Management of Open Fractures Recent Advances and Practices Andrew N. Pollak, MD The James Lawrence Kernan Professor and Chairman Head Division of Orthopaedic Traumatology Department of Orthopaedics University of Maryland School of Medicine Chief of Orthopaedics and Associate Director of Trauma R Adams Cowley Shock Trauma Center Chief of Orthopaedics University of Maryland Medical System Management of Open Fractures • What’s new in initial management of open fractures? • What role does timing of treatment play in the management of open fractures? • What are the relative advantages and disadvantages of amputation versus limb salvage in the treatment of high-energy lower extremity trauma Initial Management of Open Fractures • Initial Hemorrhage Control • Use of antibiotics • Techniques of debridement – Lavage • Nailing versus external fixation Initial Hemorrhage Control • Classic Teaching – Direct pressure controls most extremity hemorrhage – Look for other sources of hemorrhage if patient presents with hypotension Tourniquet summary • Early application of tourniquets for treatment of extremity hemorrhage – before onset of shock – saves lives • Complications with liberal use of tourniquets are rare • Consider control of extremity bleeding BEFORE airway management when massive hemorrhage is evident Use of Antibiotics in Open Fractures • Antibiotics for preventing infection in open limb fractures – Gosselin, Roberts, Gillespie - Cochrane Database Syst Rev. 2004;(1):CD003764. – Data from 913 participants in seven studies – Antibiotics reduce the incidence of early infections in open fractures of the limbs. Further placebo controlled randomised trials are unlikely to be justified Antibiotics - Recommendations • Cultures not helpful in directing therapy – Pre or post-debridement • Current recommendations – First generation cephalosporin for all open fractures as soon as feasible after diagnosis – Stop 24 hours after initial debridement – Repeat peri-operatively after each debridement for 24 hours Antibiotics - Recommendations • High-energy open fractures – Add gram negative coverage for Type III open fractures (particularly those with gross contamination) • No evidence linking this to decreased infection rate • May increase resistant strain risk – Add penicillin or ampicillin for anaerobic coverage for farm injuries Techniques of debridement What are the optimal Irrigation Techniques and Fluids> • RCT 458 open fxs/400 pts – castillo soap vs saline/bacitracin – trend towards reduced infection risk and wound healing problems with soap – Anglen JO – JBJS 2005 • Fluid Lavage of Open Wounds (FLOW) pilot – no significant findings – trends favor low pressure and soap • FLOW pivotal trial underway Adjunctive Treatments • Local antibiotic delivery, i.e. Bead Pouch DeCoster TA, Bozorgnia S. Surgical Techniques: Antibiotic Bead. J Am Acad Orthop Surg 2008;16:674-678 • Negative Pressure Wound Therapy (NPWT) Courtesy Josh Wenke, PhD &CPT Dan Stinner, MD Methods • A complex musculoskeletal wound was created on the hindlimb of 20 goats • Contaminated with S. aureus (lux) bacteria Courtesy Josh Wenke, PhD &CPT Dan Stinner, MD Methods Courtesy Josh Wenke, PhD &CPT Dan Stinner, MD Methods • Irrigation and Debridement at 6 hours post contamination – Imaging done pre and post • Two different groups – Control group: Antibiotic bead pouch (ABP) – Experimental group: NPWT + antibiotic PMMA beads (augmented NPWT) Courtesy Josh Wenke, PhD &CPT Dan Stinner, MD Methods • Vancomycin – (2g/40g bag cement) • 16 beads per goat Courtesy Josh Wenke, PhD &CPT Dan Stinner, MD Methods • Antibiotic levels measured in effluent – 6, 12, 24, 36, 42 hours post treatment • Final imaging performed at 48 hours Results Courtesy Josh Wenke, PhD &CPT Dan Stinner, MD Results Courtesy Josh Wenke, PhD &CPT Dan Stinner, MD Results 6 hours 6 hours Courtesy Josh Wenke, PhD &CPT Dan Stinner, MD