in
control group
Systemic infection
independent of the wound
occurred in 8 of
experimental (32%) and 6
(25%) of control group.
From Reviewers:
When the adverse
events were reported in
this study, the
denominator was the
enrolled number, not
the number who
completed the study.
The experimental
Treatment Technical Report
References
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
in the control group ) due
to death
And 2 in the
experimental group were
transferred.
changed at least daily. If local or
systemic infection developed, the
wound was débrided.
All patients risk was controlled and
included mattresses and chair
cushions.
Results
Limitations
These patients Braden
were less than 10 and they
died before 12 weeks
dressing relied on
autolytic debridement
which
immunocompromised
patients may not have
By weeks 8 and 12, the
experimental group had
statistically significant
improvement in DESIGN
tool score (median in
experimental 11 and
control was 7)
Surface area mean
16.4 +/- 27.6 cm2
experimental
22.6 +/- 27.9 cm2 control
Maceration of the heel
occurred in patients in the
test group, although not
statistically significant
Complete healing was
seen in 5 (20%) of
experimental and 2 (8%) of
control.
Thomas DR, Goode PS,
RCT
41 residents of a SNF and
Randomized to daily application of
107
Weekly measurement of wound
Adverse effects (infection,
maceration and eschar)
was statistically significant
lower in test group (p <
0.03) total
Infection was 4/25 in
experimental group
and 4/24 control (p = NS)
Maceration was 3/25 and
0/25 (p.= 235)
Eschar 0/25 in
experimental group and
6/24 in control group (p=
0.010)
Surgery 5/25 experimental
and 12/24 in control p
=0.039
Males 53%
Results in wound
Treatment Technical Report
References
Type of Study
LaMaster K, Tennyson T.
Acemannan hydrogel dressing
versus saline dressing for
pressure ulcers. A
randomized, controlled trial.
Adv Wound Care.
1998;11(6):273-6.
Sample
Intervention(s)
HHC enrolled , 11
dropped
AceMannan hydrogel or NS gauze for
daily dressing changes
Inclusion Criteria: stage
II-IV ulcers (1 per subject)
Ulcer area > 1.0 cm2
Exclusion:
Non-pressure ulcers
sinus tracts or
undermining > 1 cm
Clinical infected wounds
Use of other ulcer meds
or steroids
Severe generalized
medical conditions
Survival likely less than 6
months
HIV positive
Drug or ETOH addict
Pregnant/ nursing/or
likely to get pregnant
Cancer or on
chemotherapy
Outcome Measures &
Length of Follow-up
surface area with tracing and
photograph
Data collected for 10 weeks unless
healing occurred before
Retrospective
chart review of
1891 patients with
4200 wounds.
3969 wounds
Charts of nursing home
patients in Florida, MDS
data used
Limitations
Mean age 76 +/- 12 (range
35-97 years)
Caucasian 53%
Black 47%
healing were the same
Stage II 47% (n=15)
Stage III 43% (n= 20)
Stage IV 10% (n = 6)
Mean area of ulcers was
7.6 +/- 7.8 cm2
16 (53%) were
experimental group
14 (47%) were control
group
Rate of healing for both
groups and for stage II and
III
None of the stage IV ulcers
healed
Complete healing was in
19/30 ulcers (63%) in the
10 week period
The odds of healing were
greater in Caucasians,
stage II ulcers and those
with smaller surface areas.
11 subjects dropped; 4
experimental and 2
control died, 1 subject in
each group showed
worsening of the study
ulcer and was
terminated, 1 subject in
each group was
hospitalized and
dropped, 1 subject in
control group was
dropped for protocol
violation
Therefore 30 subjects
were analyzed
Viamontes L, Temple D,
Wytall D, Walker A. An
evaluation of an adhesive
hydrocellular foam dressing
and a self-adherent soft
Results
Mean age was 82.5 (range 29-106);
55% of patients had more than one
wound and 2% had 11 or more wounds
Skin stripping occurred during
dressing removal in less than 1% of
each group
Infection was more frequent in the
108
Unit of analysis was the
wound
How did they keep
moist gauze moist?
Treatment Technical Report
References
silicone foam dressing in a
nursing home setting. Ostomy
Wound Manage.
2003;49(8):48.
Yastrub DJ. Relationship
between type of treatment
and degree of wound healing
among institutionalized
geriatric patients with stage II
pressure ulcers. J Case
Manag. 2004;5(4):213-8.
Evidence Level = IV
Yapucu Güneş U, Eşer I.
Effectiveness of a honey
dressing for healing pressure
ulcers. J Wound Ostomy
Continence Nurs.
2007;34(2):184-90.
Type of Study
were pressure
ulcers (95%), 18
(>1%) stage I;
1856 (47%) stage
II; 1539 (39%)
stage III; 194 (5%)
stage IV.
Purpose was to
compare
performance of
foam and silicone
dressings
Random
assignment
polymen
(polymeric
membrane
dressing vs.
antibiotic
ointment and dry
dressing
RCT over 5 weeks
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
silicone dressed wounds (23%)
compared to 9% of the foam
Results
Limitations
44 long term care
residents in NY, CVA
patients with Stage II
PrUs
Random assignment to groups All had
same other care Weekly PrU rounds
used PUSH tool
4 weeks
Outcomes rate of healing
PolyMem dressing showed
improved wound healing
Small sample size
26 patients with 68 stage
II or III PrU with more
than 2 months Initial
sample dropped 3 DM, 4
terminal patients and 1
refusal
Randomly assigned to group by age,
sex, and ulcer surface area
15 patients with 25 ulcers treated with
honey. Honey used was unprocessed
(raw, natural, organic and
unpasteurized) with a minimum
inhibitory concentration of 3.8%.
Honey was sterilized with radiation.
Ulcer cleansed with NS. Honey applied
to a gauze dressing, 20 ml for a 10 x 10
cm wound. Same cover dressing as
control. Dressing change frequency not
clear (1 or 2 days)
PUSH measurements
Acetate tracings for area
Mobility levels assessed via Braden
subscale
Age Treatment group 65.8
+/-6.3
Age con group 65.6 +/- 5.5
Ulcers in treatment group
12 sacrum
3 shoulder
5 trochanter
5 heel
Ulcers in con group
12 on sacrum
4 shoulder
2 trochanter
7 heel
At baseline, no sig diff in
age, gender, BMI, mobility
level, Hgb and stage
between groups
Honey produces H2O2
and has antioxidants in
it. Honey also has antiinflammatory product.
Odor is reduced by
providing an alternative
product for bacterial
metabolism that yields
lactic acid rather than
ammonia, amines and
sulfur which are
odorous.
11 patients with 25 ulcers were
cleansed with ethoxy-diaminoacridine
(EDC) followed by nitroflurazone
(Furacin) cream with dressings soaked
with EDC and covered with
semipermeable thin films, Dressing
changed daily or prn soilage
Each group had the same pressure
redistribution and a turning and
109
Treatment continued until the
wound healed or a maximum of 5
weeks
PUSH scores showed
healing, Treatment group
showed 4 times the
healing rate. Healing rate
at 5 weeks in honey group
was 12.62 +/- 2.15 PUSH
Treatment Technical Report
References
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
repositioning program
Wanner MB, Schwarzl F,
Strub B, Zaech GA, Pierer G.
Vacuum-assisted wound
closure for cheaper and more
comfortable healing of
pressure sores: a prospective
study. Scand J Plast Reconstr
Surg Hand Surg.
2003;37(1):28-33.
Results
Limitations
score compared to in
control group of 6.55 +/2.12. p < .001
VAC compared to
wet-dry
Randomized trial
22 patient grade 3
(Europe) pelvic region
Did debridement then randomized to
either VAC or wet-dry gauze with
ringers
10 days and 7 days
Reference
Type of Study
Sample
Intervention(s)
Baxter H. A comparison of
two hydrocolloid sheet
dressings. Br J Community
Nurs. 2000;5(11):572.
Clinical essay.
Ten patients: five
patients were tried with
Duoderm extra thin and
five patients were tried
with Tegasorb thin.
Tegasorb thin and Duoderm extra thin
were essayed and compared in the inpatient and outpatient clinics. Both
dressings were tried on patients with
leg ulcers, sacral sores, and trauma
wound. Both dressings were also
applied to the tissue joints of a tissue
viability nurse and observed for
performance and durability over a
working day.
Outcome Measures &
Length of Follow-up
Staff and patients were asked their
opinion of two dressings. The two
dressings were compared for the
ease of application and removal,
conformability, wear time, cost,
fluid handling capacity, and patient
comfort.
The comparison was not
conducted on a scientific basis and
confers only anecdotal
observations of the author.
Complete healing in 5
ulcers in 5 weeks in
Treatment group, no PrU
in control group healed
completely
No difference
Small, many excluded
Couldn’t use VAC with
incontinence patient
Indirect Evidence
110
Results
Limitations
Application was easy on all
wounds, some preference
expressed by clinicians to
the film border and shape
of the oval Tegasorb
dressing for sacral
wounds.
Tegasorb thin was more
easily removed.
Duoderm extra thin was
found to melt in areas
leaving patches of
adhesive and dressing on
the patient’s skin. It is also
found to be pulled apart,
coming off in several
pieces.
Dressing under
compression bandaging
for superficial leg ulcers
were left in place for 7
The two dressings are of
low fluid handling
capacity.
Both dressings
performed well and
were found to be
effective dressing for
superficial, low exudate
wounds.
Tegasorb thin was
found to be easier to
remove, but required
more practice to apply
to areas such as elbow
and heals.
Duoderm extra thin is
slightly less expensive
per unit, but had a
greater tendency for the
edges to roll up.
Patients found the
Treatment Technical Report
Reference
Bergemann R, Lauterbach
KW, Vanscheidt W, Neander
Type of Study
Cost analysis
prospective
Sample
5 patients with 4 PrU, 1
leg wound
Intervention(s)
Outcome Measures &
Length of Follow-up
Cost data included material cost for
wound dressings and time
111
Results
Limitations
days. Dressing change
times ranged from 1-5
days for other wounds.
Duoderm extra thin was
easy to apply and
conformed extremely well
to an elbow joint, while
the oval Tegasorb thin was
more difficult to apply.
Duoderm’s edges had
occurred and the dressing
had started to stick to
clothing, while the
Tegasorb was easier to
remove with less trauma
and pulling of the skin with
some discomfort.
No differences were
observed in the fluid
handling or healing
properties of the two
dressings, some
maceration of the
surrounding skin was
observed with both
dressings when used in leg
ulcers under compression
for 7 days.
No adhesive reactions
were observed with either
wound dressing. Both
dressings were
comfortable and
acceptable for most
patients with some
discomfort felt with the
removal of the dressings.
The Tegasorb thin range is
slightly more expensive
per unit than the Duoderm
extra thin range. The cost
is only a few pence per
dressing.
Gauze dressings with
Ringer’s solution were 20-
dressings comfortable
and acceptable with
pain reduction reported
in superficial pressure
sours and trauma
wounds.
Gauze is expensive
when time is factored
Treatment Technical Report
Reference
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
KD, Engst R. Economic
evaluation of the treatment
of chronic wounds:
hydroactive wound dressings
in combination with
enzymatic ointment versus
gauze dressings in patients
with pressure ulcer and
venous leg ulcer in Germany.
Pharmacoeconomics.
1999;16(4):367-77.
Burrell RE, Heggers JP, Davis
GJ, Wright JB. Efficacy of
silver-coated dressings as
bacterial barriers in a rodent
burn sepsis model. Wounds.
1999;11(4):64-71.
Dowsett C. The use of silverbased dressings in wound
care. Nurs Stand.
2004;19(7):56-60.
Experimental
120 Sprague-Dawley rats
1 patient with a grade IV
PrU, draining pus and
odorous
A virulent strain of Pseudomonas was
serially diluted into 5 solutions and
inoculated onto burn wounds on
Sprague-Dawley rats.
Groups included a control group of
gauze with mesh, and a group with the
same dressing saturated with silver
nitrate or nanocrystalline silver coated.
A group that had no dressing and one
group were infected but no dressing.
Time of study was 15 days
Aqua Cel with Ag placed in wound
cavity
Complete wound healing at 9
months
112
Death, mean days to death were
outcomes
Results
Limitations
40 cents per dressing and
time required to changed
was 22 minutes using 2
nurses (cost was $44.88
for 2)
Impregnated gauze (50
cents to $1.00 with 2
nurses for 20 minutes
each.
Ca alginate dressings also
took 2 nurses for 20
minutes
Cutiniova hydroactive
dressing took one nurse 26
minutes and cost $26.52
Burn control (no dressings
and no infection)
20/20 all survived.
Infected group (all
inoculated, no dressing)
1/20 survived, mean
days to death 6.2
Dry dressing group
0/20 survived, mean days
to death = 4.8
Silver nitrate group
0/20 survived, mean days
to death = 5.9
Nanocrystalline drugs
34/40 survived
Mean days to death 10.2
into cost.
Dressings reduced from
daily to 3 times per week
Acticoat is a low
adherent primary
wound dressing,
nanocrystals release at
70 mg/l. Has the most
rapid effect
AquaCel Ag is a
hydrofiber with ionic
silver, dressing is
absorbent
Contreet is a
polyurethane foam,
silver is released when
While this is a burn
animal model, it shows
the efficacy of Ag on
Pseudomonas when
delivered by dressings
Treatment Technical Report
Reference
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Results
Limitations
dressing contacts
exudate. Slower onset
of action than Acticoat
Actisorb Ag is activated
charcoal with metallic
silver, broad spectrum
including fungi and
bacteria. Odor is
reduced with activated
charcoal.
Urgotul SSD is a
hydrocolloid with silver
sulfadiazine
Avance is a
polyurethane foam with
a silver complex.
Silver stains the wound,
but is removable with
cleansing. No known
bacterial resistance.
Gray M, Jones DP. The effect
of different formulations of
equivalent active ingredients
on the performance of two
topical wound treatment
products. Ostomy Wound
Management. 2004;50(3):34.
Kerstein MD. Unexpected
economics of ulcer care
protocols. South Med J.
2004;97(2):135-6.
Subset of human
patients with
experimentally
created wounds in
a larger study that
included
hydrocolloid and
saline dressings
This was
comparing balsam
of Peru, castor oil
and trypsin
ointment
(Xenaderm) and
balsam of Peru,
castor oil and
trypsin spray
(Granulex)
Literature review.
Subjects were at least 65
years old
Inclusion: over age 65
Exclusion: not taking
medications that could
affect coagulation and no
wounds or scars on thigh.
36 randomized
controlled studies focus
on saline, hydrocolloid,
and human skin
construct.
Partial thickness wound (6 mm
diameter) created on upper outer thigh
with ERbium-YAG Laser
Random assignment to spray,
ointment or saline dressings
Wounds treated with
ointment had less
erythema, edema,
scabbing and greater
healing
Not a pressure ulcer
study
Among the key points
appeared in the literature:
at least 12 weeks are
required to achieve 50%
healing of wound (10X10
Decisions regarding
ulcer treatment
protocols should not be
relayed solely on the
initial cost of materials.
Erythema, scabbing, edema and reepithelialization measured every other
day
Randomized controlled studies
conducted between 1984 and 1999
were reviewed by a panel of wound
care experts.
113
Cost of managing chronic ulcers,
including both venous leg ulcers
and decubiti.
Treatment Technical Report
Reference
Type of Study
Sample
Kohr R. Clinical focus: wound
care. Moist healing versus
wet-to-dry. Can Nurse.
2001;97(1):17-9.
Case study
1 case study
Morris L. Clinical efficacy of CView transparent film wound
dressing. Br J Nurs.
2001;10(9):616-20.
Case studies
5 of mixed wounds, 2
were PrU on sacrum
Motta GJ, Milne CT, Corbett
LQ. Impact of antimicrobial
gauze on bacterial colonies in
wounds that require packing.
Ostomy Wound Manage.
2004;50(8):48-62.
Perspective
randomized 5
week controlled,
open label,
multicenter study
18 year or older, wounds
required packing,
necrotic tissue <20%
No antibiotic therapy
24 total (12 each group)
11 completed treatment
group (4 PrU) and 10
control (3 PrU)
Schulze HJ. Clinical evaluation
of TIELLE* Plus dressing in the
management of exuding
Compared gauze
dressing with
antimicrobial to
control gauze
without antimicrobial in PrU,
surgical wounds
and diabetic foot
wounds
2121 patients with
wounds; 20.7%
PrU
Intervention(s)
Outcome Measures &
Length of Follow-up
Results
Limitations
cm) when using
hydrocolloid dressing plus
Hydrocolloid dressing is
the most cost effective
when considering the
labor intensive of
dressing changes 3-4
times per day.
WTD cost $2.50 for
dressings and $20 for
nursing = 675 (we
recomputed for 9 days =
$607.50
MWH $8.00 for product
plus $20 for nursing =
$84
Cost comparison of tid WTD for 3
days to hydroactive gel with one
occlusive dressing for 3 days
Case study patient had
decreased analgesic needs
and less home care needs
(q 4 days) with healing
time at 4 weeks post
discharge
C view transparent film applied to
necrotic eschar in one patient, and a
stage I on the sacrum
Examined dressings for wear time,
comfort, wrinkling, peri-wound
maceration, sensitivity reaction,
and performance.
Ability to protect skin from shear
and friction
as a secondary contact layer
Economic factors also examined
Wound irrigation with S and lightly
packed wounds with group’s assigned
dressing both groups.
Secondary dressing applied both
groups
Wound size and 1 wound
assessment parameters using
WASPT, swab cultures for bacterial
colony counts
Wear time 3 days
Comfort = unknown
Wrinkling = none
Periwound maceration =
none including the one
patient with eschar
treated with hydrogel
Sensitivity = none
Staff liked the distensibility
of dressing, stayed on
longer so was less
expensive, easily to apply
and remove
5 week
Lower bacterial count I
antimicrobial gauze group
No data on healing rates
Within the 12 week observation
period, 43% of the wounds healed
and 50.4% were improved
114
From abstract
Mixed types of wounds,
very small sample
Treatment Technical Report
Reference
Type of Study
chronic wounds. Br J
Community Nurs. 2003;8(11
Suppl):18-22.
Observed for 12
weeks after
changing to Tielle
Sibbald RG, Browne AC,
Coutts P, Queen D. Screening
evaluation of an ionized
nanocrystalline silver dressing
in chronic wound care.
Ostomy Wound Manage.
2001;47(10):38-43.
Uncontrolled ,
prospective openlabel study
Van der Weyden EA. The use
of honey for the treatment of
two patients with pressure
ulcers. Br J Community Nurs.
2003;8(12):S14-20.
Case studies
Voigt DW, Paul CN. The use of
Acticoat as silver impregnated
telfa dressings in a regional
burn and wound care center:
the clinicians view. Wounds.
2001;13(2):11-22.
Case review of 10
patients (but chart
data only lists 7
patients)
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Results
Limitations
29 patients with chronic
nonhealing wounds
9 DFU
6 VSU
2 PrU
12 Misc
PrU patients were
admitted if they had less
than 30% healing in 4
weeks, a
therapeutic surface
Hgb > 8.0
Albumin > 1.2
No cardiac or kidney dx
2 patient with PrU
Appears that silver dressing were
applied, no information on frequency
or use of a control group. There is a
note that this is a 4 arm study.
Wound tracing and exudate
(amount, type and odor) were
assessed
Granulation tissue noted to be
firm, friable, or excess
Qualitative cultures at baseline,
weeks 2 and 4
PrU (N = 2) had decreased
exudate and size of ulcer
Silver is potentially safe
topical wound
treatment but does not
control infection in
deeper tissues
Alginate dressing with honey (Apinate
made in New Zealand)
Serial monitoring of wound size
and photos
Odor and pain was noted
Lateral ankle initially 4 x
2.5 healed in 11 weeks,
reduction in odor and pain
Sacral was initially 2 x1
with 6 x 5 erythema,
healed in 8 weeks,
reduction in odor
Honey was used as an
autolytic débrider
7 patients per chart with
pressure ulcers
ActiCoat used with no discussion of
prior treatment or general treatment
of patient
Wound volume
Duration
Time in days to heal
Volume of healing over time
PrU in 5 patients who died
prior to being healed
Ave starting volume 493
mm3
Ave max volume 957
mm3
Duration prior was 3.8
months
Treated for average of 70
days
Wound volume
decreased by 564 mm3
(due to increase in initial
wound size after treating)
Ulcers that healed were
significantly smaller
Patients reported less
odor from ulcers
Surface flora reduced, but
qualitative wound cultures
did not show reduction in
organisms and still
required systemic therapy.
Followed for 6 weeks
PrU in 5 patients who did
not die prior to being
healed
115
Treatment Technical Report
Reference
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Results
Ave starting volume 196
mm3
Ave max volume 957
mm3
Duration prior was 7.0
months
Ave time to heal
wounds was 35 days
Wound volume decreased
by 564 mm3 (due to
increase in initial wound
size after treating)
116
Limitations
Treatment Technical Report
Table 9. Assessment and Treatment of Infection
Direct Evidence
Reference
Gunes UY, Eser I.
Effectiveness of a honey
dressing for healing pressure
ulcers. J Wound Ostomy
Continence Nurs.
2007;34(2):184-90.
Type of Study
Sample
Randomized
clinical trial
26 patients: 15 patients
with 25 PrU treated with
honey vs. 11 patients
with 25 PrU treated with
ethoxy-diaminoacridine
plus nitrofurazone
Retrospective
168 surgical samples
from spinal cord injured
patients with full
thickness PrU
Descriptive study
of 17 long-term
care patients with
stage III/IV ulcers
17 ulcers: 7 sacrum, 7
trochanter, 3 ischial
Intervention(s)
Outcome Measures &
Length of Follow-up
Compared effect of honey dressing
vs. ethoxy-diaminoacridine plus
nitrofurazone dressing on the
healing of stage II or III PrU using
PUSH scores
Results
Tissue specimens at the end of surgical
intervention were taken and used to
target antibiotic treatment
Used semi-quantitative method,
antibiotic susceptibility using agar
disc diffusion method
Culturing PrU
from surgically cleansed
sites allows for isolation of
bacteria species &
antibiotic susceptibility
Collect & analyze skin debris found on
peri-wound skin of patients with PrU &
to evaluate effect of peri-wound
cleansing on micro flora on peri-wound
& wound bed
Skin debris collected: wound bed,
1 cm (peri-wound) and 10 cm
(normal skin) from wound before
cleansing, protein largest quantity
of skin debris (keratinized cells),
counts increased with the amount
of protein
Per wound cleansing
caused a decrease in
wound/peri-wound
microbial counts so
authors suggest periwound cleansing daily
Good
Also in Table 9 - dressings
Heym B, Rimareix F, LortatJacob A, Nicolas-Chanoine
MH. Bacteriological
investigation of infected
pressure ulcers in spinal cordinjured patients and impact
on antibiotic therapy. Spinal
Cord. 2004;42(4):230-4.
