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 1 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. 2 Treatment Technical Report 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. 3 Treatment Technical Report • 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. 4 Treatment Technical Report 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 5 Treatment Technical Report 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, 6 Treatment Technical Report 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 7 Treatment Technical Report 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. 8 Treatment Technical Report 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 9 Treatment Technical Report 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 10 Treatment Technical Report 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 11 Treatment Technical Report 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. 12 Treatment Technical Report 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 13 Treatment Technical Report 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 14 Treatment Technical Report 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. 15 Treatment Technical Report 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. 16 Treatment Technical Report 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, 17 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. 18 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. 19 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. 20 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. 21 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 22 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 23 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) 24 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 25 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 26 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 27 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. 28 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 29 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. 30 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. 31 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 (p0.0167) in debriding at all 3 time points -Reduction in area of nonviable tissue covering wounds over time was significantly greater (p0.0167) for papain-urea at all 3 evaluations -Visual scores showed that granulation was significantly (p0.0167) 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 (p0.0001) -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 ↑ (p0.0005) & 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 (p0.005) -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 (p0.005) -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 (p0.05) DM (P0.05) (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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