Results 48 hours 48 hours Courtesy Josh Wenke, PhD &CPT Dan Stinner, MD Results 6 hours 48 hours 6 hours Courtesy Josh Wenke, PhD &CPT Dan Stinner, MD 48 hours Results Courtesy Josh Wenke, PhD &CPT Dan Stinner, MD Perspective Courtesy Josh Wenke, PhD &CPT Dan Stinner, MD Perspective Ladder of Bacteria Reduction Courtesy Josh Wenke, PhD &CPT Dan Stinner, MD Perspective Ladder of Bacteria Reduction ABP aNPWT NPWT +Silver (Unpublished data) NPWT Courtesy Josh Wenke, PhD &CPT Dan Stinner, MD Courtesy Josh Wenke, PhD &CPT Dan Stinner, MD Ladder of Bacteria Reduction Antibiotic Sponge w/ NPWT Antibiotic Sponge Pouch Antibiotic Bead Pouch Augmented NPWT (Abx Beads w/ NPWT) NPWT w/ Silver Dressing Standard NPWT Wet-to-Dry Dressings 400% 300% 200% Percent of Baseline 100% 0% Closure/Coverage of Open Fractures • Soft tissue coverage as soon as technically possible for IIIA injuries – Return for repeat debridement if deemed appropriate Closure/Coverage of Open Fractures • Flap Coverage within 7 days of injury if possible for IIIB injuries – May be determined by patient factors Immediate nailing of open tibia fractures SPRINT Study – JBJS 2008 35/400 = 9% infection rate Military rates higher – 14.9% Lacap & Frisch, 40% Mody, et al. J Trauma 2009 Majority of civilian open fractures in 2013 can be safely managed with protocol of early antibiotics, debridement, internal fixation including reamed nailing Indications for definitive external fixation • Severe contamination where thorough debridement not certain • Complex fracture pattern where transport may be desirable • Host factors – Diabetes – Hepatic insufficiency Timing of Debridement basic science argument • Substance of the argument – Friedrich studies – Bacterial debridement easier prior to 2 hours • Less adherence, less biofilm formation – More difficult after 6 hours – Devitalized bone likely presents an idealized binding surface – In vitro studies have demonstrated time-dependent efficacy of bacterial removal procedures (debridement) – Applies primarily to availability of idealized binding surfaces Timing of Debridement clinical argument • Schenker, et al. – systematic review of the literature – 16 studies – 3539 open fractures met inclusion criteria – No significant difference between open fractures treated early or late regardless of time threshold used, open fracture severity or depth of infection – No clinical support in literature for “6 hour rule” Limb Salvage versus Amputation • Make sure all questions are covered The LEAP Study • Prospective, Longitudinal, Observational, Outcomes Study • 8 - Level 1 American Trauma Centers – Accepted Principles of Fracture Care Protocol – Attending surgeons direct all evaluations, decisions and extremity treatment • 656 eligible patients , ages 16 -69 – 55 exclusions • 36 – refusal to participate • 13 – in-hospital death • 6 – administrative failure to enroll • 601 Patients LEAP Function at 2 Years Total N=464 Amps N=133 ALL Recons N=331 IIIB N=136 FA/Pilon N=94 % FWB 92.8 91.1 93.4 92.3 93 % RTW 51 53 49.4 48.4 55.7 Mean VAS 27 25 27.8 28.4 30.1 Mean SIP 12 12.6 11.8 13.2 11.8 % SIP ≥ 10 42.2 43.9 41.5 47.4 40.4 Sensation at 24 months for pts with initial impaired sensation Normal % Impaired Absent Amputated 100 80 60 40 20 0 Group III Salvage Controls LEAP Summary • Limb salvage scoring systems are not valuable in determining need to amputate or potential to salvage • Outcomes are equally poor for limb salvage and amputation long-term – METALS did NOT disprove this LEAP Summary • Amputation costs MORE than limb salvage long-term – Primarily because of prosthetic costs • Absence of plantar sensation on initial examination predicts NOTHING!!! LEAP Summary • Approximately 50% of LEAP patients who were gainfully employed prior to their injury had returned to work at 2 years post-injury • Absence of plantar sensation on initial examination predicts