Limitations
Study not blinded,
limited to stage II-III,
variability in potency of
antimicrobial effects
with unprocessed
honey, not clear if
cleanser ethoxydiaminoacridine alone
could have affected
results
Aggressive cleansing &
debridement of ulcer
during OR might have
effected results
Fair
Konya C, Sanada H, Sugama J,
Kitayama Y, Ishikawa S,
Togashi H, et al. Skin debris
and micro-organisms on the
peri-wound skin of pressure
ulcers and the influence of
peri-wound cleansing on
microbial flora. Ostomy
Wound Manage.
2005;51(1):50-9.
Good
Also in Table 7 - Cleansing
117
Sample size small, also
location of ulcer (area of
contamination) may
affect microbial load,
elderly pop only, its
effect on healing was
not studied
Treatment Technical Report
Indirect Evidence
Reference
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Evaluate the accuracy of
quantitative swabs
Results
Limitations
Bill TJ, Ratliff CR, Donovan
AM, Knox LK, Morgan RF,
Rodeheaver GT. Quantitative
swab culture versus tissue
biopsy: a comparison in
chronic wounds. Ostomy
Wound Manage.
2001;47(1):34-7.
Prospective,
nonrandomized
38 patients with chronic
wounds
Compared quantitative tissue biopsy
with quantitative swab in chronic
wounds
79% (28 of 38) of cultures,
both showed >105
18 PrU wounds
2004 Delphi
Survey to id
clinical signs of
wound infection in
6 wound types
54 members of which 810 on each wound panel
Panel asked to list clinical indicators of
infection, then scored list from 1st
round as to importance, rescored with
eliminating lower scores
Clinical indicators of infection and
rank them according to
importance: cellulitis, odor, pain,
delayed healing, wound
breakdown common to all
Pressure ulcers: cellulitis
high mean score, changes
in pain, crepitus, increase
in exudate, pus, serous
exudate with
inflammation, viable tissue
becoming slough, periwound warmth, wound
stops healing all had
medium mean score
Definitions that were
used may not be clear,
relevance may not be
related to infection i.e.
poor nutrition could
cause delayed healing
Prospective,
nonrandom
70 patients with clinically
non infected venous
ulcers
Whether there is a relationship
between wound microflora and
healing, usefulness of biopsies vs.
swabs
66 patients followed monthly for 6
months, 20 healed but 6 recurred
within 6 months, 4 lost to followup
Microbial load by swab
was predictive of
nonhealing & data from
biopsy does not enhance
the data
Looked at Venous ulcers
and no pressure ulcers
Development and
reliability testing
of clinical signs
and symptoms
31 patients from 4 sites
including acute care,
outpatient, long-term
care
Development and testing CSSC tool to
assess chronic wounds for 12 signs of
clinical localized infection
Standardize assessment-2
independent assessments for 31
patients using CSSC, percent
agreement & Kappa
16 PrU patients(52%), all
items had acceptable
reliability estimates. Heat,
odor, & discoloration of
Nurses need training
and this training may
have contributed to
high level of agreement
Good
Cutting KF, White RJ,
Mahoney P, Harding KG.
Clinical identification of
wound infection: a Delphi
approach in European Wound
Management. Identifying
criteria for wound infection
EWMA Position Document.
London2005. p. 6-9.
Strong- beginning to correlate
clinical features with micro
lab results
Davies CE, Hill KE, Newcombe
RG, Stephens P, Wilson MJ,
Harding KG, et al. A
prospective study of the
microbiology of chronic
venous leg ulcers to
reevaluate the clinical
predictive value of tissue
biopsies and swabs. Wound
Repair Regen. 2007;15(1):1722.
Strong
Gardner SE, Frantz RA, Troia
C, Eastman S, MacDonald M,
Buresh K, et al. A tool to
assess clinical signs and
118
Treatment Technical Report
Reference
Type of Study
symptoms of localized
infection in chronic wounds:
development and reliability.
Ostomy Wound Manage.
2001;47(1):40-7.
checklist for local
chronic wound
infection
Strong
Gardner SE, Frantz RA,
Saltzman CL, Dodgson KJ.
Staphylococcus aureus is
associated with high
microbial load in chronic
wounds. Wounds.
2004;16(8):251-7.
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Observational
cross-sectional
Nonarterial full thickness,
chronic wound patients,
66 wounds in the study
Identify the relationship between: S.
aureus and clinical signs of infection,
microbial load, number of different
species in the wound
Did not do serial micro analysis of
wounds over time, 51 of 66
wounds-diabetic
Observational
cross-sectional
44 Adults with chronic
wounds: 15 >106 29 <106
Exam accuracy of semi, quant,
compared to tissue biopsy using
Levine’s tech
Used 10 6 as definition of infection
Observational
cross-sectional
64 diabetic foot ulcer
patients
Exam reliability of revised CSS Checklist
in sample of diabetic foot ulcer
patients
Observational,
cross-sectional
Adults with chronic full
thickness wounds (except
no arterial wounds)-83
wounds with 6 PrU
Exam diagnostic validity of 3 swab
techniques ( Z, Levine, biopsy) in
identifying chronic wound infection
2 nurses used checklist on 64
patients. Reliability of each item
calculated using percent
agreement & Kappa coefficient,
Items: pain, erythema, edema,
heat, purulent exudate,
sanguineous drainage, delayed
healing, discolored, friable
granulation, pockets, odor,
breakdown
Used 106 as definition of infection,
other parameters-number of
different organisms, pathology of
organisms
Strong
Gardner SE, Frantz RA,
Saltzman CL, Hillis SL, Park H,
Scherubel M. Diagnostic
validity of three swab
Limitations
gran tissue had moderate
agreement while pain,
edema, wound
breakdown, delayed
healing, & friable gran
almost perfect agreement
Strong
Gardner SE, Frantz R, Hillis SL,
Park H, Scherubel M.
Diagnostic validity of semi
quantitative swab cultures.
Wounds. 2007;19(2):31-8.
Strong but only had 2 PrU
wounds which were not
infected
Gardner SE, Frantz RA, Park
H, Scherubel M. The interrater reliability of the Clinical
Signs and Symptoms Checklist
in diabetic foot ulcers.
Ostomy Wound Manage.
2007;53(1):46-51.
Results
119
S. aureus isolated from 34
(52%) of wounds but
predominate organism in
only 29%. No statistically
significant difference
between SA & non-SA
whether they appeared
clinically infected, SA
wounds significantly more
likely to contain >105 than
non-SA wounds, mean # of
species from each wound2.7, 12(18%)- appeared
clinically infected,
24(36%)->105 positive
biopsies
Semi-quant swabs do not
correlate with tissue
specimens
5 PrU wounds: 3 with SA
& 2 non-SA. Technique
for isolation of
anaerobes- used only 48
hour incubation
Total percent agreement
ranged from 76-100% and
kappa ranged from .34 to
1.0 showing it is a reliable
tool for identifying signs of
localized infection
All diabetic plantar
ulcers. Most dressed
with gauze, nurses were
trained in chronic
wounds
Swab using Levine’s
performed better than
wound exudate or Z tech
Only used 6 PrU wounds
and all 6 were not
infected.
Only had 2 PrU patients
and they were not
infected
Treatment Technical Report
Reference
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Results
Limitations
Cross-sectional
design
PCW assessed for 12
signs of infection, 36
enrolled
Validity of signs used to identify
chronic wound infection i.e. sensitivity
and specificity of list compared to
tissue biopsy,
Secondary signs expressed more
frequently than classic signs,
however no one sign achieved
100% sensitivity
Patients receiving systemic
antibiotics were less likely
to have infected wounds,
validity of signs was
supported with exception
of pocketing of wound
base
19 PrU with 3 being
infected and 16 being
noninfected, limited
generalizability
Nonexperimental,
descriptive
10 chronic wounds
Evaluated 10 chronic wounds for
comparison of Brentano wet culturing
tech with quant biopsy
Wilcoxon matched pair test
indicated groups not equal & tissue
cultures had significantly larger
number of cfu, Pearson’s
correlation showed swab counts
didn’t predict tissue counts
Wet culture correctly
indicated infection 80% of
the time
Debrided wounds prior
to culturing, small
sample, only aerobic
cultures, only 1 PrU
Prospective,
nonrandomized
124 wounds swabbed
Compare quantitative swabs with
semi-quantitative swabs in chronic
wounds
Linear regression demonstrated a
statistically significant correlation
between the 2 tech with
coefficient of r = 0.84 with p <
0.001
53/124 quant swabs >105,
42 semi-quant on same
wounds had growth on
quad III/IV for sensitivity of
79%
44 PrU wounds
Outcome Measures &
Length of Follow-up
9 experimental studies- no
evidence of negative impact of
tissue regeneration with PVP-I, 6
Results
Limitations
Effect size of 1 (i.e. n=1),
small (n< 50), medium
(n<400), large (n>400).
Many assumptions
made, article
availability. Bias with
techniques for identifying
chronic wound infection.
Wound Repair Regen.
2006;14(5):548-57.
Strong study but only 6 PrU
wounds which were not
infected
Gardner SE, Frantz RA,
Doebbeling BN. The validity
of the clinical signs and
symptoms used to identify
localized chronic wound
infection. Wound Repair
Regen. 2001;9(3):178-86.
Strong
Neil JA, Munro CL. A
comparison of two culturing
methods for chronic
wounds... including
commentary by van Rijswijk L,
Stotts NA, and Soeken KL.
Ostomy Wound Manage.
1997;43(3):20.
Fair-small sample
Ratliff CR, Rodeheaver GT.
Correlation of semiquantitative swab cultures to
quantitative swab cultures
from chronic wounds.
Wounds. 2002;14(9):329-33.
Good
Indirect Evidence (Topical Agents for Infection)
Reference
Type of Study
Sample
Intervention(s)
Banwell H. What is the
evidence for tissue
regeneration impairment
Search of 6
databases
41 articles
Range of literature available on PVP-I
use & evidence supporting its use &
effect on tissue impairment
120
Treatment Technical Report
Reference
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
articles refuted this, one
inconclusive, also looked at articles
with descript studies, expert
opinion
when using a formulation of
PVP-I antiseptic on open
wounds? Dermatology.
2006;212 Suppl 1:66-76.
Results
Limitations
Much debate over use
especially 10% in
soln/ointment
using reader scoring
tool
Good
Bergin SM, Wraight P. Silver
based wound dressings and
topical agents for treating
diabetic foot ulcers. Cochrane
Database Syst Rev. 2007(2).
Randomized trials
& nonrandomized
Diabetics with foot ulcers
To evaluate effects of silver
dressings/topical agents on infection
rates & healing of diabetic foot ulcers
Despite widespread use,
no randomized control
trials or controlled trials
exist that evaluate their
effectiveness
Randomized and
pseudorandomized
(alternate
allocation)
Search trials from
Cochrane Wounds
Group, Cochrane
controlled trials
To evaluate the effectiveness of
dressings used in the treatment of
pressure sores
Time to complete healing or rate of
healing
This is a protocol
Questionnaire
including
observational
about infection
status of wound
20 RNs in pairs over 10
weeks viewed 4 wounds
for total of 40 wounds
Insight into criteria used to identify
infection compared RNS with author
RNs not always able to accurately
identify infection in granulating
wounds, author’s accuracy-39 out
of 40 decisions (97.5%)
Varying levels of RN
wound education
No burns/leg ulcers
looked at wounds
healing by 2ndary
intention, RNS of
varying experience,
unknown if PrU
included
Retrospective data
base from general
practice databases
455 patients with chronic
wounds were identified
(PCW)
Quantity and pattern of antibiotic
prescribing for patients with chronic
wounds in the UK
N/A
over 2/3 of PCWs received
at least 1 course of
systemic antibiotics
compared with 1/3 of nonwound patients, diabetes
had no significant impact,
leg ulcers & venous ulcer
most common
68 patients with PrU,
retrospective chart
review
RCTs and CCTs
Searched 16 databases
Review the evidence for antimicrobial
Evidence is too weak
23 studies
Trials too small and
Strong
Bradley M, Nelson EA,
Pettigrew M, Cullum N,
Sheldon T. Dressings for
pressure sores. Cochrane
Database Syst Rev.
1998;3:CD001179.
Strong
Cutting KF. Identification of
infection in granulating
wounds by registered nurses.
J Clin Nurs. 1998;7(6):539-46.
Fair
Training is key to
identification of subtle signs
of infection
Howell-Jones RS, Price PE,
Howard AJ, Thomas DW.
Antibiotic prescribing for
chronic skin wounds in
primary care. Wound Repair
Regen. 2006;14(4):387-93.
Good- need to look at
antibiotic prescribing
practices –role, duration, role
in resistance
Nelson EA, O'Meara S, Golder
121
Treatment Technical Report
Reference
Type of Study
Sample
S, Dalton J, Craig D, Iglesias C.
Systematic review of
antimicrobial treatments for
diabetic foot ulcers. Diabet
Med. 2006;23(4):348-59.
Intervention(s)
Outcome Measures &
Length of Follow-up
Results
intervention for diabetic foot ulcers
Limitations
dissimilar
Strong
Jull AB, Rodgers A, Walker N.
Honey as a topical treatment
for wounds. Cochrane
Database Syst Rev.
2004;2:CD005083.
Strong
O'Meara S, Cullum N, Majid
M, Sheldon T. Systematic
reviews of wound care
management: (3)
antimicrobial agents for
chronic wounds; (4) diabetic
foot ulceration. Health
Technol Assess. 2000;4(21):1237.
Strong
O’Meara S, Cullum N, Majid
M, Sheldon T. Executive
Summary: Systematic reviews
of wound care management:
(3) antimicrobial agents for
chronic wounds; (4) diabetic
foot ulceration. Health
Technol Assess. 2000;4(21).
Strong
O'Meara S, Nelson EA, Golder
S, Dalton JE, Craig D, Iglesias
C. Systematic review of
methods to diagnose
infection in foot ulcers in
diabetes. Diabet Med.
Randomized and
pseudorandomized
(alternate
allocation)
Search trials from
Cochrane Wounds
Group, Cochrane
controlled trials, AMED,
LILACS, experts
To assess whether use of honey has
any benefit in wound healing:
increases the rate of healing in acute &
chronic wounds
Time to complete healing,
proportion of wounds healed
This is a protocol
30 studies, 25
with random, 9
evaluations of
systemic agents
and 21 topical
agents
18 databases Relevant
journals, confer, & bibs
were hand searched
Any systemic or topical agents with
antimicrobial prop including
antibiotics, anti-fungal preps, anti-viral
and alternative approaches
Primary outcome was wound
healing such as change in ulcer
size, rate of healing, frequency of
complete healing or time to heal.
Studies reporting solely micro
outcomes were excluded
PRU- no systemic trials,
several topical agents may
be helpful in general for
chronic wounds but
further research for
effectiveness so cost
minimization may be used
to guide decisions
Methodological
problems with most
common being sample
size
Random &
nonrandom trials
with concurrent
control group
which evaluate
intervention for
prevention or
treatment of
diabetic ulcers or
topical
antimicrobial for
chronic wounds
(including PrU)
RCTs and CCTs
19 databases including
Medline, CINAHL,
Embase & Cochrane.
Relevant journals, confer,
& bibs were hand
searched
Diabetic-39 trials
Antimicrobials- 30 with 25 of
randomized design. 9 evaluations of
systemic antibiotics, 21 of topical
agents
Antimicrobials-PrU: no evidence in
favor of topical antimicrobials for
PrU prevention, oxyquinolone
ointment significantly more
effective than standard emollient
for treatment of PrU in 1 study, no
significant difference between
hydrocolloid and povidone iodine
ointment or between gentian
violet and povidone iodine/sugar
ointment
most have insufficient
statistical power to detect
true treatment effect
Methodological quality
poor
19 databases plus other
sources
Systematic review of diagnostic
performance of clinical exam, sample
analysis in infected diabetic foot ulcers
Inconclusive because of sample
size
3 studies
Too small and too few
122
Treatment Technical Report
Reference
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Results
Limitations
In-vitro
experimental
7 dressings:
Aquacel Ag,
Acticoat, Silvercel,
Contreet foam, polymem
silver, urogotul, silvasorb
Compared in-vitro antibacterial activity
of 7 silver dressings against S. aureus
and P. aeruginosa-silver release and/or
silver content
Repeat challenge assays over 7
days for each dressing and a
control dressing
Silver content not found to
be predictor of
antibacterial activity so
choice of dressing should
not be based on this alone
Technique used
measured total
amount of silver in
solution and cannot
differ. between active
and inactive forms
Randomized and
pseudorandomized
(alternate
allocation),
published and
unpublished
Search trials from
Cochrane Wounds
Group, Cochrane
controlled trials
To evaluate the effectiveness of
dressings and topical agents containing
silver to prevent wound infection of
wounds of any etiology in any care
setting
Studies must report objective
measure of established wound
infection rate, objective measure
of wound healing rate, days of
wound infection
This is a protocol
Systematic review
3 RCTS for 847
participants
1 trial compared silver-containing
foam(Contreet®) with hydrocellular
foam (Allevyn®) in leg ulcer patients. 2
trial compared silver-containing
alginate(Silvercel®) with alginate
(Algosteril®) in leg and pressure ulcers
3 trial compared a foam dressing
(Contreet®) with best care for chronic
wounds
4 weeks of follow-up
Insufficient evidence to
recommend use of silvercontaining dressings or
topical agents for
treatment of infected or
contaminated chronic
wounds,
Greater reduction in ulcer
size was observed with
silver-containing foam but
no significant difference in
rates of complete healing
after 4 weeks
2006;23(4):341-7.
Strong
Parsons D, Bowler PG, Myles
V, Jones S. Silver
antimicrobial dressings in
wound management: a
comparison of antibacterial,
physical, and chemical
characteristics. Wounds.
2005;17(8):222-32.
Good
Ubbink DT, Vermeulen H,
Storm-Versloot MN. Topical
silver for preventing infected
wounds. (Protocol). Cochrane
Database Syst Rev. 2007;ID:
CD006478(2) DOI:
10.1002/14651858.CD006478
).
Strong
Vermeulen H, van Hattem JM,
Storm-Versloot MN, Ubbink
DT. Topical silver for treating
infected wounds. Cochrane
Database Syst Rev.
2007(1):CD005486.
Strong
123
Only 3 trials with short
duration of follow-up,
small numbers and of
low power, duration of
wound infection not
mentioned
Treatment Technical Report
Table 10. Biophysical Agents
Electromagnetic Spectrum
Reference
Type of Study
Sample
Intervention(s)
Adegoke BO, Badmos KA.
Acceleration of pressure ulcer
healing in spinal cord injured
patients using interrupted
direct current. Afr J Med Med
Sci. 2001;30(3):195-7.
RCT
6 SCI with Pressure
Ulcers
RCT
N= 185 controls N ?
SCI with PrU
Pressure ulcers
N=8
Indirect evidence, less than
10 subjects
Baker LL, Rubayi S, Villar F,
DeMuth SK. Effect of
electrical stimulation
waveform on healing of
ulcers in human beings with
spinal cord injury. Wound
Repair Regen. 1996;4(1):21-8.
Edsberg LE, Brogan MS,
Jaynes CD, Fries K. Topical
hyperbaric oxygen and
electrical stimulation:
exploring potential synergy.
Ostomy Wound Manage.
2002;48(11):42.
Results
Limitations
Interrupted DC
Outcome Measures &
Length of Follow-up
Pressure ulcer size
IDC group: 22% decrease
in size; nursing group :
2.6% decrease in size
Small sample. One
patient dropped out
of study. Supports
work of prior studies
that ES is effective in
reducing pressure
ulcer size
Asymetric Biphasic
Wound healing
Wound healing rates
increased by 60% over
controls
Enhanced wound closure with
topical HBO and topical HBO &
electrical stimulation
No significant difference
between topical HBO
alone and topical HBO
with electrical stimulation
Larger, controlled
study to determine
efficacy needed
Recommendation
based on data from all
chronic wound types
Results of both trials
suggestive of a benefit
associated with
electromagnetic
therapy
Prospective,
uncontrolled
Also see hyperbaric oxygen
Flemming K, Cullum N.
Electromagnetic therapy for
the treatment of pressure
sores. Cochrane Database
System Rev(Online).
2001(1):CD002930
Systematic Review
N = 10 Stage II; N=10
stage III
Induced ES ( PRFS)
Pressure ulcer healing
Stage II: Median no of
days to healing 13.0;active
group 84% healed at 1
week; sham 40% healed in
1 week ; Median no of
days to healing 31.5; Stage
III active decreased area
5.9% /week; sham 1.7%
/week
Meta-analysis
15 studies
Mixed types of electrical stimulation
Pressure ulcer healing
Electrical stimulation was
most effective on pressure
ulcers (net effect = 13%).
Systematic Review
Gardner SE, Frantz RA,
Schmidt FL. Effect of electrical
stimulation on chronic wound
Meta-analysis
124
Treatment Technical Report
Reference
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
healing: a meta-analysis.
Wound Repair Regen.
1999;7(6):495-503.
Stefanovska A, Vodovnik L,
Benko H, Turk R. Treatment
of chronic wounds by means
of electric and
electromagnetic fields. Part 2.
Value of FES parameters for
pressure sore treatment.
Med Biol Eng Comput.
1993;31(3):213-20.
RCT
N=185
Biphasic electrical stimulation
Pressure ulcer healing
Results
Limitations
Electrical stimulation
produces a substantial
improvement in the
healing of chronic wounds,
further research is needed
to identify which electrical
stimulation devices are
most effective and which
wounds respond best to
this treatment
Healing rate improved by
60% compared to controls
Pressure ulcers , SCI
Phototherapy (Laser, Infrared (with and without warming, Ultraviolet)
Reference
Type of Study
Sample
Intervention(s)
Dehlin O, Elmståhl S, Gottrup
F. Monochromatic
phototherapy: effective
treatment for grade II chronic
pressure ulcers in elderly
patients. Aging Clin Exp Res.
2007;19(6):478-83.
Pressure ulcers
RCT
N = 164
Monochromatic photo therapy
Nussbaum EL, Biemann I,
Mustard B. Comparison of
ultrasound/ultraviolet-C and
laser for treatment of
pressure ulcers in patients
with spinal cord injury. Phys
Ther. 1994;74(9):812-23.
Small RCT
a control group
(n = 9), a US/UVC group
(n = 5), and a laser group
(n=6).
20 patients
Spinal cord unit/hospital
Also see acoustic energy
125
Outcome Measures &
Length of Follow-up
Time to healing calculated using
survival analysis
Results
Limitations
No significant effects
overall; sub-analysis
tendency toward
enhanced healing;
significantly larger
reduction in pressure
ulcers among patients with
low BMI
May be beneficial to
healing in individuals
with low BMI
Combined therapy of ultrasound
and UVC with standardized wound
care for individuals with pressure
ulcers resulted in faster healing
times than standardized wound
care combined with laser.
Results showed that
USIWC treatment had a
greater effect on wound
healing than did nursing
care, either alone or
combined with laser.
Difficult to draw
conclusion as 2
treatment types
combined and
compared against
laser
Ultrasound-ultraviolet-C
may decrease healing time
However, U/S has
been shown to
Treatment Technical Report
Reference
Schubert V. Effects of
phototherapy on pressure
ulcer healing in elderly
patients after a falling
trauma. A prospective,
randomized, controlled study.
Photodermatol
Photoimmunol Photomed.
2001;17(1):32-8.
Thai TP, Keast DH, Campbell
KE, Woodbury MG, Houghton
PE. Effect of ultraviolet light C
on bacterial colonization in
chronic wounds. Ostomy
Wound Manage.
2005;51(10):32-45.
Type of Study
Pressure ulcers
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
N = 74
Results
Limitations
and may allow faster
return to rehabilitation
program, work, and leisure
activities for patients with
spinal cord injury who
have pressure ulcers.
enhance healing in a
number of studies (10)
in chronic wounds and
UVC has been shown
to enhance healing
and decrease bacterial
levels in a small
number of studies
with a small number
of participants
Homogenous group by
age
Normalized ulcer area vs. time;
Time-averaged healing rate
Significantly faster healing
rates in treatment group
Results of this study also suggest
that a single 180-second treatment
of UVC was able to kill bacteria,
including antibiotic-resistant
bacteria such as MRSA, present in
all types of chronic superficial
wounds, including pressure,
diabetic, venous, and arterial
ulcers. However, findings from this
study suggest that the response to
UVC may be dependent on the
type and relative amount of
bacteria present initially in the
wound bed.
A statistically significant
reduction of predominant
bacteria was noted
following a single UVC
treatment (P <0.0001, n =
22) (see Figure 3).
Furthermore, significant
reductions of MRSA (P
<0.05), S. aureus (P <0.01),
and other types of bacteria
(combination of P.
Pseudomonas aeruginosa
and Streptococcus group B
and G, (P <0.05) were
noted.
Prospective RCT
Pre-test, post-test
UVC treatment
study
22 individuals with
chronic wounds including
pressure ulcers (n = 7)
Baseline control comparison
equal number of men
and women
elderly subjects
126
Did not meet the
criteria for inclusion (7
subject clinical study)
Treatment Technical Report
Acoustic Energy (Ultrasound)
Reference
Type of Study
Sample
Intervention(s)
Ellis SL, Finn P, Noone M,
Leaper DJ. Eradication of
methicillin-resistant
Staphylococcus aureus from
pressure sores using warming
therapy. Surg Infect.
2003;4(1):53-5.
RCT
N =33; 23 completed 4
weeks; 16 completed 8
weeks of study
Warming Therapy
Ennis WJ, Valdes W, Gainer
M, Meneses P. Evaluation of
clinical effectiveness of MIST
ultrasound therapy for the
healing of chronic wounds.
Adv Skin Wound Care.
2006;19(8):437-46.
Prospective Noncomparative
clinical outcomes
trial
N=23 with 29 wounds;
Historic controls N=122
Low FQ MIST (40kz) followed by
Moisture retentive dressing; Length of
treatment time varied depending on
size of ulcer from 3x/week;
debridement PRN ; MIST assisted
therapy ( MIST treatment followed by
a subsequent treatment ( e.g. ES or
MHZ US)
Ennis WJ, Foremann P, Mozen
N, Massey J, Conner-Kerr T,
Meneses P. Ultrasound
therapy for recalcitrant
diabetic foot ulcers: results of
a randomized, double-blind,
controlled, multicenter study.
Ostomy Wound Manage.
2005;51(8):24-39.
Mixed chronic (> 4
weeks)
recalcitrant
wounds of lower
extremity;
matched for
demographics of
size and ulcer
duration; by % of
number in each
group with
comorbidities
listed. Only 1
patient with PrU
in current study;
46 in historic
study ; Mean
value for baseline
TCPO2 = 30%;
Prospective DB
RCT
Outcome Measures &
Length of Follow-up
Bacterial cultures; semiquantitative swabs
Results
Limitations
Reduction of MRSA in IRtreated group; no
difference in healing rates
Small sample size; large
number of withdrawals
and drop outs
Mixture of ES, MHz US, or
combination of the 2
Current study: overall
Healed Mist Only 31%
(N=9). Mist Assisted
37.9% (N=11).
Not Healed: 20.7% (N=6)
Historic study: Over all
healing with PrU: 64.7 %
(N=33/157) ( this does not
match the number of
historic controls; not
explained)
No conclusion can be
Reached specific to PrU
healing. MIST appears
to improve healing of
chronic wounds. Trend
is that this can be
applied to PrU as well
as other chronic
wounds with expected
good outcomes.
Validated measurements
and statistical methods
were used
Treatment=27
Control=28
Low FQ MIST ( 40 khz) + SWC 4
minutes 3x/week for 12 weeks or until
closed
Diabetic Foot
Ulcers
127
SWC
MIST group had a 40.7%
closure rate vs. 14.3%
closure for controls;
diminished exudate in
treatment group not in
controls
Well- designed study.
Shows improved
healing with low fq US
Not a PrU study but
trend supports
improved healing with
Lo FQ US for chronic
diabetic ulcers
Treatment Technical Report
Reference
Type of Study
Sample
Intervention(s)
Johannsen F, Gam AN,
Karlsmark T. Ultrasound
therapy in chronic leg
ulceration: a meta-analysis.
Wound Repair Regen.
1998;6(2):121-6.
RCT
6 studies
1MHz, 3Mhz and 30khz; different
intensities used; time 5-10 min
3x/week. 3 delivered peri-wound 3, 1
surface, 1 both.
Kavros SJ, Miller JL, Hanna
SW. Treatment of ischemic
wounds with noncontact,
low-frequency ultrasound:
the Mayo clinic experience,
2004-2006. Adv Skin Wound
Care. 2007;20(4):221-6.
Prospective ,
parallel group RCT
Non-healing leg
and foot ulcers
associated with
chronic critical
limb ischemia
MIST N=35; controls
N=35
Low FQ MIST (40Khz) + SWC ; 3x/week
x 12 weeks
Nussbaum EL, Biemann I,
Mustard B.Comparison of
ultrasound/ultraviolet-C and
laser for treatment of
pressure ulcers in patients
with spinal cord injury. Phys
Ther. 1994;74(9):812-23.
Small RCT
a control group
(n = 9), a US/UVC group
(n = 5), and a laser group
(n=6).
6 studies of US
effect of healing
on chronic leg
ulcers
20 patients
Outcome Measures &
Length of Follow-up
Not reported
Results
Limitations
Greater % of ulcers treated
with US healed compared
to controls
Significant effect of US
on venous ulcers
demonstrated. Best
response noted from
low FQ 30kHz
Standard Wound Care (SWC)
63% of MIST group
achieved >50% healing in
12 weeks vs. controls 29%
( P<.001) ; measurement
technique subject to
human error; TcPO2
<20mm Hg at baseline
healed <50% during trial
Combined therapy of ultrasound
and UVC with standardized wound
care for individuals with pressure
ulcers resulted in faster healing
times than standardized wound
care combined with laser.
Results showed that
USIWC treatment had a
greater effect on wound
healing than did nursing
care, either alone or
combined with laser.
Addition of MIST
statistically improved
healing of chronic
ischemic leg ulcers.
Study well designed ;
application to PrU
healing is probable not
proven
Also not proven: effect
on wound pain or
bacterial burden
Difficult to draw
conclusion as 2
treatment types
combined and
compared against laser
Spinal cord unit/hospital
Ultrasound-ultraviolet-C
may decrease healing time
and may allow faster
return to rehabilitation
program, work, and leisure
activities for patients with
spinal cord injury who
have pressure ulcers.
Also see phototherapy
ter Riet G, Kessels AG,
Knipschild P. A randomized
clinical trial of ultrasound in
the treatment of pressure
ulcers. Phys Ther.
1996;76(12):1301-11.
RCT
Pressure ulcers:
16 Stage IV
72 lesser stage II
& III;
Stage II ulcers had
Treatment=45
Control=43
Sham US;
Cleansing: NS or chlorhexidine 0.1%
3.28 MHz ; SATA intensity 0.1 W/cm2 ;
treatment to wound edge and wound
bed (cover with Tegaderm and fill
volume with NS to transmit US)
Cleansing: NS or chlorhexidine 0.1%
128
Wound healing (rate & closure)
Measurements: closure
rates: 0.18 mc2 / week for
US group; 0.31 cm2 /week
sham.
Points based on subjective
evaluation: US .71
points/week; sham .46
points/week
However, U/S has been
shown to enhance
healing in a number of
studies (10) in chronic
wounds and UVC has
been shown to enhance
healing and decrease
bacterial levels in a
small number of studies
with a small number of
participants
Study limitations: PrU
studied included ulcers
of mixed stages
Unspecified number
also received antibiotic
(ATB) therapy for
infection.
Many patients were
critically ill in both
groups resulting in 15
Treatment Technical Report
Reference
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Results
not healed in prior
7 days
All ulcers located
on trunk.
Whitney JD, Salvadalena G,
Higa L, Mich M. Treatment of
pressure ulcers with
noncontact normothermic
wound therapy: healing and
warming effects. J Wound
Ostomy Continence Nurs.
2001;28(5):244-52.
Pressure ulcers
N = 40; 29 completed
study
Limitations
deaths from nontreatment related
causes.
Conclusion: cannot
demonstrate significant
beneficial effects for
infected or clean PrU
but treatment group
showed some better
clinical outcomes
Comment: due to
mixed stages, critically
ill elderly patients and
use of ATB and
Chlorhexidine for some
patients, this study has
significant flaws.
Small sample size
PSST
Significantly faster rates of
healing with IR-modality
Outcome Measures &
Length of Follow-up
Subjects seen at 3 & 6 weeks,
3 weeks:
Photograph, plaster wound
impression and measurements
Results
Limitations
22 patients with 35 ulcers
completed the trial. 3
patients lost to follow-up,
1 noncompliant, 2 patients
died
Exclusion criteria were
extensive, sample was
unlike most PrU patients
Prospective, RCT
Negative Pressure Wound Therapy
Reference
Type of Study
Sample
Intervention(s)
Ford CN, Reinhard ER, Yeh D,
Syrek D, De Las Morenas A,
Bergman SB, et al. Interim
analysis of a prospective,
randomized trial of vacuumassisted closure versus the
healthpoint system in the
management of pressure
ulcers. Ann Plast Surg.
2002;49(1):55.
Prospective
randomized trial
6 weeks duration
28 patients with 41 full
thickness PrU present
for 4 weeks were
recruited to randomized
to NPWT to an
antimicrobial
(Cadexomer iodine (CXId)
with amorphous or
sheets) for wounds with
exudate or Panafil for
clean ulcers
Prior to the study, subjects had CBC,
ESR, albumin, photograph, soft tissue
biopsy, plaster wound impression,
wound size, bone biopsy and culture
and MRI to rule out osteomyelitis if
needed. If osteomyelitis present had 6
weeks of antibiotics
Clinic staff blinded
to study group
3 patients with 3
wounds crossed
over to other
treatment
All wounds were débrided surgically if
needed, no other debridement was
done
6 week: photograph, soft tissue
biopsy, plaster wound impression,
and measurements
Also had bone biopsy and MRI if
done prior
Follow-up ranged 3-10 months
129
Age of sample:
NPWT mean age 41.7
years Cadexomer mean
age 54.4 years
Ulcer distribution:
Ischial = 9
Study was of all wounds
not of subjects
Subject burden was
extensive
Ulcer infection is a major
healing deterrent and
Treatment Technical Report
Reference
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Inclusion criteria:
Albumin2.0, age 21-80,
ulcer volume 10-150 ml
measured by plastic
wound impression
NPWT dressings changed MWF
(manufacture recommends every 48
hours), Iodosorb dressings changed
once or twice daily (manufactured
recommends twice weekly dressing
changes)
Exclusion criteria
Fistula, cancer,
pregnancy. lactation,
Graves’ disease, iodine
allergy, burns, sepsis,
uncontrolled DM,
orthopedic hardware,
renal or pulmonary
disease, use of steroids
Results
Limitations
Sacral = 17
Lateral malleolar = 4
Trochanteric = 1
Heel =4
this study did not
distinguish which ulcers
received iodine or
Panafil. The PMNs
decreased in NPWT
group, but this could also
be due to management
of systemic infections
beyond wound
infections.
2 ulcers in each group
healed completely ; 1
patient needed
amputation
6 of the NPWT and 6 of
CXId/Panafil group had
flap surgery
Mean reduction in wound
volume
NPWT = 51.8%
CXid = 42.1%
(p = 0.046)
Mean reduction in length
NPWT = 36.9 cm
CXid = 18.7 cm
(p = 0.10)
Mean reduction in width
NPWT = 40.0 cm
CXid = 19.0 cm
(p =0.11)
Mean reduction in depth
NPWT = 33.6 cm
CXid = 31.0 cm
(p = 0.90)
15/35 wounds were
suspicious for
osteomyelitis and 3
positive by biopsy and 10
positive by MRI imaging
PMN count
NWPT = -37.0
CXId = +22.7
(p = 0.13)
Lymphocytes
NPWT = -6.2
CXId = +45.0
(p = 0.41)
130
There were actually 3
groups in this study, but
the Panafil and CXId
groups were reported as
1 group
This study had excellent
measures of healing, but
violated some basic
principles of research.
Treatment Technical Report
Reference
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Results
Limitations
No difference in capillary
numbers in either group
Joseph E, Hamori CA,
Bergman S, Roaf E, Swann NF,
Anastasi GW. New
therapeutic approaches in
wound care. A prospective
randomized trial of vacuumassisted closure versus
standard therapy of chronic
nonhealing wounds. Wounds.
2000;12(3):60-7.
Prospective
randomized trial
comparing NPWT
to wet to moist
gauze dressings
covered with a
thin film to
simulate closed
therapy without
suction
24 patients with chronic
wounds (N = 28/ 36
wounds were PrU or
79%)
12 men and 12 women
Inclusion Criteria
Wounds over 4 weeks
duration without signs of
healing or closure
Exclusion Criteria
Infection (UTI,
pneumonia, wound)
Albumin < 3.0
Uncontrolled DM, HPT,
thyroid, renal or lung
disease
Immunosuppressive
Pregnancy or breast
feedings
Osteomyelitis by bone
biopsy
Cancer, fistula (stomal or
rectal)
All débrided if needed 48 hours prior to
treatment
NPWT dressings changed every 48
hours
WMG changed 3 times per day and
kept continually moist with NS
All patients were given zinc, MVI and
nutrition
All placed on therapeutic sleep
surfaces
Likely to be cooperative
All patients were offered
surgical closure of any
remaining wounds
131
Wound measurements , photos,
alginate impressions, blood tests
and biopsy and culture of wounds
at 3 and 6 weeks
Measurement of
dressing , edema, erythema
exposed bone or tendon
3 wounds in NPWT
showed improved
osteomyelitis
CXId wounds (N not
stated) showed no
improvement in
osteomyelitis by biopsy or
MRI (p =0.25)
18 wounds were
randomized to treatment
group, each wound was
randomized. 3 patients
had wounds with both
therapies
Nice attempt to mimic
NWPT in this study
Were the NPWT the
same pump
21% (N =5) required acute
care (previous locale
unknown); 38% (N =9) in
LTC, 42% (N=10) home
care
Inflammation was
increased in WMG even
though no infection
present at start of
therapy
Group comparison
Age (p = ns)
NPWT mean 56
WMG mean 49
Gender (% Male) (p = ns)
NPWT 66%
WMG 44%
Wound depth (% change
in depth)
NPWT = 66%
WMG = 20%
(p 0.00001)
Wound length (% change
in length)
NS change (no detail
provided)
Wound width (% change in
width)
Actual numbers not
given
(p 0.02)
Study looked at ulcers
not patients; but did
randomize study groups
by wounds
2 patients had calcaneal
fractures due to DM and
ambulating while
wearing NPWT.
Eventually required
amputation for
osteomyelitis
Treatment Technical Report
Reference
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Results
Limitations
Initial wound volume
NPWT = 38 cc
WMG = 24 cc
Wound volume (% change
in volume)
NPWT = 78%
WMG = 30%
(p 0.038)
Histological differences in
groups
WMG = 81%
inflammation and fibrosis
NPWT = 64% granulation
tissue
Complications after RX
began
(infection/osteomyelitis,
fistula)
WMG = 44% (N=8)
NPWT = 17% (N =3)
( p 0.0028)
Philbeck TE, Jr., Whittington
KT, Millsap MH, Briones RB,
Wight DG, Schroeder WJ. The
clinical and cost effectiveness
of externally applied negative
pressure wound therapy in
the treatment of wounds in
home healthcare Medicare
patients. Ostomy Wound
Manage. 1999;45(11):41-50.
Wanner MB, Schwarzl F,
Strub B, Zaech GA, Pierer G.
Vacuum-assisted wound
closure for cheaper and more
comfortable healing of
Retrospective
record review (N
=1262) of KCI
records for
qualification for
therapy in
patients who had
failed prior
interventions.
Data were
complete on 1032
records which was
more than 17,000
data entries
Stage III PrU = 183
Stage IV = 383
Prospective RCT
22 SCI patients with
pelvic pressure ulcers
compared to dressings
with Ringer’s dressing
(wet to dry or wet to
Data taken from records
43 PrU were located on
trunk and trochanter
(stage III
and IV)
Wound age
Wound location
Prior dressings
Wound description
(color, dressing type odor and
amount)
Support surface
Reason for stopping NPWT
Wound healing rate computed
(cm2/day)
Wound volume (cm3/day)
Wound volume change (cm3/days)
All wounds (N =1170)
Sacrum = 198 (16.9%)
Ischia = 167 (14.3%)
Trochanter = 72 (6.2%)
Leg wounds not included
since etiology is mixed, but
is likely 58 (495 – 437 = 58)
495 patients with pressure
ulcers were placed on a
pressure reduction surface
(566 patients possible)
Healing rates were
compared to Ferrell’s
work (1984) (He found 84
patients with PrU healed
at 0.090 cm2 per day).
This study estimated that
using an average ulcer
size of 22.2 cm2, would
require 97 days to heal
using NPWT and
compares healing in
Ferrell’s work estimating
time to heal at 247 days.
PrU healing rate = 0.23
cm2 /day
Surgical debridement for all subjects,
treatment on day 2
Wet to dry dressings until granulation
tissue, then changed to wet to moist
132
Wound volume measured with NS
insertion into wound (reliability
confirmed)
End point = wound volume
Group comparison
Age p = NS
NPWT = 49 (25-73)
Dressing = 53 (34-77)
Gender
p = NS
Study compared absolute
initial wound volume
They questioned the
change in prior wound
volumes to be an
Treatment Technical Report
Reference
Type of Study
pressure sores: a prospective
study. Scand J Plast Reconstr
Surg Hand Surg.
2003;37(1):28-33.
Sample
Intervention(s)
wet)
and dressings kept moist
NWPT (continuous pressure of -125
mm HG) with dressings changed at 2-7
days
When wound volume
reduced by 50%, all
patients closed with flaps
Outcome Measures &
Length of Follow-up
reduced by 50%
Results
NPWT = 7 males
Dressings = 8 males
Initial mean wound
volume p = NS
NPWT = 50 (3-132)
Dressing = 42 (5-68)
All patients prone, on air fluidized bed
or air bed
Limitations
mechanical effect of
NPWT pulling on wound
edges
What was the effect of
the Ringer’s over Normal
saline used in most
wound care?
Mean days to 50%
reduction in wound
volume
NPWT = = 27 days (SD 10
days)
Dressing = 28 days (SD 7
days)
Granulation tissue
formation equal in both
groups
Oxygen Therapies
Reference
Type of Study
Sample
Edsberg LE, Brogan MS,
Jaynes CD, Fries K. Topical
hyperbaric oxygen and
electrical stimulation:
exploring potential synergy.
Ostomy Wound Manage.
2002;48(11):42.
Pressure ulcers
N=8
Intervention(s)
Outcome Measures &
Length of Follow-up
Enhanced wound closure with
topical HBO and topical HBO &
electrical stimulation
Prospective,
uncontrolled
Also see hyperbaric oxygen
133
Results
Limitations
No significant difference
between topical HBO
alone and topical HBO
with electrical stimulation
Larger, controlled study
to determine efficacy
needed
Recommendation based
on data from all chronic
wound types
Treatment Technical Report
Table 11. Growth Factors for Pressure Ulcer Treatment
References
Type of Study
Sample
Intervention(s)
Hirshberg J, Coleman J,
Marchant B, Rees RS.
TGF-beta3 in the
treatment of pressure
ulcers: a preliminary
report. Adv Skin
Wound Care.
2001;14(2):91-5.
Randomized, blind,
parallel, placebocontrolled trial (pilot
study)
N = 14 patients (6
women and 8 men) –
subset of the 270 study
participants
Each group received once
daily application of a topical
agent; Group 1 (N=4)
received 1.0 µg/cm² TGF-β3;
Group 2 (n = 5 received 2.5
µg/cm² TGF-β3 and Group 3
(N = 5) received placebo – the
topical agent ulcer in
conjunction with
standardized wound care for
16 weeks or until the ulcer
was healed
Randomized, doubleblind, placebocontrolled trial
N = 36 patients with
PrU of the foot
Baseline assessments were
done before randomization
during the first 2 weeks after
nursing home admission; 18
patients received 2.5S murine
nerve growth factor
treatment and 18 patient
received only conventional
topical treatment (balanced
salt solution) – 6 week
follow-up
Surface area – course of the
ulcers was evaluated by tracing
the perimeter of the wound
onto sterile transparent block
paper and determining the
stage
Prospective,
randomized, doubleblind trial
N = 44 completed the
study
N = 15 100 µg/ml aqueous
rPDGF-BB; N = 12 300 µg/ml
aqueous rPDGF-BB or
placebo (N = 14) and all
groups received saline gauze
dressings were applied daily
in addition to frequent
turning
Serial volume measurements of
the healing wounds were taken
using alginate molds
Evidence level = II
Landi F, Aloe L, Russo
A, Cesari M, Onder G,
Bonini S, et al. Topical
Treatment of Pressure
Ulcers with Nerve
Growth Factor. Ann
Intern Med.