NOTHING!!! • Infection predicts poorer clinical outcome The Major Extremity Trauma Research Consortium METRC Extremity War Injuries - Background • Casualty volume from Operation Iraqi Freedom (OIF)/Operation Enduring Freedom (OEF) has been the highest since Vietnam. • Approaching 50,000 military personnel have sustained combat related injuries. • Military surgeons have had to provide care to multinational force members, civilian contractors, Iraqi civilians and suspected insurgents, in addition to our own personnel. Orthopaedic Military – Civilian Patient Care • What the military surgeons learn during wartime, the civilian surgeons try to perfect during peacetime • Overtime, civilian trauma patients receive the greatest benefit from our wartime advances – – – – – – – Resuscitation Hand surgery Vascular Surgery Trauma Center Concepts Wound Care Amputations Rehabilitation Orthopaedic Research Funding in Defense Appropriations Bills (millions) (President’s request each year = “0”) Congressional Appropriations 140 120 Congressional Appropriations 100 80 60 40 20 0 FY 06 FY 07 FY 08 FY 09 FY 10 FY 11 FY 12 FY 13 Consortium Approach • Develop a Research Agenda • Establish a centralized Data Coordinating Center • Take advantage of experts in the design and running clinical trials • Pay attention to efficiency • Collect data uniformly across studies • Leverage resources METRC ORGANIZATIONAL CHART Potential Partners Gov’t Steering Committee NIH Industry DSMB Executive Committee Liaisons METRC Steering Committee AFIRM VA Coordinating Center Satellite Centers CORE CORE CORE CORE Other Committees CORE CORE CORE CORE CORE CORE CORE CORE CORE CORE CORE CORE CORE Publications Committee CORE Protocol Protocol Committee Protocol Committee Protocol Committee Protocol Committee Committee Adjudication Committee CORE CORE CORE CORE CORE CORE Data Standards Committee METRC CLINICAL SITES • 26 Core Sites – 22 Civilian Centers – 4 Military Centers • • • • WRNMMC SAMMC NMCP NMCSD • 30 Satellite Centers REGISTRY DATA The power of numbers . . . Annual Number at the 24 Core Civilian Centers LEF / Type III UEF / Type III Pelvic Fxs Complex Foot Amputations 5,628 / 775 1,330 / 170 1,900 956 294 METRC Studies: Infection RCTs to Compare Existing Txs and Evaluate Promising New Approaches FIXIT Trial: Comparing Nails vs. Ring Fixation for Type III B Tibias POvIV Trial: IV or PO antibiotic therapies for the treatment of deep infections APS Trial: Investigating the use of an Antibacterial Plate Sleeve (APS) in reducing the rate of surgical site infections after operative treatment of high-energy fxs Oxygen Trial: Effects of high dose perioperative oxygen on the rate of surgical site infection METRC Studies: Infection Developing a Better Understanding of Wound Flora BIOBURDEN STUDY: A prospective observational study to characterize modern wound bioburden at time of closure and correlate with incidence of downstream infections - we will also compare PCR (Ibis 5000) vs. standard culture Results will drive development of RCTs employing local/topical anti-microbial wound therapy Status of METRC Studies 6 Studies are enrolling patients 3 Studies recently implemented 4 studies in regulatory review A total of 723 patients have been enrolled METRC Leader Board #1 #2 #3 #4 #5 #6 #7 #8 #9 #10 CMC UMD HOU VMC UMS WFU RYD MET MIN ORL Total ALL Sites 131 100 91 55 34 33 29 26 25 25 723 Studies Underway at Shock Trauma: • FIXIT • BIOBURDEN • OUTLET • TCCS • PAIN •PACS ON-GOING CHALLENGES • Efficiency of running large trials & working through regulatory process • Methodological Challenges (many): – Strong surgeon preferences – Patient recruitment and follow-up • Cannot support further studies that will compete for patients needed in ongoing studies . . . e.g. severe tibia fractures • Satellite centers are critical to our success !
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