2003;139(8):635.
Evidence level = II
Mustoe TA, Cutler NR,
Allman RM, Goode PS,
Deuel TF, Prause JA, et
al. A phase II study to
evaluate recombinant
platelet-derived
growth factor-BB in
the treatment of stage
3 and 4 pressure
ulcers. Arch Surg.
1994;129(2):213-9.
Outcome Measures &
Length of Follow-up
Reduction in pressure ulcer area
and volume
Evidence level = II
134
Results
Limitations
Only 8 patients completed the study; when
comparing group 3 with group 2
represented a significant reduction in the
mean relative surface area (p <.05); a
significant decrease in volume was seen
when comparing group 1 with group 3
(p<.05); the mean relative surface areas of
the target Pus at the termination of the trial
were as follows: Group 1 = 0.3 cm²; Group 2
= 0.4 cm² and Group 3 = 0.7 cm²; the mean
relative volumes at termination were as
follows: Group 1 = 0.7cm³, Group 2 = 0.2cm
³ and Group 3 = 0.3cm³ - the use of topical
growth factors is a progressive adjuvant to
the traditional treatment of Pus. The
potential benefits of growth factors include
faster closure rates, ease of application and
minimal adverse effects
After 6 weeks the mean area (± SD) of the
ulcers in the treatment group was 274 ±
329 mm² compared with 526 ± 334 mm² in
the control group (P = 0.022); reduction in
the PU area was 738 ± 393 mm² in the
treatment group and 485 ± 384 mm² in the
control group (P = 0.034); all of the ulcers
that were treated with topical application of
nerve growth factor showed a statistically
significant acceleration of the healing
process
Small sample size; 43%
of the patients did not
complete the trial; a
larger multicenter
blinded study is
required to explore the
potential benefits
The ulcers in the placebo group remained at
83%of the initial ulcer volume at day 29 of
the active-treatment phase while the ulcers
in the 100 - µg/ml and the 300 - µg/ml
treatment groups achieved 29% and 40% of
the initial volume respectively
Small sample size;
potential confounder in
the interpretation of the
results is the loss of 8
patients who did not
complete the activetreatment phase and
three patients without
determinations of day
29 ulcer volume;
Further studies are
warranted to better
understand the benefit
of topical nerve growth
factor treatment in
patients with chronic
skin ulcers
Treatment Technical Report
References
Type of Study
Sample
Intervention(s)
Pierce GF, Tarpley JE,
Allman RM, Goode PS,
Serdar CM, Morris B,
et al. Tissue repair
processes in healing
chronic pressure ulcers
treated with
recombinant plateletderived growth factor
BB. Am J Pathol.
1994;145(6):1399-410.
Multicenter,
randomized doubleblinded trial
N = 20
Prospective,
multicenter, doubleblind, parallel group,
placebo-controlled
trial
N = 124 (20 women;
104 men) – all
participants had to have
at least 1 but no more
than 3 chronic full
thickness (stage III or
IV) PUs
Patients were treated with
either placebo, rPDGF-BB
(100 µg/ml(1µg/cm²) or 300
µg/ml (3µg/cm²)) for 28 days;
3 mm full thickness punch
biopsies were collected
before treatment on day 0
and on days 8, 15, and 29
from approximately half of
the patients in the clinical
trial – biopsies were collected
for light microscopy at all
time points and Masson’s
staining was done on each
biopsy to evaluate fibroblast
content and size, neovessel
formation and collagen
staining, photomicrographs
of both Masson trichome and
Sirius red stains were taken
of all biopsies, sections were
also stained with an antibody
to the N-terminus of the type
I procollagen molecule
Before randomization the
target ulcer was debrided to
remove all nonviable tissue;
patients were randomly
assigned to 1 of 4 parallel
treatment groups: 1)
becaplermin gel 100 µg/g of
sodium
carboxymethylcellulose
vehicle gel (N = 31) once daily
alternating with placebo gel
every 12 hours; 2)
becaplermin gel 100 µg/g (N
= 30) once daily alternating
with placebo gel every 12
hours; 3) becaplermin gel 100
µg/g twice daily (N = 30) or 4)
placebo gel (N = 31) twice
daily; a thin layer of gel was
placed on the entire exposed
wound surface and the
Indirect evidence
Rees RS, Robson MC,
Smiell JM, Perry BH.
Becaplermin gel in the
treatment of pressure
ulcers: a phase II
randomized, doubleblind, placebocontrolled study.
Wound Repair Regen.
1999;7(3):141-7.
Evidence level = I
(also information in
this article related to
adverse event
including skin
ulceration; urinary
tract infection; skin
disorder etc. –did not
include this data here)
Outcome Measures &
Length of Follow-up
Volumetric and planmetric
measurements were obtained
weekly and were used to
determine whether ulcers were
healing or nonhealing
Results
Limitations
10 of the 13 ulcers in the treatment groups
were healing compared with 4 of 7 placebotreated ulcers; increase in fibroblast content
was detected in all rPDGF – BB treated
ulcers compared with placebo (2.81 ± 0.17
versus 2.05 ± 0.24, P = 0.01)
Small sample size
Relative ulcer volume – ulcer
volume at the end of the study
divided by the ulcer volume at
baseline; baseline volume
effect; complete healing
In the groups treated with either dose of
becaplermin gel once daily, the incidence of
complete healing was significantly greater
compared with that of placebo gel (23% and
19% for the 100 µg/g and 300 µg/g
becaplermin gel treatment groups
respectively, vs. 0% for the placebo gel
treatment group, p = 0.005 and p = 0.008
respectively); a similar difference was
observed in the incidence of ≥ 90% healing:
58% and 59% for the 100 µg/g and 300 µg/g
becaplermin gel treatment groups,
respectively, vs. 29% for the placebo gel
treatment, p = 0.021 and p = 0.014
respectively; the incidences of complete and
≥90% healing were 3% and 40%, respectively
in patients receiving becaplermin gel 100
µg/g twice daily; the median relative ulcer
volume at endpoint was 0.07 and 0.05 in the
becaplermin gel 100 µg/g and 300 µg/g
treatment groups, respectively compared by
Future studies are
warranted to address
issues such as effect of
becaplermin gel on
healthcare resource
utilization and patient
quality of life
135
Treatment Technical Report
References
Robson MC, Phillips
LG, Thomason A,
Robson LE, Pierce GF.
Platelet-derived
growth factor BB for
the treatment of
chronic pressure
ulcers. Lancet.
1992;339(8784):23-5.
Type of Study
Sample
Randomized, phase
I/II, double-blind,
placebo-controlled
study
N = 20 – each
participant had a stage
III or IV ulcer of area 25
– 95 cm²
Randomized, phase
I/II, double-blind,
placebo-controlled
study
N = 20 - each
participant had a stage
III or IV ulcer of area 25
– 95 cm²
Intervention(s)
Outcome Measures &
Length of Follow-up
wound was packed with
saline-moistened gauze; all
study sites received dressing
supplies to ensure a uniform
regimen; the second dressing
change occurred in a similar
fashion after rinsing the
wound surface with saline or
water; debridement of ulcers
to remove fibrin and necrotic
tissue was an important
component of good wound
care and was performed by
investigators during clinic
visits if necessary
Each participant was
randomly assigned to a
placebo group or rPDGF-BB
at 1 µg/ml and 10 µg/ml or
100 µg/ml; eligible
participants underwent
complete screening before
treatment; if debridement
was necessary the drug was
administered 48 hours later
Each participant was
randomly assigned to a
placebo group or rPDGF-BB
at 1 µg/ml and 10 µg/ml or
100 µg/ml daily for four
weeks – immediately before
application of the test
material each day the wound
was gently cleansed with
saline and then blotted dry
Limitations
the 0.27 in the placebo gel group (p = 0.013
and p = 0.011) respectively; median relative
ulcer volume at endpoint was 0.15 in the
group receiving becaplermin gel 100 µg/g
twice daily
Volume measurements of
pressure ulcers with alginate
molds were done on days 0, 7,
14, 21 and 29; other
measurements including
maximum depth crater, area of
ulcer opening and histology of
biopsy samples
Evidence level = II
Robson MC, Phillips
LG, Thomason A,
Altrock BW, Pence PC,
Heggers JP, et al.
Recombinant human
platelet-derived
growth factor-BB for
the treatment of
chronic pressure ulcers
[see comments]. Ann
Results
Hematology, serum chemistry
and urinalysis values were
evaluated on days 0, 3, 7, 14, 21
and 29 – measurements of the
pressure ulcer were performed
on days 0, 7, 14, 21, and 29
using maximum perpendicular
diameters of the surface and
maximum depth of the crater –
after discontinuation of
136
There were no significant differences in
ulcer volume at 29 days among patients
treated with 1 µg/ml and 10 µg/ml rPDGFBB or placebo; the 5 patients treated with
100 µg/ml rPDGF-BB had a better healing
response than the 7placebo – treated
patients; the mean (SE) volume of the ulcer
on day 29 was 6.4 (4.0)% of day 0 volume in
the rPDGF-BB treated patients compared
with 21.8 (5.6)% in the placebo-treated
patients (p = 0.12); histological examination
of biopsy samples from the ulcers showed
normal active wound-healing processes in all
groups, with no consistent differences in
cellular influx or extracellular matrix
deposition – However, the 100 µg/ml
rPDGF-BB group tended to have a greater
fibroblastic and endothelial cell influx and
consequently more provisional extracellular
matrix and new vessels
There was no clinically relevant differences
between patients treated with 1 µg/ml or 10
µg/ml rPDGF – BB or placebo in the
percentage of initial depth or volume
measured over time – the placebo and 1 and
10 µg/ml patients demonstrated
unexpectedly high rates of healing during
the trial however the 100 µg/ml of rPDGF –
BB had ulcers of clinically similar duration
and had a healing rate that was markedly
None listed
Small group size;
expanded trials are
warranted to determine
if these observations
are confirmed in larger
numbers of patients
having pressure ulcers
Treatment Technical Report
References
Type of Study
Sample
Plast Surg.
1992;29(3):193-201.
Evidence level = II
Outcome Measures &
Length of Follow-up
treatment patients were
discharged and evaluated at 2
weeks and 1, 2, 3, and 5 months
with a sterile gauze; after
application, the wound was
left open for 15 minutes to
permit absorption of rPDGFBB to the wound surface
Evidence level = II
Robson MC, Abdullah
A, Burns BF, Phillips
LG, Garrison L, Cowan
W, et al. Safety and
effect of topical
recombinant human
interleukin-1beta in
the management of
pressure sores. Wound
Repair Regen.
1994;2(3):177-81.
Intervention(s)
Prospective,
randomized, blind,
placebo-controlled
trial
N = 26 patients entered
the study and 24
patients completed the
study with pressure
sores extending from
the bone to the
subcutaneous tissue
(stage III – IV)
The volume applied was
based on the volumetrically
determined surface area; .01
ml/cm² which was measured
at baseline and then adjusted
weekly; the contents of the
drug were delivered by a
spray bottle after cleansing
with Normal Saline; the
wound was air0dried and a
saline solution-moistened
gauze dressing was applied
and changed 12 hours later;
three dosage tiers were
completed in groups of 8
patients (6 actively treated
and 2 treated with placebo
per dose); the dose levels
were: Tier 1: 0.01
µg/cm²/day; Tier 2: 0.1
µg/cm²/day; Tier 3: 1.0
µg/cm²/day
Measurements of the pressure
ulcer were performed on days 0,
7, 14, 21, 29 and at 1 and 3
months after drug application;
each ulcer received treatment
until it healed or for a maximum
of 28 days
137
Results
greater than that observed in the other
treatment groups; the depth of the ulcer on
day 29 was 14.1 ± 7.4% of the day 0 depth in
the 100 µg/ml – treated patients compared
with 34.9 ± 6.7% in the placebo-treated
patients; the 100 µg/ml group had an overall
two-fold decrease in ulcer depth
throughout the treatment period compared
with all other groups; treatment differences
were found between the 100 µg/ml dose
group and placebo and 10 µg/ml groups (p ≤
0.05); the volume of the ulcer on day 29 for
the 100 µg/ml treated patients was 6.4 ±
4.0% of the day 0 volume compared with
21.8 ± 5.6% in the placebo-treated patients;
overall differences in the percentage of
initial volume between groups were not
statistically significant (p = 0.16); however
the data from the 100 µg/ml demonstrated
1.6 to 2.2 fold decreases in overall volume
throughout the treatment period; 2 patients
in the 100 µg/ml group received complete
healing
No dose adjustments were required and no
patient required discontinuance of the drug
because of toxicity; no statistical difference
was found between initial sizes in the
placebo and the rhu IL-1β- treated groups;
no statistical significant differences were
seen in the percentage decreases in wound
volumes over the 29- day treatment
evaluation period were compared among
the various dosage groups or vehicle
placebo;
Limitations
None listed
Treatment Technical Report
References
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Results
Limitations
Robson MC, Hill DP,
Smith PD, Wang X,
Meyer-Siegler K, Ko F,
et al. Sequential
cytokine therapy for
pressure ulcers: clinical
and mechanistic
response. Ann Surg.
2000;231(4):600-11.
A masked,
randomized pressure
ulcer trial
N = 61 inpatient’s
completed the 35-day
acute phase of the trial
with pressure ulcers
involving any tissue
from a bony
prominence to the
subcutaneous tissue
(grade III/IV)
Each of the patients were
randomized to one of four
treatment regimens: N = 15
received 2.0 µg/cm² GM-CSF
topically applied daily for 35
days; N = 15 received 5.0
µg/cm² bFGF topically
applied daily for 35 days; N =
16 received 2.0 µg/cm² GMCSF applied for 10 days
followed sequentially by 25
days of topically applied 5.0
µg/cm² bFGF; or the N = 15
received comparative
placebos applied for 35 days
– the amount of topical
substance for each week of
treatment was based on a
volumetrically determined
surface area at baseline and
on study days 7, 14, 21, and
28
The pressure ulcer was
measured on day 0 and weekly
for 5 weeks using planimetry of
the ulcer opening and volume
determination using alginate
molds;
Day 0 Ulcer Volume (cm³)
Mean ± SD/Median (range)
- All patients (N = 61) :
37.49 ± 30.59/26.37(9.82-153.72)
- GM-CSF (N = 15):
32.77 ± 21.06/27.52 (10.27-83.01)
- bFGF (N = 15)
33.81 ± 26.12/23.54 (9.82-100.35)
- Sequential GM-CSF/bFGF (N = 16)
38.16 ± 38.3/25.88 (10.00-153.72)
- Placebo (N = 15)
45.19 ± 34.79/41.15 (10.44-116.73
P-Value for Median = 0.84
None listed
Evidence level = I
Day 36 Ulcer Volume (cm³)
Mean ± SD/Median (range)
- All patients (N = 61) :
12.65 ± 16.24/7.26 (0.22-99.65)
- GM-CSF (N = 15):
12.02 ± 11.88/9.29 (0.88-40.62)
- bFGF (N = 15)
7.24 ± 6.11/4.42 (0.22-20.80)
- Sequential GM-CSF/bFGF (N = 16)
16.83 ± 25.75/7.48 (0.22-99.65)
- Placebo (N = 15)
14.24 ± 13.66/8.85 (2.12-45.84)
P-Value for Median = 0.57
% Wound Closure on Day 36
Mean ± SD/Median (range)
- All patients (N = 61) :
70 ± 19/73 (3-99)
- GM-CSF (N = 15):
67 ± 24/70 (3-93)
- bFGF (N = 15)
75 ± 19/79 (42-99)
- Sequential GM-CSF/bFGF (N = 16)
68 ± 21/73 (29-98)
- Placebo (N = 15)
71 ± 11/72 (39-84)
P-Value for Median = 0.69
When patients receiving any cytokine
138
Treatment Technical Report
References
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Results
therapy were compared with patients
receiving placebo vehicles, significantly
more patients treated with cytokine
achieved a more than 85% decrease in ulcer
volume (P = .03); the bFGF-alone group had
significantly more patients than the placebo
alone group with more than 85% closure (P
= .02) and more than 90% closure (P = .04;
the sequential cytokine therapy reached a
significance level of P = .10 compared with
placebo at more than 85% healing; the
patients treated with GM-CSF alone did not
respond significantly better than placebotreated patients at more than 85% closure
(P = 0.22)
139
Limitations
Treatment Technical Report
Table 12. Surgery for Pressure Ulcers
Direct Evidence
Reference
Type of Study
Sample
Intervention(s)
Akan IM, Ulusoy MG,
Bilen BT, Kapucu MR.
Modified bilateral
advancement flap: the
slide-in flap. Ann Plast
Surg. 1999;42(5):5458.
Between 1995 and
1997 10 patients
received this revised
V-Y advancement
flap design.
Age range was 5 – 70
years, and follow-up
ranged from 6 – 12
months. Defect size
ranged from 4 – 20
cm. Defect locations
were sacrum (7), and
one each on hand,
thigh, and forehead.
Five defects were
pressure sore
related, 2 were from
basal cell carcinoma,
two from
meningomyelocele
and the youngest
was from a skin
defect.
Lumbosacral defects
on 20 patients were
covered with a
perforator-based flap
between December
1995 to January
1997. 10 males and
10 females, age
range 31 – 95 years.
Defect size ranged
from 5 X 5 cm to 11 X
17 cm. No average
given.
Case Reports
The standard V-Y flap design
was modified somewhat with
the height of the V flaps
measuring 1.5 – 2 times the
diameter of the defect. The
limbs of the flap were curved
outward slightly making the
flap and its two extensions
broader than the standard VY flap. Both upper and lower
extensions of the V flap were
then pulled into position and
sutured to the concave base
of the Y flap. The limbs of
the Y flap were sutured to
the outside of the two V flaps
respectively, and the V flaps
were sutured together in the
center.
Case Reports
Shape and size of the donor
flap depended on size of
defect. Also harvest site
depended on location of
defect. Perforator-based
flaps were used rather than
musculo-cutaneous flaps as
to preserve the muscle tissue
intact, and in case of repeat
sore to leave that option
open for a repeat surgery.
Ao M, Mae O, Namba
Y, Asagoe K.
Perforator-based flap
for coverage of
lumbosacral defects.
Plast Reconstr Surg.
1998;101(4):987-91.
Outcome Measures &
Length of Follow-up
All wounds closed successfully,
without necrosis or wound
dehiscence.
Results
Limitations
No statistics given, but successful repair and
healing of all defects resulted.
Efficient redistribution
of available tissue by
the combined use of
transposition and
advancement
principles resulted in
the repair of relatively
large skin defects with
reduced tension along
the closure.
Pressure sore coverage and flap
healing in all cases.
No statistics were given. One had a minor
fistula, one partial necrosis, two had
marginal necrosis, and one had infection. All
survived and healed.
Authors showed a
variety of flap design is
possible, such as trilobed, quadric-lobed,
step-ladder fashion,
fusiform, or elliptical.
Advantages are rich
vasculature to
facilitate transfer by
means of large flap
based on one or
several perforators
compared with
conventional skin
flaps. Adaptability of
flap design to defect,
easy donor site skin
closure not requiring
140
Treatment Technical Report
Reference
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Results
Aslan G, Tuncali D,
Bingul F, Ates L, Yavuz
N. The "duck"
modification of the
tensor fascia lata flap.
Ann Plast Surg.
2005;54(6):637-9.
27 patients with
trochanter pressure
sores treated for
total of 31 flaps. 15
Right sided, 16 left
sided, 4 bilateral.
Average age 51 years
(range 19 – 76). All
patients either
quadriplegic (8) or
paraplegic (19).
Average defect
requiring coverage
was 11 X 9 cm (range
9 X 7 to 14 X 11 cm).
Case Reports
The “duck beak” modification
of the tensor fascia flap is
used to transition the closure
of the flap harvest site to the
flaps new location. Drains
inserted and removed day 3.
Successful covering of all 31
trochanteric pressure sores.
31 flaps successful. Average hospitalization
of 14 days (range 5 – 21 days) . Average
follow-up time 13 months
Ay A, Aytekin O,
Aytekin A.
Interdigitating
fasciocutaneous
gluteal V-Y
advancement flaps for
reconstruction of
sacral defects. Ann
Plast Surg.
2003;50(6):636-8.
14 patients with
sacral pressure sores
and 1 patient with a
chronic pilonidal
sinus.
4 female and 11
males, mean 38.2
years (range 16-57).
Mean diameter of
sacral defect 13.6
cm. (range 10 cm –
17 cm).
Mean follow-up was
6 months (range 6-16
months).
From 1995 to 1997,
30 patients (18
female and 12 male)
were included. 17
were ambulatory, 13
paraplegic and
bedridden. 36 flaps
Case Reports
The V-Y advancement
procedure was used. Flap
incision down to the facia of
the gluteal maximus but
muscle is preserved. Drains
inserted, removed day 3,
sutures removed after 14 to
18 days postoperatively.
Healed ulcer and flap
All flaps survived and healed without major
problems. One flap with superficial necrosis
at distal end of one arm of the flap. Healed
without secondary operation.
Case Reports
Elliptical gluteal maximus
flaps taken from sites near
the ulcer were used in all
patients. Muscle mass of ½
the depth of total gluteal
maximus muscle taken from
flap site.
Healed pressure ulcers.
Three patients lost to follow-up. Of followup patients all flaps healed. One required a
second reconstruction due to necrosis, one
with wound infection closed the site by
secondary healing.
Baran CN, Celebioğlu
S, Civelek B, Sensöz O.
Tangentially split
gluteus maximus
myocutaneous island
flap based on
perforator arteries for
141
Limitations
skin grafting, and nonsacrifice of underlying
muscle.
The flap is reliable and
easily designed.
Formation of dead
space and the coneshaped dog-ear
deformity due to
rotation is prevented.
Better esthetic results
are achieved.
Suture separation is
prevented via a
tension-free closure.
The de-epithelialized
part produces tight
attachment of the flap
to the recipient bed.
No muscle tissue is
included so the flap is
more resistant to
pressure.
Digitizing the middle VY vascio-cutaneous
flap avoids a straight
line closure and the
resulting functional
defect.
No mention of postoperative treatments
used
Treatment Technical Report
Reference
Type of Study
the reconstruction of
pressure sores. Plast
Reconstr Surg.
1999;103(7):2071.
were surgically
placed. Some
patients had more
than one ulcer.
20 sacral, 8
trochanter, and 8
ischial ulcers were
included.
18 month
postoperative followup period with
regular checkups.
Between 1998 and
2001, 15 patients (11
male, 4 female) with
decubitus ulcers
surgically repaired
using gluteal fasciocutaneous rotationadvancement flaps
with V-Y closure.
Mean age 48.2 years
(range 34-84).
All ulcers stage IV.
Between 4 to 18 cm.
(mean 9.3).
10 patients with
assorted tissue
defects of the ankle
of foot region,
treated with 11
reverse sural artery
flaps.
Etiology factors were
pressure sores (4)
postsurgical
debridement (3)
trauma (3).
All procedures
performed by same
surgeon.
Borman H, Maral T.
The gluteal
fasciocutaneous
rotation-advancement
flap with V-Y closure in
the management of
sacral pressure sores.
Plast Reconstr Surg.
2002;109(7):2325-9.
Buluc L, Tosun B, Sen
C, Sarlak AY. A
modified technique for
transposition of the
reverse sural artery
flap. Plast Reconstr
Surg.
2006;117(7):2488-92.
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Results
Limitations
Case Reports
Debride ulcer and underlying
bone as necessary. Using the
V-Y advancement flap ulcers
were surgically repaired, with
suctions drains used in all 15
surgical sites.
All patients healed with need
for further surgery
1.5 to 35 month follow-ups all flaps healed
and survived.
The technique is
simple, can be
performed quickly, has
minimal associated
morbidity, and yields a
good outcome.
Case Reports
The reverse flaps were taken
above the sore, and
positioned on the ulcer after
transport through a
subcutaneous tunnel.
Healed ulcers.
8 flaps survived completely. Partial skin loss
and distal tip necrosis in the two diabetic
patients.
The reverse sural
artery flap is a reliable
alternative for small to
moderate size defects
and can be used with
modifications of the
original technique.
Mean age was 44
years (range 10 –
75).
142
Treatment Technical Report
Reference
Type of Study
Sample
Intervention(s)
Chen TH. Bilateral
gluteus maximus V-Y
advancement
musculo-cutaneous
flaps for the coverage
of large sacral pressure
sores: revisit and
refinement. Ann Plast
Surg. 1995;35(5):4927.
Coşkunfirat OK,
Ozgentaş HE. Gluteal
perforator flaps for
coverage of pressure
sores at various
locations. Plast
Reconstr Surg.
2004;113(7):2012.
63 consecutive
patients undergoing
bilateral gluteus
maximus V-Y
advancement
musculo-cutaneous
flaps with
refinements.
Case Reports
63 patients undergoing the
V-Y refinement surgery.
Follow-up period of 28
months (range 6-62 months).
Average hospital stay was
38.5 days.
32 patients, 16 men
and 16 women,
operated on
between Nov. 1998
and June 2002 on
pressure sores at
various sites. Mean
age of 53.1 years
(range 5 to 87 years).
All grade III or IV per
Shea classification.
22 sacral, 7 ischial, 6
trochanter. 18
patients plegic, and 5
bedridden.
114 consecutive
patients undergoing
flap coverage of 139
ischial pressure sores
between 1979 and
1995
Case Reports
Case Reports
22 consecutive
elderly patients with
27 pressure sores
operated on
between 1995 and
1998 by the same
surgeon.
Case Reports
Foster RD, Anthony JP,
Mathes SJ, Hoffman
WY. Ischial pressure
sore coverage: a
rationale for flap
selection. Br J Plast
Surg. 1997;50(5):3749.
Gusenoff JA, Redett RJ,
Nahabedian MY.
Outcomes for surgical
coverage of pressure
sores in
nonambulatory,
nonparaplegic, elderly
patients. Ann Plast
Outcome Measures &
Length of Follow-up
Repair of ulcer and healing.
Results
Limitations
93% or 59 patients achieved complete
healing. 4 patients had recurrent sacral
sores.
4 patients (6%) had dehiscence requiring
skin grafting, 9 patients (16%) had wound
infections without loss of flap.
No significant
functional impairment
related to the flap
procedure was noted.
32 patients were followed for
a mean of 13.6 months
(range 0 to 38 months). One
patient died from pulmonary
emboli, two from MI’s .
Healing of all flaps
One flap totally necrosed (2.9%) performed
on a patient right after a CABG on
anticoagulants.
One recurrence (2.9%) after 5 months
repaired and healed post second surgery.
All flaps healed except one, even in diabetic
and atherosclerotic patients.
No inclusion or
exclusion criteria
presented.
Freedom in flap design
and low donor-site
morbidity make the
gluteal perforator flaps
and excellent choice
for pressure sore
coverage.
Detailed information
collected from 112 flaps in 87
unselected patients from the
initial 114 patients. 64 men
and 23 women, mean age
49years (range 16 – 90).
89% were paraplegic, 4%
quadriplegic, and 7%
ambulatory.
Follow-up ranged from one
month to 9 years, average
10.7 months.
Patients categorized into
three groups based on ulcer
location: sacrum, trochanter,
or ischium.
19 sacral ulcers, 7 trochanter
ulcers, and 1 ischial ulcer.
Four patients had both sacral
and trochanter ulcers and
Flap success and primary
healing were defined as a
healed wound within one
month postoperatively.
89% healed primarily.
For flap with the greatest significant
experience, (greater than 10 cases), the
inferior gluteus maximus island flap and the
inferior gluteal thigh flap had the highest
success rates, 94% and 93% respectively.
Average hospital stay was 21 days, average
time to heal was 38 days. Earliest time
healing could occur, as described in study,
was 28 days, at time of suture removal.
When flaps failed to
heal it was usually the
result of partial flap
necrosis (n=10)
inadequate
debridement and
subsequent failure to
control infection (n=5)
or wound dehiscence
(n=5).
Over all there were 11
complications of the 22 patients
(50%). Well healed flap present
in 19 of the 27 ulcers (70%) at
the average follow-up of 6
months.
Of the 22 patients, 4 were lost to follow-up.
9 of the 19 (47%) had initial well healed
ulcers at 6 months, 3 patients, (16%) healed
by secondary intention, two had poor
wound healing (11%) and 4 patients (21%)
were lost to follow-up. One patient had a
recurrence 6 months after initial repair.
Trochanter group had 7 patients, three men
Patient selection is
critical to the outcome
of surgical treatment
for pressure sores.
Comprehensive
postoperative
rehabilitation is
essential.
143
Treatment Technical Report
Reference
Type of Study
Surg. 2002;48(6):63340.
Sacral group of 11
men and 8 women,
mean age 61. 14
were nonambulatory, 2 very
poor ambulatory,
and 3 ambulatory.
16 stage IV ulcers
and 3 stage III.
Of the 22 patients, 4
were lost to followup. Average followup of the remaining
18 was 6 months
(range 3 months to 2
years).
Sample
Homma K, Murakami
G, Fujioka H, Fujita T,
Imai A, Ezoe K.
Treatment of ischial
pressure ulcers with a
posteromedial thigh
fasciocutaneous flap.
Plast Reconstr Surg.
2001;108(7):1990.
Case Reports
11 pressure ulcers in 10
paraplegic patients
surgically repaired
Ichioka S, Okabe K,
Tsuji S, Ohura N,
Nakatsuka T. Distal
perforator-based
fasciocutaneous V-Y
flap for treatment of
sacral pressure ulcers.
Plast Reconstr Surg.
2004;114(4):906-9.-5.
Since 1993,
management of 32
patients (21 men and
10 women). Mean
age 62.3 years (range
20-88 years). All
stage IV ulcers, mean
defect size of 10.8
cm, (range 8-16 cm).
All reconstructed
with a unilateral flap.
Average follow-up
period was 54.8
months (range 3-124
months).
Case Reports
Intervention(s)
Outcome Measures &
Length of Follow-up
one had both trochanter and
ischial, making a total of 27
ulcers in 22 patients.
Mean age was 59 years
(range, 50-82).
Inclusion criteria were
motivation, clean wounds
with signs of healing, normal
albumin and nitrogen
balance, and control of
spasticity if present.
Exclusion criteria included
flexion contractures near the
area of reconstruction,
vascular disease
compromising the flaps or
wound healing, and poor
nutritional status.
Surgical repair of ulcers using
a Posteromedial Thigh
Fasciocutaneous Flap.
Surgeries performed
between May 1986 and
January 1999. Seven male
and three females age range
30 to 74 years (average 52.5).
Postoperative follow-up
period ranged from 16
months to 14 years, (average,
77 months).
This technique used in
defects greater than 8 cm
only as those could be
covered with standard V-Y
flaps without distal muscular
incisions.
Results
Limitations
and four women, mean age 66 years, all noambulatory with grade IV ulcers.
No complications, 100% excellent outcomes
at 6 months follow-up.
Ischial patient, a 50 year old paraplegic, had
a grade IV sacral and a grade IV ischial ulcer.
Postoperative dehiscence with revision.
Final outcome excellent healing.
Flap selection must
not only cover the
wound but leave
options for recurrent
ulcers and other flap
options.
All flaps survived and healed.
After average follow-up time of 77 months,
no recurrence in 7 of the 11 closures.
Pressure sore free period of 46 months in
the recurrent group, and 68 months in the
non-recurrent group.
Overall pressure sore free period is 5 years.
Of the 11 flaps, two
experienced viability
problems. Losses from
failure to properly
include the perforator.
Conclusion that width
of the flap should be
greater than 5 cm.
Covered ulcers and healed flaps
with minimal functional deficit.
Overall 93.5% of the flaps healed primarily.
Two had early postop dehiscence with one
requiring secondary suturing 18 days after
first operation. These wounds healed
uneventfully in the postop period.
This variation of the
unilateral flap is very
useful in the coverage
of large ulcers.
144
It is imperative
postoperative care be
utilized to prevent
recurrence.
Treatment Technical Report
Reference
Type of Study
Sample
Intervention(s)
Ichioka S, Okabe K,
Tsuji S, Ohura N,
Nakatsuka T. Triple
coverage of ischial
ulcers with
adipofascial turnover
and fasciocutaneous
flaps. Plast Reconstr
Surg. 2004;114(4):9015.
17 male and 5
female patients were
treated. Mean age
46.3 years (range 2784 years). 17
patients were
paraplegic, one was
quadriplegic, four
with cerebral
infarction, spina
bifida, and multiple
sclerosis.
All patients had stage
IV ulcers.
Case Reports
After debridement of the
area, the skin overlying each
flap is undermined leaving an
adequate thickness of
subcutaneous tissue beneath.
The adiposfascial flaps are
dissected from the
underlying muscle then
turned over in a manner so as
to overlap each other to
cover the exposed bone. A
local fasciocutaneous flap is
then applied to the raw
surface of the turned over
flaps in a manner to cover
the area.
Ishida LH, Munhoz AM,
Montag E, Alves HRN,
Saito FL, Nakamoto
HA, et al. Tensor
fasciae latae
perforator flap:
minimizing donor-site
morbidity in the
treatment of
trochanteric pressure
sores. Plast Reconstr
Surg.
2005;116(5):1346-52.
24 fresh cadavers
were dissected.
21 patients
underwent a clinical
study between
January 1999 and
November 2003
where 22 tensor
fasciae latae
perforator flaps were
performed, one
bilaterally.
Mean age 40 (range
19-70 years).
19 patients
paraplegic and 2
paraparetic.
Mean ulcer size was
6.65 X 6.54 cm.
Mean flap size was
7.5 X 13.22 cm.
Ulcer size ranged
from 4 X 5 cm to 5 X
Case Reports
The cadaver dissections were
used to mark parameters for
the location of perforators
larger than 1 mm. in an area
marked by anatomical
locators defined as A.)
Anteriorsuperior iliac spine,
B.) Lateral margin of the
Patella, C.) pubis, and D.) the
trochanter prominence.
Two axis were designated,
axis X , running between
points A and B and axis Y
delineating points C and D. A
10 cm arc around point D was
lifted and the perforators
marked and tabled
coordinates were then used
to find same in the live
clinical patients.
Outcome Measures &
Length of Follow-up
Healed flaps
Results
Limitations
Overall 86.4% of the flaps (19 out of 22)
healed primarily.
Average follow-up period was 77 months
(range 1 – 159 months)
Three patients had complications including
wound infection, partial fat necrosis, and
seroma. These healed conservatively within
a 5 week period postoperatively.
One patient with MS had superficial
epidermolysis at the second postoperative
month that improved conservatively.
One patient with cerebral infarct developed
a recurrent subcutaneous pocket 2 months
post-surgery. Negative pressure therapy for
2 weeks conservatively obliterated the
subcutaneous cavity.
Coverage and healing of the
flaps was observed.
Two flaps experienced donor site wound
dehiscence with subsequent would dressing
changes till healed
Average drainage time was three days.
No other complications were reported.
No statistics were reported.
Triple coverage with
the combination of
double adipofascial
turnover flaps and a
local fasciocutaneous
flap allows for an
easily performed and
minimally invasive
procedure,
preservation of future
flap options, and a
soft-tissue supply
sufficient for covering
bony prominence and
filling dead space.
This technique
provides successful
soft-tissue
reconstruction for
minor to moderatesized ischial pressure
ulcers.
Main disadvantage of
this flap reported to be
the fragility of its
pedicle demanding
more attention on the
part of the surgeon
when positioning the
flap to prevent pedicle
tension.
This flap an alternative
to myocutaneous flaps
as it preserves local
musculature without
functional sequelae in
ambulatory patients,
and preserves
musculature in event
of recurrence, as is
usually seen in
paralytic patients.
145
Treatment Technical Report
Reference
Jósvay J, Sashegyi M,
Kelemen P, Donáth A.
Clinical experience
with the hatchetshaped gluteus
maximus musculocutaneous flap. Ann
Plast Surg.
2005;55(2):179-82.
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Results
Limitations
10 cm.
Of the 22 flaps, 17
had 1 or 2
perforators, three
had 3 perforators
and the largest flap
had 21 perforators
intact for a mean of
1.81.
Between January
1998 and December
2003 this method
was used on 54
patients and 71 total
flaps.
Age ranged from 10
weeks to 72 years.
Follow-up period was
10 to 64 months.
Case Reports
This procedure was used on
31 patients with sacral
decubitus ulcers, ischial
ulcers on 12 patients,
trochanter ulcer on one
patient. Later in the study
used on nondecubitus
defects such as
myelomeningocele (4 pts.)
Crohn disease (3 pts.)
pilonidal sinus (2 pts.) and
traumatic defect on one pts.
Despite the few complications,
all but two flaps healed and
ulcers covered successfully.
Two relapsed, were treated at
another institution, and were
not included in follow-up
Seroma (4,) hematoma (2), Postoperative
bleeding (1), and partial flap necrosis (1)
healed following emptying and repeated
surgery.
Recurrent ulcer was seen in 2 cases.
Postoperative bleed was surgically repaired
day 7, and subsequently healed.
Seroma and hematoma all cleaned and
patent healed.
Crohn's disease patient had flap edge
necrosis and wound dehiscence, later
surgically repaired and healed.
One sacral and one ischial pressure ulcer
relapsed and these were re-operated on at
another institution.
Advantages are fewer
incisions needed,
shorter operating
time, and smaller
blood loss as
compared with
methods known so far.
The new incision
direction improves the
safety of the
circulation in the flap,
the closure of the
donor site is simpler,
and no contour
difference remains in
the surgical area.
Jósvay J, Donáth A.
Modified hamstring
musculocutaneous flap
for the coverage of
ischial pressure sores.
Plast Reconstr Surg.
1999;103(6):1715-8.
Report of a V-Y
advancement of the
hamstring muscles
and overlying skin on
one 18 year old
patient born with
spina bifida and
paraplegic since
birth.
Case Report
Not an actual study.
Healed and covered ulcer
Complete healing and non-recurrence of
the ischial sore on this patient.
This type of procedure was performed on 10
other patients with 11 (one bilateral) for
similar results. Healing was undisturbed in
all patients without recurrence, even after
loading.
Most recent of these 11 surgeries was 6
months ago at time of report.
Koladi J, Gang RK,
Hamza AA, George A,
Bang RL, Rajacic N.
Versatility of the
distally based
superficial sural flap
for reconstruction of
From June 1998 to
June 2000 20
children between
ages 1 and 12 (mean
6 years) underwent a
distally based
superficial sural flap
Case Reports
Two cases involved open
joint injuries, six involved
dorsum of the foot with
exposed tendons, three
occurred in the weight
bearing heel region, and two
had definite epiphyseal
Healed defect with functionality
One wound with infection, one with partial
flap necrosis.
146
Distally based
superficial sural flap
has advantages of
being easy to perform,
short operating time,
minimal donor site
morbidity, and
Treatment Technical Report
Reference
Type of Study
lower leg and foot in
children. J Pediatr
Orthop.
2003;23(2):194-8.
for coverage of
defects at the lower
leg and foot.
Mean follow-up was
2 years
15 patients had
trauma to the lower
leg, 3 had post burn
contracture, 2 had
pressure sores.
Flap size from 3 X 4
to 8 X 10 cm.
not all subjects had
PrU
Ohjimi H, Ogata K,
Setsu Y, Haraga I.
Modification of the
gluteus maximus V-Y
advancement flap for
sacral ulcers: the
gluteal
fasciocutaneous flap
method. Plast
Reconstr Surg.
1996;98(7):1247-52.
Not all subjects had
PrU
Rajacic N, Gang RK,
Dashti H, Behbehani A.
Treatment of ischial
pressure sores with an
inferior gluteus
24 patients with
sacral ulcers treated
with this variation of
the V-Y flap.
19 had sacral
pressure ulcers, 2
had radiation ulcer.
18 of the group were
ambulatory.
Age range from 20 to
91 years.
Mean defect size was
9 cm (range 5 to 15
cm in transverse
diameter)
Follow-up mean was
24.3 months (range 2
to 60 months).
Average blood loss
was 250 ml during
surgery.
37 paraplegic
patients with 31
ischial pressure sores
of moderate size.
31 consecutive
Sample
Case Reports
All treated by using an
island gluteus maximus
musculocutaneous flap
of the most inferior part
of the muscle based on
Intervention(s)
Outcome Measures &
Length of Follow-up
injuries.
Fasciocutaneous flap was
used in 14 cases and a fascial
flap covered with skin graft in
6 cases.
Treatment of acute trauma
included radical wound
debridement followed by a
distally based superficial sural
flap. In 8 cases the flap was
performed immediately after
debridement, in 12 others
defects were covered within
the first week of injury.
Three had simultaneous
tendon reconstruction and 7
patients with underlying
fractures required bone
fixation.
Defects with average size of
6.7 X 7.6 cm were
reconstructed with unilateral
gluteal fasciocutaneous flaps
Defects of average size of
11.2 X 11.1 cm were
reconstructed with a bilateral
gluteal fasciocutaneous flaps.
Description of experience
Results
Limitations
preservation of major
arteries of the leg.
Healed defect without
functional deficit
No flap necrosis and no functional deficit in
any of the ambulatory patients followed up
over one year.
Recurrent wound infections in three
patients after surgery. All healed with
secondary treatment.
Two patients died or original condition.
The gluteal
fasciocutaneous flap
method for sacral
defects decreases
blood loss and
shortens the operating
time during surgery
compare with the
conventional gluteus
maximus musculocutaneous flap
methods.
Complete healing of both
surgical and donor sites.
One patient died of sepsis not related to the
flap
All patients treated achieved complete
healing of the surgery site and donor sites at
time of hospital discharge.
Experience with this
group suggests that
the inferior gluteus
maximus island flap is
a very useful method
147
Treatment Technical Report
Reference
Type of Study
Sample
maximus
musculocutaneous
island flap: an analysis
of 31 flaps. Br J Plast
Surg. 1994;47(6):4314.
ischial wounds.
20 males and 7
females
Age mean of 35 years
(range 15 to 47
years).
All patients suffered
from post-traumatic
paraplegia, 4 of
which had
undergone earlier
attempts at wound
closure.
Rubayi S, Doyle BS.
The gluteus maximus
muscle-splitting
myocutaneous flap for
treatment of sacral
and coccygeal pressure
ulcers. Plast Reconstr
Surg. 1995;96(6):136671.
28 patients with
stage IV sacral or
coccygeal pressure
ulcers.
Mean defect size 4 X
4 cm.
Mean follow-up of 15
months (range 2 to
40 months).
20 males and 8
females age range 14
to 78 years (mean
age 36 years).
Average time from
onset of ulcer and
surgery was 6
months.
21 sacral ulcers, 7
coccygeal ulcers.
Average size of ulcer
at surgery was 4 X 4
cm (range 2 x 2 to 10
X 10cm).
All patients followed
in hospital for
minimum of 8 weeks.
branches of the inferior
gluteal artery.
Postoperatively all
patients were entirely
non-weight bearing for
2 weeks with airflotation beds, then
transferred to regular
bed for another 3
weeks and kept off the
operation site.
26 patients followed for
an average of 12
months (range 6 – 32
months).
Mean hospital period
after closure was 40
days.
Case Reports
Intervention(s)
Outcome Measures &
Length of Follow-up
The gluteus maximus muscle
is split in this study
Healing and closure of wounds
148
Results
Limitations
2 had complications related to inadequate
excision of the sore with minor infection,
healed spontaneously.
6 cases had partial dehiscence of the donor
site. Three healed spontaneously, in 2 a
secondary revision of the wound was done
to accelerate healing, recurrence of
bedsores occurred in three patients
between 6 and 13 months after surgery.
These required another surgical flap
of providing soft tissue
coverage for minor to
moderate-sized ischial
pressure sores.
The number of donor
site complications
indicates the need for
tension-free closure
with better
obliteration of the
secondary “dead”
space and proper
drainage.
27 patients achieved complete healing at
final follow-up.
One patient died 12 months postoperatively
of medical causes.
Complications occurred in 7 patients. 4
patients had either breakdown of the flap or
superficial wound dehiscence within the first
6 weeks. One had a revision of the flap, one
had a split thickness skin graft to close the
defect, and 2 patients wounds healed by
secondary intention.
3 patients had breakdown of the flap site
occurring 6, 11, and 16 months
postoperatively. One had a flap revision,
one healed secondarily with wound care,
and one refused further surgery and did not
follow-up after.
Advantages of the
gluteal maximus
muscle-splitting
myocutaneous flap
include reduced blood
loss, preservation of
most of the gluteus
maximus for future
use, and retained
function of the gluteus
maximus for stair
climbing and singlelimb support in the
ambulatory patient.
Treatment Technical Report
Reference
Type of Study
Sample
Intervention(s)
Scheufler O, Farhadi J,
Kovach SJ, Kukies S,
Pierer G, Levin LS, et
al. Anatomical basis
and clinical application
of the infragluteal
perforator flap. Plast
Reconstr Surg.
2006;118(6):1389-400.
13 patients, 11 men
and 2 women, mean
age 47 (range 33 to
68 years).
9 ischial ulcers, 3
sacral, 1
trochanteric.
Mean ulcer size at
time of surgery 44.6
cm X 14.2 cm (range
25 to 64 cm).
All ulcers grade IV of
V.
Divided into two
groups, Group A
perforator-based flap
reconstruction and
Group B perforator
flap reconstruction.
Case Reports
This flap is designed to
minimize donor-site
morbidity by sparing the
gluteal muscle and primary
closure of the donor site,
leaving a scar that avoids
maximal pressure zones over
bony prominences. The
surgeries in these reports
were done in such a manner.
Case Reports
Surgeries done for coverage
of complicated severe
wounds. The vastus lateralis
flap is classically a salvage
procedure to deal with a
second, third, or later
recurrence of a pressure sore
and all conventional flaps are
no longer possible. This
study demonstrated various
possible uses for this flap and
its versatility for complicated
wound coverage.
Schmidt AB, Fromberg
G, Ruidisch MH.
Applications of the
pedicled vastus
lateralis flap for
patients with
complicated pressure
sores. Spinal Cord.
1997;35(7):437-42.
Mean operating time
Group A was 94
minutes (range 80 to
120 minutes).
Mean operating time
Group B 137 minutes
(range 90 to 200
minutes).
Donor sites all closed
primarily.
From 1988 to 1995
38 vastus lateral
flaps were
performed.
Average age 43
(range 17 to 72
years).
Follow-up mean 14
months (range 4 – 48
months).
Outcome Measures &
Length of Follow-up
Coverage of wound and total
healing.
Results
Limitations
12 of 13 flaps healed uneventfully.
One flap from Group B necrosed totally.
This elderly patient had multiple scars
adjacent to the flap donor site following
several operations for ischial pressure sore
recurrence.
In all cadaver and
clinical dissections one
or two cutaneous
branches of the
descending branch of
the inferior gluteal
artery and one or two
nerves were found at
the lower border of
the gluteus maximus
muscle supplying the
infragluteal perforator
flap. These provided
flaps with more
mobility compared
with perforator based
flaps and spared the
descending branch of
the inferior gluteal
artery for future flaps
if necessary.
Covered wound and healed
sites
In 24 patients healing was uneventful.
Impaired healing at the recipient site
required operative revision. Donor site
complications requiring split skin grafting
occurred in 4 patients. Multiple
complications occurred in three patients.
The
musculocutaneous
vastus lateralis flap is
important in the
treatment of
complicated recurrent
pressure sores and
defects after vascular
occlusion at iliac level.
The disadvantages of
some blood loss and
slightly difficult
dissection are
outweighed by the
advantages of a big arc
Complications included flap necrosis (1),
partial flap necrosis (1), delayed healing
recipient site (7), delayed healing donor site
(4), recurrence of pressure sore (1),
recurrence of osteitis (2), pain of donor site
in rehabilitation (1).
One electrical burn patient died one week
149
Treatment Technical Report
Reference
Tavakoli K, Rutkowski
S, Cope C, Hassall M,
Barnett R, Richards M,
et al. Recurrence rates
of ischial sores in paraand tetraplegics
treated with hamstring
flaps: an 8-year study.
Br J Plast Surg.
1999;52(6):476-9.
Tunçbilek G, Nasir S,
Ozkan O, Kayikçioğlu
A, Mavili E. Partially
de-epithelialized and
buried V-Y
advancement flap for
reconstruction of
sacrococcygeal and
ischial defects. Scand J
Plast Reconstr Surg
Type of Study
Follow-up or 27
patients who
underwent
musculocutaneous
flap closure of their
ischial pressure
sores.
37 ulcers treated
between 1988 and
1993 using a V-Y
advancement
hamstring
musculocutaneous
island flap.
Initial follow-up in
1993, mean period
20 months.
Second follow-up
1997 mean period 62
months (range 18 to
90 months)
Mean age second
follow-up of 43.7
(range 11-77 years).
13 males 10 females
23 patients followed
second round, 4 lost
from initial followup.
16 patients operated
on using this
technique.
Age range 23-67
years.
Defect size range 6 –
16 cm in diameter.
No previous
treatment of soft
tissue defects.
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Results
Limitations
postoperatively from multisystem failure.
of rotation and the
fact that the flap is still
available despite
multiple previous
surgeries.
Follow-up or prior
surgeries.
Follow-up review of data
Healed ulcers without
recurrence.
At initial follow-up in 1993, despite 33% of
patients having had recurrent ulcers and
14.8% having undergone re-advancements,
only 14 % of patients had non-healing
ulcers.
Second follow-up in 1997, 19 live patients
remained, with the deceased 4 patients flap
condition known prior to death and data
included in this follow-up.
7 flaps underwent a re-advancement of
their flap with one requiring a second readvancement. Period of recurrence mean
of 22 months (range 0.5 – 70 months).
Mean age of patients with recurrence was
37.8 with 53.8% being male and 40% being
female.
Recurrence rates of ulcers were 41.4% and
47.8% respectively. 58.6% of flaps therefore
had never broken down since initial
intervention. In 1997, 17 out of the 19 living
patients (89.5%) showed no evidence of
ulceration in the region of their flaps
The V-Y hamstring flap
is justified and the
recurrence rates are
comparable with data
in the literature.
Meticulous education
and prompt follow-up
that ensures surgical
reconstruction
remains the mainstay
of treatment in this
group of patients.
Case Reports
this study, the V-Y
advancement flap was
modified by de-epithelializing
the medial part of the flap
and burying them under the
opposing edge of the wound
or the flap.
All flaps healed well with no
partial of complete loss of the
flap.
All pressure ulcers recovered completely
after the follow-up periods. Complications
developed in 3 patients. One severe
uncontrolled diabetic on steroids for
multiple sclerosis had a severe wound
infection and an abscess. The wound was
resutured, and healed without flap loss.
Another diabetic developed a seroma after
mobilizing too soon. Aspiration and
pressure dressings resulted in wound
Main advantage is the
use of healthy tissues
to obliterate the dead
spaces under the
edges of the wound or
the opposing flap. The
additional layer of
tissue between the
bone and the
superficial tissues
150
Treatment Technical Report
Reference
Type of Study
Hand Surg. 2004;
38(2):94-9.
Follow-up mean 10.5
months (range 5 – 28
months).
Operation time mean
150 minutes (range
90-200 minutes).
Blood loss mean 300
ml (range 150 – 500
ml).
11 patient defects
closed using a
unilateral flap, 5
patients closed with
a bilateral flap.
12 of 14 with
pressure ulcers had
sacrococcygeal, one
had sacrococcygeal
and an ischial, and
one had an ischial
ulcer.
Nine were
ambulatory, and 7
were paraplegic or
bedridden.
10 patients with
large sacral and
trochanteric pressure
Follow-up range 2-10
months.
Defect range 10 – 20
cm.
Age range 15 years –
58 years.
Ulusoy MG, Akan IM,
Sensöz O, Ozdemir R.
Bilateral, extended V-Y
advancement flap. Ann
Plast Surg. 2001;
46(1):5-8.
Sample
Case Reports
Intervention(s)
Outcome Measures &
Length of Follow-up
The usual V-Y flap design is
to have the flaps directly
across from each other either
side of the wound. In this
modification, the flaps were
offset, so one wing was even
with the defect, and the
other wing of that same flap
was farther away from the
edge of the wound, One flap
wing would look like a one
dimensional arm of the Y and
the other would be a very
wide arm of the Y. The two
opposing wide wings of each
flap were then pulled into the
center of the wound and
positioned side by side. The
resulting scar was then more
like an S than a typical V or
Closure of wound and healing
151
Results
Limitations
healing without tissue loss.
One developed a minor superficial skin
slough at the medial suture line.
provides an extra
cushion of soft tissue
putting the suture line
directly over the bony
prominences.
No complications. And complete healing of
the flaps with no recurrence during the
follow-up period.
Since most of the
tension on a V-Y flap
closure is where the
two flaps meet in the
center, by changing
the typical closure
suture line in the
center the tension is
redistributed over a
larger area with less in
one point than in some
earlier V-Y flap closure
lines.
This zig-zag suture line
in the center of the
closure works very
well for large wound
closures.
Treatment Technical Report
Reference
Type of Study
Sample
Wong C-H, Tan B-K,
Song C. The
perforator-sparing
buttock rotation flap
for coverage of
pressure sores. Plast
Reconstr Surg.
2007;119(4):1259-66.
Seven patients with
mean age of 52
(range 33 to 62
years) underwent
reconstruction with
this perforator –
sparing rotation flap
technique.
Mean follow-up was
30 months (range 9 –
51 months).
4 patients needed
muscle to fill the
dead space, and the
muscle flap was
performed
independently of the
skin flap.
Case Reports
Yamamoto Y,
Tsutsumida A,
Murazumi M, Sugihara
T. Long-term outcome
of pressure sores
treated with flap
coverage. Plast
Reconstr Surg.
1997;100(5):1212-7.
53 paraplegic
patients with 45
ischial and 24 sacral
sores between 1990
and 1995 were
treated with flap
coverage.
48 males and 5
females ages ranging
from 17 – 75 years
(mean 50).
Two types of flaps
were used:
Type I
:Fasciocutaneous flap
and Type 2.)
myocutaneous flap.
Average follow-up
was 3 years and 6
months (range 4
months to 5 years
and 4 months),
Case Reports.
Intervention(s)
Outcome Measures &
Length of Follow-up
Results
Limitations
Coverage of wound and healing
of flap without necrosis
All flaps healed without necrosis or
complication. Early breakdown rate was 0 %
and no ulcer recurrence occurred over the
follow-up period.
No recurrence, or very low
incidence of recurrence over the
long term follow-up.
18 of the 45 ischial defects covered with
Type I flaps. 27 with a Type II flap. Total # of
transferred flaps was 48 in 45 sores.
23 of the 24 sacral defects were covered
with a Type I flap. Total # of transferred
flaps was 24 of 24 sores.
The Percent pressure sores free survival
(%PSFS) was calculated by means of the
Kaplan-Meier method and the log rank test.
Because a few patients had multiple sores,
the dada are not independent.
Recurrence was noted in 22 or 45 ischial
sores (48.9%). 27.8 % were from a Type I
flap and a 63% recurrence in the Type II flap.
Recurrence was noted in 5 of 27 sacral sores
(20.8%) with 17.4% being from a Type I flap.
At 36 months the %PSFS was 70% in sacral
sores compared to 50% in ischial sores
Advantages include:
preservation and
inclusion of the
dominant perforator
augments the blood
supply of the
fasciocutaneous flap
and allows the same
amount of
mobilization as the
classic design, The
improved vascularity
renders the flap more
robust and better able
to withstand pressureinduced ischemia, and
in the event of
recurrence, re-rotation
is possible.
Long term follow-up is
essential in order to
lean which flaps are
better suited for
differing types of
reconstructive
surgeries.
straight line.
A review of long term
recurrence after flap surgery
for coverage of defects of
ischial or sacral pressure
sores.
152
Treatment Technical Report
Indirect Evidence
Reference
Type of Study
Sample
Intervention(s)
Akyürek M, Safak T,
Sönmez E, Ozkan O,
Keçik A. A new flap
design: neural-island
flap. Plast Reconstr
Surg.
2004;114(6):1467-77.
92 Wistar rats were
used for three
experiments. 1)
Vascular anatomy of
the femoral
cutaneous nerve was
established. 2) The
role of the cutaneous
nerve in supporting
an acutely elevated
skin flap was
explored, and 3) the
role of the
preliminary surgical
delay procedure to
augment the survival
of the neural island
flap was
investigated.
16 short gracilis
myocutaneous flaps
and 1 short gracilis
muscular flap used to
reconstruct
vulvoperineal,
inguinal, perineal, an
ischial soft-tissue
defects from October
1990 to April 1993.
Between January
2002 and June 2003
10 consecutive
patients, 5 male and
5 female, were
treated with the
modified vastus
lateralis muscle flap
transposition
immediately after
radical debridement
under the clinical
diagnosis of difficult
hip infection
Case Reports
Each step was used to further
enhance the learning curve
for the next of the three
steps. After promising
experiments the Neuralisland flap was used on 4
human patients using a twoweek delay from flap harvest
to flap placement.
Case Reports
Case Reports
Chen SH, Hentz VR,
Wei FC, Chen YR. Short
gracilis myocutaneous
flaps for vulvoperineal
and inguinal
reconstruction. Plast
Reconstr Surg.
1995;95(2):372-7.
Huang K-C, Peng K-T, Li
Y-Y, Tsai Y-H, Huang TJ, Hsu RW-W. Modified
vastus lateralis flap in
treating a difficult hip
infection. J Trauma.
2005;59(3):66571.September;
59(3):665-71
Outcome Measures &
Length of Follow-up
All four neural-island flaps
survived and healed
satisfactorily.
Results
Limitations
Skin flaps survive totally in groups where
the artery and vein were intact, whereas
mean survival rates for the neural island flap
and the neuro-cutaneous flap were 38.2 %
and 44.5% respectively. Results of part III of
the experiment demonstrated significantly
higher survival for the delayed neural island
flap 94.5% compared with the acutely
elevated neural island flap.
Authors conclude that
this report proves for the
first time that a robust
and reliable skin flap can
be created pedicled only
by the intrinsic
vasculature of a
cutaneous nerve, after a
proper surgical delay.
The neural island flap
offers two advantages: a
very narrow pedicle, and
a pedicle without any
restriction to a specific
pivot point.
6 bilateral myocutaneous
flaps were used for
reconstruction post radical
vulvectomy. 5 were used for
reconstruction after
contracture scar removal.
Follow-up between 5 and 27
months
Repair and healing of the flaps.
Immediate complications consisted of
necrosis of the distal third of the cutaneous
portion of the flap in 6 patients. 1 case of
superficial skin necrosis, and wound
infection in 7 patients. Muscular portion of
all flaps survived. A split-thickness skin graft
was used to cover the raw surface of the
remaining tissue.
The 10 patients presented
with various stages of
previous treatments and
chronic hip infections. The
surgery relied heavily on
aggressive debridement of
the wound. Surgical times
ranged from 90 – 240
minutes and blood loss
ranged from 250 – 2200 ml.
depending on the amount of
debridement needed prior to
flap transposition. Flaps
were sized and harvested as
Hip infections in all 10 patients
healed uneventfully.
No need for another soft tissue procedure
was indicated, C-reactive protein returned
to a stable and near-normal level within one
month.
All wounds healed uneventfully in an
average of 13 days (range 10-21 days).
Average hospital stay of 16 days (range 1224 days).
One developed a contralateral iliopsoas
abscess and a secondary septic hip 9 months
after the procedure.
Range of time for hip infection prior to
surgery was from 2 months to 15 months
153
The modified vastus
lateralis flap
transposition has two
primary advantages. 1)
the technique could be a
simple and reliable onestage procedure and 2)
the modified vastus
lateralis flap is extremely
versatile.
Treatment Technical Report
Reference
Type of Study
Sample
All patients had
previously
undergone an
average of 5
procedures, including
debridement,
specific antibioticloaded
polymethylmethacryl
ate beads or interim
endoprosthesis, or
tensor fascia lata
fasciocutaneous flap
transposition. These
procedures did not
control deep joint
infections or heal the
patients wounds.
Average follow-up
period was 17.4
months (range 9-27
months)
Huisinga RL, Houpt P,
Dijkstra R, Storm van
Leeuwen JB. The
distally based sural
artery flap. Ann Plast
Surg. 1998;41(1):5865.
Kim SE, Rhyou IH, Suh
BG, Chung KC. Use of
thoracodorsal artery
Outcome Measures &
Length of Follow-up
Results
Limitations
No statistics were reported. Venous
congestion was reported in one patient,
successfully treated with leaches.
The failed flap turned out to have been
performed on a patient that 5 weeks prior
had patent peripheral arteries. The
circulation was not checked prior to surgery,
and circulation was non-existent at time of
surgery which resulted subsequently in
amputation for inoperable arterial disease.
This patient should not have been operated
on as it turns out.
One partial necrosis was in a diabetic patient
which was angiogramed with an open
peroneal artery.
Persistent infection compromised one flap.
None of the vascularly compromised
patients would have been candidates for
free flap surgery considering the failure rate
of 27%.
Complete healing of defect, harvest site, and
full functionality of all areas of surgery.
The sural artery flap has
the largest arc of rotation
of all flaps for this region.
It does not compromise a
major artery, is simple to
dissect, and has a low
donor morbidity.
was best for each individual
case.
Case Reports
A teardrop shaped sural
artery flap was harvested for
each patient, size and
location of harvest depending
on location and size of
defect.
Twelve flaps survived
completely, two survived
partially, one flap failed.
Case Reports
The thoracodorsal perforator
flaps were taken on each
child under the left of right
Healed injury site, healed
harvest site, and full
functionality of sites.
14 patients with 15
defects of the lower
leg, malleolar, and
heel regions. Seven
patients were
vascularly
compromised
seriously.
Age range was 4 -81
years. Defect sites
were heel (6), lower
leg (2), lateral
malleolus (4), and
one calcaneus and
one dorsum of foot..
Defect size range was
3 X 3 cm to 10 X 14
cm.
Between 2003 and
2004. 4 children (3
male, one female)
Intervention(s)
154
Perforator free flap
(PFF)is not performed
with increasing frequency
Treatment Technical Report
Reference
Type of Study
perforator flap for soft
tissue reconstruction
in children. Ann Plast
Surg. 2006;56(4):4514.
with soft tissue
injuries were treated
with the use of a
thoracodorsal artery
flap graft.
Sample
Knox K, Bitzos I,
Granick M, Datiashvili
R, Benevenia J,
Patterson F.
Immediate
reconstruction of
oncologic
hemipelvectomy
defects. Ann Plast
Surg. 2006;57(2):1849.
Llanos S, Calderón W,
Searle S, Quintas M.
Improvement of the
bipedicled fascial flap
with a cutaneous V
and Y island for
Outcome Measures &
Length of Follow-up
Results
axial. Acoustic doppler
sonography was used to
locate reliable perforators.
Harvested flap sutured in
place after anastomosis of
perforator artery to a viable
artery at transplant site.
Age range was 4 – 13
years.
Defect sites, one
right and one left
foot dorsum, one
right heel, and one
forearm.
Between 1992 and
2002, 11 cases of
radical pelvic
resection and
immediate
reconstruction were
performed.
Intervention(s)
Case Reports
In each case immediate
reconstructive surgery was
necessary due to the size of
the extracted tumor.
In each patient, the wounds
healed sufficiently for hospital
release and ability to resume
daily living.
Size and shape of the flap
varied with patient and
wound
Endpoint goal of most
functionality post healing.
A random fasciocutaneous
flap with bilateral
adipofascial pedicles using
the stepped incision
technique in combination
with the V-Y advancement
Researcher’s personal judgment
of improvements.
None reported
3 males and 8
females with a mean
age of 43.8 years.
Tumor types
consisted of
chondrosarcoma (6),
Paget osteosarcoma
(1), giant cell tumor
(1), malignant fibrous
histiocytoma (1),
squamous cell
carcinoma (1),
synovial sarcoma (1),
and metastatic
uterine carcinoma
(1).
Case series;
reproduction of
Hayashi, A, et al.,
Stepladder V-Y
advance-ment flap
for repair of postero-
4 cases
155
Researchers state that their results did “not
differ from the original work.”
Limitations
in adults for soft tissue
reconstruction.
Many surgeons still
hesitate to perform PFF’s
in children due to
perceived high failure
rates related to the small
diameter of children’s
perforator vessels.
This flap is a viable
alternative to PFF’s for
use in children with soft
tissue defects requiring
surgery.
Reconstructive surgery
following large pelvic
resections used as a
management tool to deal
with complications of a
primary closure, and
It can be implemented
for immediate closure
when primary closure is
not possible, when there
is significant dead space,
when vital pelvic
structure or organs are
exposed,
Primary reconstructive
option remains the
pedicled muscle flap.
Flap survival rates not
provided.
Treatment Technical Report
Reference
Type of Study
coverage of the heel.
Plast Reconstr Surg.
2006;118(1):297-8.
Matsumura H, Makino
K, Watanabe K.
Reconstruction of the
sole and heel and
infancy in childhood
followed up for more
than 10 years. Ann
Plast Surg.
1995;34(5):488-92.
plantar heel ulcers.
Br J Plast Surg 1997;
50:657.
10 patients who
underwent
reconstruction of the
weight-bearing area
of the sole and heel.
Sample
Oberlin C, Azoulay B,
Bhatia A. The
posterolateral
Limitations
Using non weight
bearing tissue for sole
and heel reconstruction is
a feasible option,
especially in children until
adolescence. If
secondary reconstruction
is then required, tissue
and skin from non-weight
bearing areas of the heel
and sole can them be
used once the foot has
reached mature size and
more such tissue is
available.
Analysis demonstrated
the role of compensatory
mechanisms in the
formation of trophic
ulcers.
Proper surgical
management was seen to
assist in equalization of
pressure over the free
flap and minimize risk of
recurrence of the ulcer.
Three criteria
1) Patients injured the weight
bearing area of the sole and
heal before age 10 and initial
reconstruction using tissue
other than the sole and heel
was performed.
2). Follow-up observation
was possible for more than
10 years
3). Follow-up observation
was possible until age 15 or
older.
Healing of initial wound or
defect and weight beating on
the graft as a child.
Secondary reconstruction of the weightbearing area was performed in 7 patients
because of hyperkeratosis and callus
formation with pain using non weight
bearing skin grafts.
Duration between initial and secondary
reconstruction mean was 16 years (range 11
years 1 month to 25 years 1 month) with
three requiring no further surgery.
Case Reports
Roentgenographic
examination was performed
in two planes. Special
attention was directed to
osseous abnormalities such
as osteophytes and
osteomyelitic sequestrate in
the region of the free flap.
Biomechanical examination
of the foot. Gait and its timestrength characteristics were
analyzed. Foot function was
examined, including the
weight bearing pattern on
rolling of the foot, the
vertical force component,
and the maximum pressure
distribution on standing and
walking.
Both studies were performed
before and after treatment.
Reduction of long term trophic
ulcers
Using the surgical techniques developed as
a result of the studies, secondary
development of trophic ulcers decreased
from 37% to 7 %.
Case Reports
The flap taken along the
Achilles tendon region of the
leg with the deep fat intact, is
Complete coverage of wound
with healing of transplant and
donor site.
Flaps survived in all 13 patients.
One skin graft over donor site did not “take”
on one patient, allowed to heal secondarily.
36 patients with 37
free flaps included all
who did not develop
trophic ulcers on
their transferred
flaps.
21 patients (37%)
found to have
trophic ulcers.
From 1988 to 1993
14 flaps were
performed in 13
Results
Case Reports
Mean follow-up was
19 years 5 months
Long term follow-up
results were
analyzed of 57
patients who
underwent
microsurgical
reconstruction of the
plantar surface. Age
range was 13 to 61
years. 77% were
working males.
Divided into two
groups,
Outcome Measures &
Length of Follow-up
principle.
Mean age of 4 years
1 month (range 6
months to 9 years 3
months).
Milanov NO, Adamyan
RT. Functional results
of microsurgical
reconstruction of
plantar defects. Ann
Plast Surg.
1994;32(1):52-6.
Intervention(s)
156
The distally base
posterolateral malleolar
flap is technically easy to
Treatment Technical Report
Reference
Type of Study
malleolar flap of the
ankle: a distally based
sural neurocutaneous
flap--report of 14
cases. Plast Reconstr
Surg. 1995;96(2):400.
patients. 10 mend
and 3 women.
Mean age 54 years
(range 35 to 75
years).
10 patients had heel
injuries the
remaining patients
had skin defects over
the Achilles tendon,
the lateral malleolus,
and the medial
malleolus.
Eight cases of bone
loss, including four
cases of significant
defects in the
calcaneus.
5 patients with
absent lower limb
pulses, one case of
diabetes, one
unspecified
neurologic disorder,
and one paraplegic
Flap mean size was
13.5 cm long by 3 cm
wide (range 9 cm X
2.5 cm to 17 cm X 3
cm)
Donor defect closed
with skin grafts in 11
patients, primarily
closed in 2 patients.
One patient died 3
weeks after bilateral
heel coverage that
had fully healed.
11 fasciocutaneous
flaps were used in 10
patients.
Follow-up of 1 to 3
years.
Orgill DP, Pribaz JJ,
Morris DJ. Local
fasciocutaneous flaps
for olecranon
coverage. Ann Plast
Surg. 1994;32(1):2731.
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
then turned 180 degrees and
layed over the defect of the
heel and lower foot. The
donor site is either closed
primarily, or with split-skin
grafting.
A variety of flaps were
used to cover these
defects including, the
reverse lateral arm flap,
the posterior
interosseous flap, the
ulnar recurrent
Results
Limitations
A recurrent necrosis occurred in a previously
healed graft in a negligent patient in the
second month,
Remaining patients’ postoperative course
was uneventful.
perform, does not
require any fine vascular
dissection, morbidity of
the flap is negligible, with
only minor sensory loss.
Case Reports
None reported
Flap survival with wound closure
157
All flaps survived.
One patient had recurrent ulceration after
being healed for 6 months
One patient with a transient neuropraxia of
the posterior interosseous nerve that
resolved after 2 weeks.
Treatment Technical Report
Reference
Rubin JA, Whetzel TP,
Stevenson TR. The
posterior thigh
fasciocutaneous flap:
vascular anatomy and
clinical application.
Plast Reconstr Surg.
1995;95(7):1228-39.
Type of Study
24 patients
underwent posterior
thigh
fasciocutaneous flaps
between 1989 and
1992
Follow-up ranged
from 2 to 20 months.
Sample
fasciocutaneous flap,
and a proximally based
fasciocutaneous flap.
Case Reports
Safak T, Akyürek M.
The descending branch
of the superficial
circumflex artery
supplying
anteromedial thigh
skin. Plast Reconstr
Surg.
2004;114(5):1118-22.
10 patients with a
mean age of 45
(range 10 to 60
years) between Oct.
1999 and Jan. 2002
underwent defect
flap repairs.
6 male and 4 female.
6 free flaps and 4
local flaps were used
in the 10 patients.
Case Reports
Yildirim S, Taylan G,
Aköz T. Freestyle
perforator-based V-Y
advancement flap for
reconstruction of soft
tissue defects at
various anatomic
26 perforator V-Y
advancement flaps in
24 patients
performed between
July 2004 and
November 2005.
14 female and 10
Case Reports
Intervention(s)
Outcome Measures &
Length of Follow-up
After study of 10 adult
cadavers within 48 hours of
death, and notation of all
perforator vessels supplying
blood to the thigh skin and
the use of dye to locate
vessels and the use of
dissection for photographic
study. this data was used to
help with the location and
lifting of the flaps for the
surgeries performed on the
24 patients in this report.
This flap is designed as
consisting of two paddles in
the groin and anteromedial
thigh regions. Upper paddle
designed traditionally based
on the superficial iliac
circumflex artery. The
second paddle is placed in
the anteromedial thigh
region
Local flaps were used for
reconstruction of scrotal
defect, trochanteric defect,
and lower abdominal skin
and fascia defects,
Free flaps used in
reconstruction for total facial
resurfacing, through and
through cheek defect, and
burn scar contractures and
traumatic defects of the
lower extremity.
Various V-Y advancement
flaps were elevated for
various defects around the
body. Flaps were of no
particular size of location, but
were prepared in proximity
to the defect as best to cover
Results
Limitations
The posterior thigh fasciocutaneous flaps
were based entirely on fasciocutaneous
branches from the first and second profunda
femoris perforating arteries.
A posterior thigh
fascioucutaneous flap
based primarily on the
first and secondary
profunda femoris
perforating arteries
provides versatility and
reusability.
5 early post-operative complications. All
went on to satisfactorily healing with stable
wound coverage but one,
Coverage of the defect and
healing of donor and flap site.
Would coverage and flap
healing
158
One patient developed partial wound
dehiscence related to refractory muscle
spasms resulting in delayed healing and
recurrent ulcer.
All 10 flaps survived completely.
Donor site complications included a seroma
in one case resolved by several syringe
aspirations and wound dehiscence in the
thigh region caused by infection. The latter
required split skin grafting secondarily.
One flap (3.8%) totally necrosed. It was
based on one perforator that was extremely
manipulated to cover the large defect and
was compressed from a hematoma found
under the flap during debridement.
One flap (3.8%) marginally necrosed and
was treated with daily dressings
The groin flap with
anteromedial thigh
extension offers these
advantages. 1). Very easy
and quick to elevate, 2).
Significantly increases
volume of tissue available
for reconstruction. 3).
Two skin paddles that are
independently mobile. 4.)
no need for positional
changes and a two-team
approach is possible. 5).
It can be raised as a
vertical skin island only.
This method is a useful
adjunct to reconstructive
surgical options and can
be used safely by plastic
surgeons at almost all
regions of the body and
without a need for a
Treatment Technical Report
Reference
Type of Study
regions. Ann Plast
Surg. 2007;58(5):5016.
males.
Mean age 48.3 years
(range 22 to 77
years).
Defect size range: 3 X
5 cm to 15 X 20 cm.
15 flaps (57.6%) were
elevated based on
two perforators, 7
flaps (26.9%) were
elevated based on
one perforator, and
the remaining 4
(16.8%) were
elevated based on
three perforators.
Mean follow-up as
14.2 months (range 9
to 21 months).
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
the wound.
159
Results
Limitations
successfully.
Other flaps survived totally (92.4%),
previously described
vascular anatomic
pattern
Treatment Technical Report
Table 13. Pressure Ulcer Management in Individuals Receiving Palliative Care
Direct Evidence
Reference
Type of Study
Sample
Intervention(s)
Abbas SQ.
Diamorphine-Intrasite
dressings for painful
pressure ulcers. J Pain
Symptom Manage.
2004;28(6):532-4.
Retrospective study
17 patients (9 females,
8 males) with a
diagnosis of incurable
malignancy admitted
with Grade 2+ PrUs
over a period of 30
months. Mean age was
68 years (range 47-89).
Dressings were applied with
diamorphine 5-10mg &
Intrasite on a 4x4 dressing.
Dressing changed every 1224 hrs.
Brink P, Smith TF,
Linkewich B. Factors
associated with
pressure ulcers in
palliative home care. J
Palliat Med.
2006;9(6):1369-75.
Retrospective
exploratory study
(March 2002 –
December 2004).
Adult home care clients
(n=561) with terminal
cancer diagnosis
receiving palliative
home care from
Canadian Government
agency, with prognosis
of 6 weeks or >. Sample
of 49% males (n=277)
and 51% females
(n=281) (3 missing).
Average age 69 years.
Health information gathered
on 561 home care clients
March 2002 – Dec 2004.
InterRAI is designed for
palliative care & includes
psych, physical, social &
spiritual well-being. 32
month study.
InterRAI PC comprehensive
assessment form, Cognitive
Performance Scale, ADLHierarchy Scale, MDSDepression Rating Scale, Pain
Scale, Pressure Ulcer, &
prognosis.
Brown G. Long-term
outcomes of fullthickness pressure
ulcers: healing and
mortality. Ostomy
Wound Manage.
2003;49(10):42-50.
Chaplin J. Pressure
sore risk assessment in
palliative care. J Tissue
Viability.
2000;10(1):27-31.
Retrospective
correlational study
for 5 year period
(1998-2002).
Structured review of
computerized medical record
data.
180 day end point from date of
PrU onset.
Tool developed over 18
months
Relationship between nurses
rating of low, medium, high risk
to same nurse rating on risk
assessment tool. Validity &
reliability developed.
Also in Table 4 Pain
Comparative analysis
of professional
judgment of
experienced
palliative care
nurses.
Methodological
study.
Pressure ulcers
Medical records for 74
inpatients (1 female)
who developed FT
pressure ulcers in a VA
Med Center (acute care,
intensive care, long
term care)
Comparative analysis of
professional judgment
of experienced
palliative care nurses
via who did 529 risk
assessments on 291
patients.
Outcome Measures &
Length of Follow-up
Patients routinely recorded the
severity of their pain on a Visual
Analog Scale (VAS) ranging from
0 to 10 (0=asymptomatic) on
admission & after 5 days.
Clinical details were recorded
from their notes. Time over 30
months.
Pressure ulcers
160
Results
Limitations
2 patients died as a result of progressive
illness within a week after application. The
remaining 15 patients showed an
improvement on VAS: 12/17 (70.5%)
improved 4+ points. Mean VAS improved
from 9.4 to 4.6 after treatment (p=<0.02).
Conclusion: diamorphine-Intrasite gel may
be an effective treatment for open PrUs in
palliative care setting & general medicine
units.
PrU prevalence 10.5% (59/549). Stage I
=51.7%, Stage II=33.3%, & Stage III=13.3%.
On chi-square, variables associated with PrU
prevalence 10.5%, with 57.1% Stage I, 33.3%
Stage II, 13.3% Stage III. PrU+ patients were
associated with variables of male gender,
urinary & bowel incontinence, catheter &
ostomy care, new pain site, SOB, inability to
lay flat d/t SOB, insufficient nutritional
intake, age, poor cognition, & poor ADLs. On
logistic regression, male gender, inability to
lay flat d/t SOB, catheter or ostomy care, &
poor ADLs were independent factors
associated with a PrU.
68.9% died within 180 days of 1st detection
of PrU, 1 year mortality rate 78.4%, 2-year
mortality 83.8%. 180-day mortality for acute
care 75%, ICU 66.7%. Average number days
from PrU onset to death 47 days (SD 40).
66% of PrU were sacral, 16% heels. No PrU
healed in those who died within 180 days.
No analysis presented on the validity of
measures. Validity: identified 4 thresholds of
risk: 11 & =low risk, 12-17=medium risk,
18-21=high risk, 22 & =very high risk. Interrater reliability currently being established.
Hunters Hill Marie Curie Centre Risk
Assessment Tool developed which has 7
subscales: sensation, mobility, moisture,
activity in bed, nutrition/weight changes,
skin condition & friction/shear.
More research needs to
be done to address the
possibility of long-term
tolerance, intact skin pain
response, & the right
dose & type of topical
opiods.
Specific focus on clients
with terminal cancer with
prognosis >6 weeks,
limiting generalizability,
as palliative care offered
to all home care clients
regardless of prognosis.
Retrospective use of
cross-sectional data.
Significant limitations,
same nurses used
professional judgment &
also rated with the risk
assessment tool. No
attempt to quantify tool
validity. No statistical
analysis of relationship
between judgment & tool
rating. No reliability
Treatment Technical Report
Reference
Type of Study
Eisenberger A, Zeleznik
J. Pressure ulcer
prevention and
treatment in hospices:
a qualitative analysis. J
Palliat Care.
2003;19(1):9-14.
Qualitative study,
using constant
comparative analysis.
Flock P. Pilot study to
determine the
effectiveness of
diamorphine gel to
control pressure ulcer
pain. J Pain Symptom
Manage.
2003;25(6):547-54.
Randomized, doubleblind, placebocontrolled crossover
pilot trial. Patients
served as own
controls.
Also in Table 4 Pain
Galvin J. An audit of
Quality improvement
Sample
Participants were 18
directors of clinical
services, 9 were MDs &
9 were RNs, & 10 direct
care nurses (mean 18
years total experience
& mean of 4 years in
hospice). None had
advanced practice
training in wound care.
No hospices would give
out family or patient
names so no interviews
done of these people.
Pressure ulcers
Sample=13 patients
from inpatient hospice
unit admitted over 7
months (mean age 77
years, 10 females).
Seven patients
completed study.
Inclusion criteria: Grade
II or III painful PrU, to
be inpatient for 1 or >
weeks. Exclusion
criteria: Grade I or IV
PrU, non-PrU. 12 on
sacral area, 1 heel, 62%
Stage II, mean size
9cm2.
Sample of 542 patients
Intervention(s)
Outcome Measures &
Length of Follow-up
Telephone survey. Saturation
reached after 28 individuals
from 17 hospices were
interviewed.
Telephone survey of questions
based on Medline &
bibliographic review of
literature. Face validity
established, it was pilot-tested
on 2 physicians & 5 nurses with
experience in wound and endof-life care, & family member of
patient who died with a PrU.
Revisions made. Three versions,
1 for directors, 1 for
Direct-care nurses, & 1 for
family.
Random assignment to 1 of 2
treatment sequences: 3 days
of IntraSite gel followed by 3
days of diamorphine gel, or
vice versa. IntraSite gel is
ready-mixed HDG & used as
placebo. Diamorphine gel
(0.1% weight to weight
mixture) was mixed with
IntraSite gel. Gels applied
1x/day & covered with
standard dressing. All
patients had pressure
relieving cushions &
mattresses & encourage to
change positions frequently.
Pre-trial, PrU location, size &
stage were documented.
Medical record audit.
Prior to study entry PrU size,
location, stage was recorded.
Pain assessed before, 1, & 12
hours after gel application by
nursing staff blinded to
treatment sequence. Patients
rated pain as none, mild,
moderate, or over- whelming &
this translated to scores of 0=no
pain to 4=overwhelming. Nurses
checked 1x/day for skin
irritation, pruritus, constipation,
nausea and/or vomiting,
drowsiness, hallucinations,
myoclonus jerking, respiratory
rate. Follow-up was 3 and 6
days.
Two years.
161
Results
Conflicts exist between efforts to prevent &
treat PrUs in patients at end-of-life & can be
painful. Comfort may supersede prevention
& wound care when patients are actively
dying or have conditions causing them to
have a single position of comfort. Complete
ulcer healing was appropriate goal for some
hospice patients. Family caregivers face
additional burdens when PrU develops.
Frequent theme was single position of
comfort. Sharp debridement felt to be too
aggressive. New PrUs are inevitable & don’t
reflect poor care or negligence. Turning,
repositioning, and dressing changes seen as
additional sources of pain, & can forgo these
if they cause too much pain.
Seven patients completed study (5 died, 1
became confused). Pain scores similar
before IntraSite & diamorphine gel
applications. Pain scores improved
significantly 1 (p=0.003) and 12 hours
(p=0.005) after diamorphine gel application
compared with placebo/baseline. Four
patients were pain- free after 1 hour & 3
after 12 hours. No significant difference in
occurrence of side effects between groups
at 1 or 12 hours. No difference in systemic
pain med in the 2 groups. Symptoms of
opioid toxicity similar in both groups.
Average LOS 15 days with 2% (n-11) staying
Limitations
testing of tool. For a
methodological study,
limited evidence/lit
review to support the
tool development. No
info on how many,
education level, age,
experience of any of
nurse raters involved in
the study.
Only US hospices
included. Lacked direct
report from patients &
family caregivers.
Side effects not studied.
Small sample size (but
pilot study). High attrition
rate.
Data verification done by
Treatment Technical Report
Reference
Type of Study
Sample
Intervention(s)
pressure ulcer
incidence in a
palliative care setting.
Int J Palliat Nurs.
2002;8(5):214-21.
P & I study.
Two-year continuous
audit of PrU
incidence on 16-bed
specialist palliative
care unit.
Retrospective check
of chart for why PrU
developed, stage
when first noted, and
action(s) taken.
admitted to palliative
care unit over 2 years
(2000-2001) with mean
age 68 (range 35-90).
Researcher-designed data
collection form placed on
chart within 6 hour of
admission for info on any
pressure damage, size,
appearance, treatment,
Waterlow Score, mattress &
seating surfaces, handling
aids. Info r/t PrU updated
weekly & on discharge.
Documented # of patients
with PrU, # developing in
unit, distribution & severity
of PrU, % of patients
discharged with PrU.
Descriptive study
with retrospective &
prospective
components in
outpatient hospice
agency.
Prospective sample for
prevalence = 8 & for
incidence =19;
retrospective incidence
= 61 over 9 months.
Only adult patients
included. Patients with
a current PrU excluded
from incidence portions
of study.
Hanson D, Langemo
DK, Olson B, Hunter S,
Sauvage TR, Burd C, et
al. The prevalence and
incidence of pressure
ulcers in the hospice
setting: analysis of two
methodologies. Am J
Hosp Palliat Care.
1991;8(5):18-22.
Pressure ulcers
Pressure ulcers
Hatcliffe S, Dawe R.
Clinical audit:
Monitoring pressure
sores in a palliative
care setting. Int J
Palliat Care Nurs.
1996;2(4):182, 4-6.
Prospective point
prevalence survey
study.
All patients included on
palliative care unit on
day of survey over 4
months (same day each
month). N=151. No
patients included >1x.
Outcome Measures &
Length of Follow-up
Waterlow Pressure Sore Risk
Assessment Tool used to assess
risk; Stirling Pressure Sore
Severity Scale (SPSSS) used to
grade pressure damage.
Researchers tracked missing
patients & relevant data.
Phase I Prevalence: all
patients assessed on 1
specified day; Phase II
Prospective Incidence: all
adult patients PrU free
patients screened on
admission & reassessed q
week x 4 week or until death
or discharge if prior to 4 wk.
Retrospective Incidence: all
adult patients PrU free on
admit over 9 month period
were included & charts
audited for PrU incidence
post-admit.
Point prevalence survey same
day q month x 4 mo.
See previous column. Tools
included Braden Scale for
Predicting PrU Risk, a skin
assessment tool, &
demographic data form.
Reported Braden interrater
reliability r=.99 for RNs (all staff
were RNs), & was r=.99 for this
study. NPUAP 1989 PrU stages
used. Demographic data
included sex, age, marital &
ethnic status, smoking history,
steroid therapy, type of bed &
bed overlay used, &
incontinence data.
Waterlow Risk scale used along
with PS stages and
presence/absence of pain on 4
point scale (no pain, mild,
moderate & severe pain)
All 419 patients who
developed a PrU from 2003
through 2005 were treated
All 419 patients who developed
a PrU from 2003 through 2005
were treated until healed or
Pressure ulcers
Masaki F, Riko K, Seiji
H, Shuhei Y, Aya Y.
Evaluation of pressure
Retrospective study,
from 2003 through
2005
Subjects were 202
patients with cancer
and 217 patients
162
Results
Limitations
>50 days. 44% died on unit (n=240). Average
age of patient developing PrU was 69 years
& average LOS 26.5 days. Average percent of
patients admitted with PrU was 26.1%. PrU
incidence was 12%
Retrospective analysis: patients who
developed PrU were older, stayed 12 or >
days, and more of these died than those
without a PrU. 95.3% were “accurately”
assessed as high or very high risk on
Waterlow Tool and 89.2% of PrU were
Grade I or II. Of all PrU, 78.4% were sacral,
and position of tumor as well as comfort &
positioning difficulties considered as most
often responsible. In spite of this
knowledge, superficial PrU still developed.
Prospective prevalence = 13% (1 of 8
patients), prospective incidence = 0% (0 of
19 patients); retrospective incidence =13%.
Stage of PrU were I=6 and II=2; 6 in men & 2
in women. PrU location: sacrum=5 (38.4%),
elbow=4 (30.7%), heel=2 (15.4%) m & ischial
tuberosity & trochanter 1 each. Mean days
of PrU occurrence post-admit was 45.5 (3139), 5 of 8 (62%) of PrU occurred within 2
week of death. 25% each were incontinent
of urine & of feces, 37% were on steroids, 7
of 8 patients had static air matts on bed & 1
had egg crate. Mean age was 68.6 year.
potentially biased unit
staff. Prevalence
calculation not given &
this is confused more by
author summing P & I
rates during discussion to
talk about percent of all
patients with some level
of PrU damage. No data
on how incidence was
calculated. Limited
demographic data
presented.
On Waterlow, 100 of 151 or 66% of patients
at high or very high risk, indicating
vulnerability of sample. Yet, 59% of patients
at high risk & 37% at very high risk had
intact skin. Most PrU were sacral (64%) &
heel (20%). 65% were Stage I-II, 17% Stage III
& 18% Stage IV-V. 52% had no pain, 30% had
mild, 13% moderate & 5% severe pain. PU
prevalence varied from 16-28% & incidence
3-9%. Averages of 30% of PrU developed
post-admit.
36% of cancer group patients died & 15% of
non-cancer group. Mean healing time for
cancer group 19 days & those without
Could not factor in effects
of early preventive
interventions &
treatments; Waterlow
Scale not for palliative
population; did not
compare PrU
development with
proximity to death.
Small sample size & done
in semi-urban Midwest
area. Prospective
methodology needs to be
longer than 4 weeks of
follow-up; therefore for
this study the
retrospective incidence
was more accurate.
Retrospective format
limited to accuracy &
completeness of
Treatment Technical Report
Reference
Type of Study
ulcers in 202 patients
with cancer -- do
patients with cancer
tend to develop
pressure ulcers? Once
developed, are they
difficult to heal?
Wounds.
2007;19(1):13-9.
McDonald A, Lesage P.
Palliative management
of pressure ulcers and
malignant wounds in
patients with
advanced illness. J
Palliat Med.
2006;9(2):285-95.
Munter KC, Beele H,
Russell L, Crespi A,
Gröchenig E, Basse P,
et al. Effect of a
sustained silverreleasing dressing on
ulcers with delayed
healing: the CONTOP
study. J Wound Care.
2006;15(5):199-206.
Review.
Comprehensive
search of MEDLINE,
CINAHL & Cochrane
Databases. Focus on
overview of general
principles of
palliative
management of PrUs
& malignant wounds.
Comparative open
prospective parallel
& block-randomized
study. Total 18mo
study period.
Intervention(s)
without malignant
disease who developed
a PrU. All were treated.
Patients with cancer
ranged from 3 month –
94 years (mean=66.2),
patients without cancer
were 28-92 years
(mean=68), with NSD.
until healed or patient died
as result of PrU.
N=619
Inclusion: 18 or >, not
pregnant or lactating,
chronic wound with
delayed healing & modhigh exudates
8% were PrUs.
Pilot study to identify
prevalence &
incidence of PrU &
test algorithm for
PrU prevention &
management.
Outcome Measures &
Length of Follow-up
patient died as result of PrU.
Results
Limitations
cancer 18.8 days (NSD). Most PrUs in both
groups were Stage I at 1st discovery; sacrum
was site for 76-77% of PrUs. Patients whose
underlying disease is cancer more likely to
develop PrUs. Stat sig diff on Ohura scale for
patients with & without cancer ( score, 
risk). Incidence of PrU in patients with
cancer has increased over past 3 years.
documentation.
Pressure ulcers
Exclusion: depth
<0.5cm
Note: not all were
PrUs
Also in Table 4 Pain &
Table 9 Dressings
Reifsnyder J, Magee
HS. Development of
pressure ulcers in
patients receiving
home hospice care.
Wounds.
2005;17(4):74-9.
Sample
4 home hospice
programs Oct-Dec 2003.
Excluded LTC residents.
N=980
Pressure ulcers
No search terms given,
no search strategies
given, no dates for search
given, no number of
articles included in
search, unable to
evaluate as any level of
evidence d/t significant
limitations.
Patients Randomized to
either silver foam or LBP &
followed weekly for 4 wks.
At q visit wound assessment
made & dressing chg.
HRQoL at 1st & final visits
done.
Pain measured on 10-point
scale, measured at q dressing
change
LBP included a multitude
of dressings, thus large
sample required to offset
this.
Silver foam group had > in wound area
(58.5% v 33.3%), less maceration, better
exudate management, & faster  in odor
than LBP group.
Endpoints  in ulcer size,
exudates, or change in
wound bed composition,
HRQoL, cost effectiveness
Prevalence rates calculated
from Jan-June 2005 (6
month), demographic data;
Karnofsky/Palliative
Performance Scale (PPS),
Braden Scale scores.
Median rating of pain at dressing changes 
in silver foam than LBP group (p<.0001 week
1, p<.0011 week 2) & in between dressing
changes.
PrU prevalence (period)
163
PrU period prevalence 26.9%. Average
patient 75, average LOS 84 days, mortality
rate 81.2%. PrU incidence 10%. Patients who
developed PrU sig older. Patients who
developed PrU had cancer (50%), CNS
disorder/dementia (18.2%), CVD (13.1%),
etc. Non-cancer patients disproportionately
developed PrU. Patients who developed PrU
Prevalence was
retrospective; incidence
reported and not directly
assessed by researchers
(although agency
pharmacist did reporting)
Treatment Technical Report
Reference
Reifsnyder J,
Hoplamazian LM,
Maxwell TL. Preventing
& treating pressure
ulcers in hospice
patients. Caring.
2004;23(11):30-7.
Type of Study
Sample
Retrospective (6
month review) &
prospective (3
month) study. Did
pre- and post-pilot as
well as baseline
studies of PrU
prevalence &
incidence in home
hospice patients I
Hospice Pharmacia,
October-December
2003. HP serves
approximately 20%
of all US hospice
patients.
Oct – Dec 2003 in 4
hospice sites; 980
hospice home patients.
Average age 75 year.
Cancer was diagnosis
for 62.3% of patients.
Sopata M, Luczak J,
Ciupinska M. Effect of
bacteriological status
on pressure ulcer
healing in patients
with advanced cancer.
J Wound Care.
2002;11(3):107-10.
Prospective,
randomized trial.
34 patients with
advanced cancer (18 F,
16 M) & Stage II-III PrU,
24-88 (mean 59 year)
years old. Inclusion
criteria advanced
cancer & life
expectancy >8 year,
Exclusion criteria poor
general condition, Hgb
<7mmol/l & albumin
<2.5g/dl, use of
corticosteroids
Tippett AW. Wounds
at the end of life.
Wounds.
2005;17(4):91-8.
Cross-sectional &
retrospective records
review. Two studies:
Prevalence study in
2003 (A),
retrospective chart
review in 2004 (B)
Pressure ulcers
Pressure ulcers
Study A: 383 patients in
large suburban hospice
during 2 week period in
2003 of which 2/3 were
nursing home residents.
Study B: Retrospective
med record review of
192 consecutive
patients referred to MD
Intervention(s)
Outcome Measures &
Length of Follow-up
Results
had higher risk on Braden scale & mean
Karnofsky scores significantly lower for
patients with PrU as compared to those
without.
PrU prevalence 14.6% in 6-month
retrospective study; 17.5% baseline; 26.9%
3-month study period. 3-month study PrU
incidence 10%. 50% Stage II. Mortality rate
81.2%; average LOS 84 days (range 1-1123
days) for those who died during study;
median LOS 31 days; average
Karnofsky/Palliative Performance Score 40.
Patients with cancer dx had fewer PrU than
patients without cancer dx (CNS disorders,
dementia). Group with higher PrU
occurrence were those with CVA or
dementia. Distribution of PrU stages similar
in Pre- and Post-pilot studies. Most PrU
Stage II (50%), Stage I=25%, Stage III=12%,
Stage IV=9%.
Retrospective data collected
from PrU logs & med records.
Baseline data collected via
survey form completed by all
primary nurses, prospective
data gathered by structured
phone interview to nurses by
pharmacists. PrU prevalence
audits; LOS; demographics;
diagnosis;
PrU prevalence rates for pre-,
baseline, and post-pilot studies;
incidence for 6-month
retrospective & 3-month postpilot studies.
Randomly allocated to
Lyofoam/polyurethane foam
or Aquagel/HDG dressings &
dressings changed based on
clinical need. Noted efficacy,
treatment times & healing
rates. Study time 8 weeks or
until ulcer healed, and was 3
year study (Jan 1996 – Jan
1999). All patients cared for
at Palliative Care Dept.
Dressings changed according
to clinical need. All patients
treated by 1 of 3 nurses.
Qualitative analysis of 38 PrU &
quantitative bacteriological
studies on 19 PrU at baseline &
3 wks. Study time was 8 weeks
or until ulcer healed. Examined
bacterial growth under 2
occlusive dressings.
No SSD between 2 treatment groups in
efficacy, healing rates & treatment times
Bacteriology identified 92 species, but did
not cause any clinical sign of infection.
Bacteria cultured in every PrU. Types & # of
bacteria did not correlate to PrU stage or
dressing used. 80% aerobic & 20%
anaerobic, most common were Staph,
Enterococcus faecalis & Strep Pyogenes.
Neither the Staph species nor anaerobes
caused any clinical symptoms of infection or
affected efficacy, treatment times, & healing
rates.
Study A: Primary care RNs
reported # of patients who
had a Stage I-IV PrU or other
skin issue over 2-week period
mid-March-early April 2003.
Study B: Structured
retrospective audit of
patients referred to MD
wound consultant over 2 ½
Study A: PrU prevalence rate
over 2 wks.
Study B: characteristics of
patients with wounds, type of
wounds, etc.
Study A: PrU prevalence 17.5% or 50% of the
35% of patients who had a “skin issue.”
Study B: Average age 82 years, 2/3 were
female, & 18% Black. Average hospice LOS
82 days, malnutrition present in 71% of
patients, & 2/3 of patients had multiple
wounds (not all PrU). Most common comorbidity dementia (45%), then stroke, PVD,
&DM/cancer. 70% of patients had a PrU &
164
Limitations
Retrospective studies
limited by accuracy &
thoroughness of data
documented. No
statistical analyses
reported for comparing
different time points or
diagnostic categories.
Limited demographic info
on subjects (no gender,
ethnicity/race, etc.). No
specifics given for how P
& I calculated for study.
Use of 4 agencies could
have limited consistency
in data collection &
interpretation.
Small sample size limited
generalizability. Five
patients died after 3rd
week assessment so were
included in analyses.
Retrospective audit
limited by completeness
& accuracy of
documentation. Limited
to patients in one large
metropolitan area, thus
may not be generalizable.
No training of nurse data
collectors, therefore type
Treatment Technical Report
Reference
Type of Study
Sample
Intervention(s)
wound consultant with
mean age 82 years, 67%
female, 18% black,
during 2.5 year periods
2001-2004.
year period, Sept 2001 –
March 2004, for wound
evaluation & treatment.
Outcome Measures &
Length of Follow-up
Pressure ulcers
Walding M, Andrews
C. Preventing and
managing pressure
sores in palliative care.
Prof Nurse.
1995;11(1):33-4, 7-8.
Pre- postintervention study of
PrU prevention
protocol.
20-bed inpatient
hospice unit. Preintervention
sample=115. All inpatients participated.
90% of patients have
malignancy.
Pressure ulcers
PrU Prevention protocol of
risk assessment (Waterlow
Scale), wound assessment
(Morison’s wound-care chart
& Torrance’s grading systems
used), & dressing protocol
(Grade III treatment with
HDC or alginate). Two
teaching sessions done to
orient staff to protocol). Each
nursing team had PrU
resource nurse.
Retrospective pre- intervention
incidence, 3,6, 12, & 24 month
follow-up.
165
Results
Limitations
PrU were 40% of all wounds. Most wounds
on sacrum.” Wounds are predominantly an
end-of-life phenomenon,” & are a significant
problem. “PrUs are almost inevitable in this
frail population. PrUs risk is increased with
poor nutrition, immobility, loss of cognitive
function, and incontinence – all of which are
seen in the end-of-life population.”
“Wounds are strikingly a cardiovascular
phenomenon.” PrUs were mostly Stage II-IV
& necrosis & gangrene highly prevalent.
“Nutritional support…for the majority of
patients was not achievable due to patient
inability, refusal, or lack of availability.”
& number of wounds
with nurse bias may be
inaccurate. Nursing home
patients represented 2/3
of patients. Prevalence
conducted over 2 week
time period rather than 1
day (when nurses able to
see their patients). Some
patients had no follow-up
visit. Prevalence over 2
week may have been
under or over reported.
No attempt to separate
home & NH patients. No
demographic data.
B: problems with missing
data, no data on how far
back each medical record
was reviewed, no followup notes in med record,
almost all were NH
patients, so may be more
reflective of NH sample
than home care or
hospice patients.
Retrospective data in
some areas throughout
study. Unable to
ascertain if charted
treatments were actually
done.
Pre-intervention, retrospective incidence
43% (60% present on admit & 40%
developed on unit). Did 3, 6, 12 & 24 month
incidences after implementing PrU
Prevention protocol. Post-Incidence rates
were: 3 month=28%, 6 month=38%, 12
month=26%, 24 month=21%. Preintervention 40% of PrU developed in
hospital & also at 24 month, but was only
17% at 3 month. Pre- no Risk Assess scores
recorded, & by 6 month post 100% of scores
treated according to protocol & PrU
incidence 21%. Nurses motivated by
protocol & felt PrU were being better
managed.
Treatment Technical Report
Indirect Evidence
Reference
Type of Study
Sample
Intervention(s)
Baharestani MM. The lived
experience of wives caring for
their frail, homebound, elderly
husbands with pressure ulcers
[see comments]. Adv Wound
Care. 1994;7(3):40-2, 4-6, 50
passim.
Spiegelberg’s
phenomenologic
al method qualitative
Semi-structured, face to
face, audio- taped interview
with wives. Field notes
taken. Each wife asked 8
questions. Demographic
info also obtained.
Bale S, Dealey C, Defloor T,
Hopkins A, Worboys F. The
experience of living with a
pressure ulcer. Nurs Times.
2007;103(15):42-3.
Qualitative pilot
study,
Heideggarian
phenomenology
with
interpretative
phenomenologic
al analysis.
Six Caucasian
wife/caregiver
to spouses with Stage
III-IV PrU & bedridden
or chair fast. Mean
age 76.5 year (range
69-82), all had
arthritis, 67% HTN,
50% severe back
problems, 50% taking
tranquilizers. Provided
care to husbands 2-10
year. Husbands mean
age 80.6 year (7388.5). All had fecal
incontinence, 50%
B&B incontinence, 2
had a Foley, 1 had
intermittent caths. No
Stage I or II PrUs, none
receiving >20hr/week
HHA. All were bed or
chair-fast &
dependent in ADLs.
Eight older adults from
4 centres, 3 in England
& 1 in Belgium.
Inclusion criteria
included older adults
with stage 3 or 4 PrU;
exclusion criteria were
spinal cord injury &
inability to provide
informed consent. Age
range 68-101.
Participants had other
co-morbidities.
Also in Table 4 Pain
Unstructured interviews
which acknowledged the
contribution of both the
participant & researcher.
166
Outcome Measures &
Length of Follow-up
180 day end point from date of
ulcer onset. Interviews transcribed
verbatim, data coded, & subjected
to intense analysis. Validity check
on data coding & thematic ID done
by 5 nurses & agreement
ascertained; then for validation, 5
wife caregivers verified thematic
analyses accurately described their
experience.
Results
Limitations
5 major themes & 2 minor recurring
sub-themes. Themes: difficult
caregiving (physical fatigue,
emotionally difficult to see spouse
debilitated, heavy physical safety/care
needs, financial difficulties) frailty of
caregiver CG only health maintenance
was taking prescription meds & seeing
own MD), limited socialization (only
respite when husband hospitalized),
limited social support systems (HHA
viewed as too costly & no adult kids
involved in direct physical care) &
limited care giving knowledge (care
giving learned by experience).
Subthemes were fear regarding the
future & symbolic meaning of the PrU.
None felt financially able to afford 24
hour assistance, NH placement not
desired, future feared. PrU viewed as
normal outcome of being bedbound
but felt “blame” from staff when
husband hospitalized.
Limited to Caucasian
wives, elderly (>60), NY
area. Need replication in
other ethnic groups &
rural areas. Not
followed longitudinally.
Three main themes with
associated sub-themes.
Three main themes of endless pain, a
restricted lifestyle, & coping with the
PrU. Pain was constant & severe
feature & analgesia not always
effective. Pain prevented proper rehab
in some. Cycle of pain, not pain itself
was endless. Severity of pain not
always recognized by MD. Pain  by
repositioning (conflicts with best
evidence on frequent repositioning),
lie still, pain relieving equipment. Pain
was restricting feature with significant
impact on life & feelings re: self.
Worried, depressed feeling
burdensome, inadequate & sense of
powerlessness. Disliked their
dependence on others & change from
former life. Odor was impacting them.
Social life & general activity
Researchers felt design
fitting to multiple
settings. Limited to
older adults and limited
number of participants.
May not be
generalizable
worldwide.
Treatment Technical Report
Reference
Bale S, Tebble N, Price P. A
topical metronidazole gel used
to treat malodorous wounds. Br
J Nurs. 2004;13(11):S4.
Type of Study
Randomized,
double-blind,
placebocontrolled design
Level
Quality: Strong
Krajnik M, Zylicz Z, Finlay I,
Luczak J, van Sorge AA. Potential
uses of topical opioids in
palliative care--report of 6 cases.
Pain. 1999;80(1-2):121-5.
Also in Table 4 Pain
Case review
Sample
N=41. Group 1=20
(Metronidazole),
Group 2=21 (placebo).
Inclusion: malodorous
wounds, able to rate
wound odor,
Exclusion: unable to
rate wound odor
Six cases of patients
treated with topical
opioids. Cutaneous
pain due to tumor
infiltration, skin ulcers
of malignant & nonmalignant origin,
severe oral mucositis,
pain d/t knee
arthrosis, & severe
tenesmoid pain.
Intervention(s)
Outcome Measures &
Length of Follow-up
Wound dressed daily with
gel & secondary dressing.
Assessed at 4 points in time
(baseline, days 1, 3, 7 or
when odor resolved,
whichever was sooner.)
Case review. Patients
received 0.1% morphine gel
Variety of skin ulcers
167
Assessed at 4 points in time
(baseline, days 1, 3, 7 or when
odor resolved, whichever was
sooner.)
Symptom ratings & Semantic
Differential Scale (SDS) ratings
done at days 0, 1, 3 & 7, adverse
events recorded, State-Trait
Anxiety Scale at baseline & days 3
or 7. Demographic data recorded.
Patients, 2 study nurses, &
relatives/carers completed
questionnaires at days 0,1,3,7,
Symptom ratings & Semantic
Differential Scale (SDS), State-Trait
Anxiety Scale all have good validity
& reliability.
Pain relief
Results
restrictions were the worst part.
Impact on s/o & family. PrU also
caused extended hospital stay. Coping
with PrU & the consequences
facilitated thru comparing self with
others “who had it worse.” Acceptance
of situation with some fatalism, &
positive thinking seen as part of
getting on with their lives.
Sample size of 20/group for 90%
power with 95% confidence, assuming
0-10% rate of success in placebo group
& 50-60% success in metronidazole
group.
NSD between groups on age, weight, &
height; on frequency of treatment for
4 classes of wounds.
Was 100% success rate for
metronidazole group, mostly within 3
days & no adverse events; 76% success
rate in placebo group, & NSD between
groups. Patient & nurse odor ratings
sig correlated (p<.001), NSD in mood
state between groups over time.
Patient. A: (89 y/o) with 3x7cm painful
& inflamed subq upper tibial infiltrate.
Pain 4-8 pre- and 0-2 post. Patient B:
(56 y/o) cutaneous pain with sacral &
colostomy infiltration. Pain pre4-10
and post- 1 until last week of life it was
occasionally 6. Patient C: (71 y/o)
severe oral mucositis, pain pre- 10 &
post- 2-4. Patient D: ((71 y/o) painful
necrotic leg ulcers, pain pre- 10 & post4. Patient E: (69 y/o) with cancer of
larynx, pain pre- 9 & post- 2-4. Patient.
F: (62 y/o) vulvar cancer, pain pre- 6 &
post- 2. Opiod receptors are inactive in
non-inflamed tissue. After onset of
inflammation, opioid receptors
become activated within hours.
Morphine & diamorphine appear to do
Limitations
Assessments were
subjective, as no
objective tools
available. Ethical
challenges related to
odor & use of placebo
group.
Decrease in odor in
placebo group may have
been due to frequency
of dressing changes.
Observation periods
were short. Application
of gel to open wound is
difficult, especially with
much exudates, & much
of drug may be flushed
away. Need to identify
how morphine
absorbed through
healthy skin, as is poor
thru intact epidermis,
but when epidermis
removed, bioavailability is 75%. Is
morphine absorbed
systemically rather than
locally?
Treatment Technical Report
Reference
Type of Study
Sample
Intervention(s)
Outcome Measures &
Length of Follow-up
Langemo DK, Melland H, Hanson
D, Olson B, Hunter S. The lived
experience of having a pressure
ulcer: a qualitative analysis. Adv
Skin Wound Care.
2000;13(5):225-35.
Spiegelberg’s
phenomenologic
al method –
descriptive,
qualitative
Non-probability,
purposive sample of 8
respondents, 4 with
PrU & 4 with previous
PrU (Stage II-IV). Four
had SCI & 5 had
surgical flap
reconstruction; 2 had
MS, 1 was bipolar,
alcoholic, & 1
degenerative
neuromuscular
disorder. Males=7,
female=1, mean age
35.7 year, range 27-52
year. 6 of 8 had
multiple PrU, all 4
current patients with
PrU were Stage IV
N=46
50% male, 50% female
Inclusion: heavily
exudating leg ulcer
Exclusion: sensitivity
to GFD-N, history poor
adherence, arterial
ulcer, required wound
filler on enrollment
Unstructured, face to face,
audio- taped interviews.
Field notes taken. Each
person asked to respond to
“Please describe your
experience of having a PrU.
Share all the thoughts,
perceptions, & feelings you
can recall until you have no
more to say about this
experience.” Used relevant
probes to elicit additional
data. Demographic info also
obtained.
Interviews transcribed verbatim,
accuracy verified. 3 researchers
ensured content validity. Colaizzi’s
content analysis established via
reading transcriptions, extracting
significant statements & phrases
directly r/t lived experience,
meaning formulated from
significant statements & phrases,
formulated meanings organized
into clusters of themes, &
researchers integrated results into
exhaustive description of the lived
experience.
Baseline data, pain level,
peri-ulcer skin info
collected. Wound cleaned,
debrided & measured.
Subjects’ treatment with
non-adhesive gelling foam
dressing & compression for
28 days & pain assessed. At
least weekly clinic visits.
Outcome measure=pain intensity
rated on VAS 10-point scale.
Also in Table 4 Pain
Vanscheidt W, Münter KC,
Klövekorn W, Vin F, Gauthier J,
Ukat A. A prospective study on
the use of a non-adhesive gelling
foam dressing on exuding legs
ulcers. J Wound Care.
2007;16(6):261-5.
Also in Table 4 Pain
Pre- Post,
Prospective open
label
comparative
study.
168
Length of follow-up 28 days or
withdrawal from study, whichever
came 1st.
Primary endpoint safety, 2nd
endpoint measures of dressing
performance, exudates
management, ease of use &
pain/comfort.
Results
equally well.
7 themes emerged: perceived etiology
of PrU, life impact & changes (physical,
financial & social), psycho-spiritual
impact (body image changes, struggle
with stereotypes, desire/struggle for
control & independence, spiritual
impact), extreme painfulness with PrU
(pain Intensity & duration, analgesic
use), need for knowledge &
understanding (knowledge of
prevention, physiologic processes &
lack of knowledge), need for & effect
of numerous stressful treatment (selfcare, treatment regimens & multiple
surgeries, complications, length of
healing time), & grieving process
(denial, depression, anger, bargaining,
acceptance).
Mean pain VAS intensity rating  >50%
for 1st clinic dressing change compared
to pre-study (4.7 v 23, p<.001) & on
removal (3.9 v 1.7, p<.001). Periwound skin condition better for 31%
(p=0.006). GFD-N dressing associated
with SSD  in ulcer pain with dressing
in place & during removal. Of 46
subjects, 11% healed the ulcer & 78%
improved in 4 or < wks.
GFD-N was safe, effective &
convenient for wound healing,
exudates management, pain/comfort
& ease of use.
Limitations
Limited to Caucasians,
young or middle age, in
Midwest area of US.
Need replication in
other ethnic groups &
urban areas. Not
followed longitudinally.
Subjects used as own
control, no RCT, no true
control group.
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