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Skin Substitutes for Treating Chronic Wounds

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Skin Substitutes for Treating Chronic Wounds • Technology Assessment Skin Substitutes for Treating Chronic Wounds Technology Assessment Program Final Report December 18, 2012 Prepared for: Agency for Healthcare Research and Quality 540 Gaither Road Rockville, Maryland 20850 Skin Substitutes for Treating Chronic Wounds Technology Assessment Report Project ID: HCPR0610 December 18, 2012 ECRI Institute EPC David L. Snyder, Ph.D. Nancy Sullivan, B.A. Karen M. Schoelles, M.D., S.M., F.A.C.P. This report is based on research conducted by the ECRI Institute Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract Number: HHSA 290-2007-10063). The findings and conclusions in this document are those of the author(s) who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. No statement in this article should be construed as an official position of the Agency for Healthcare Research and Quality or of the U.S. Department of Health and Human Services. The information in this report is intended to help health care decision-makers; patients and clinicians, health system leaders, and policymakers, make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients. This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied. None of the investigators has any affiliations or financial involvement related to the material presented in this report. ii Peer Reviewers We wish to acknowledge individuals listed below for their review of this report. This report has been reviewed in draft form by individuals chosen for their expertise and diverse perspectives. The purpose of the review was to provide candid, objective, and critical comments for consideration by the EPC in preparation of the final report. Synthesis of the scientific literature presented here does not necessarily represent the views of individual reviewers. Vickie R. Driver, M.S., D.P.M., F.A.C.F.A.S. Associate Professor of Surgery Director, Clinical Research Limb Preservation, Wound Healing Director, Research Fellowship and International Scholars Program Boston University Medical Campus and Boston University School of Medicine Boston, Massachusetts Mary E. Ritchey, Ph.D. Associate Division Director FDA/CDRH/Office of Surveillance and Biometrics Food and Drug Administration Silver Spring, MD iii Skin Substitute Products Considered in This Report: Products derived from human donor tissue, minimally processed: AlloDerm Regenerative Tissue Matrix Allopatch HD™ Alloskin™ Cymetra® Micronized AlloDerm Dermacell® and Arthroflex® Flex HD® GammaGraft® Graftjacket® Regenerative Tissue Matrix Matrix HD™ Memoderm™ Puros® Dermis Repliform® TheraSkin® Products derived from living human and/or animal tissues and cells: Apligraf®/Graftskin Dermagraft® Acellular animal-derived products: ACell UBM Hydrated Wound Dressing ACell UBM Lyophilized Wound Dressing Aongen™ Collagen Matrix Atlas Wound Matrix Avagen Wound Dressing Collagen Sponge (Innocoll) Collagen Wound Dressing (Oasis Research) Collaguard® CollaSorb™ CollaWound™ Collexa® Collieva® Coreleader Colla-Pad Dermadapt™ Wound Dressing DressSkin E-Z Derm EndoForm Dermal Template™ Excellagen FortaDerm™ Wound Dressing HA Absorbent Wound Dressing Helicoll Integra™/Bilayer Matrix Wound Dressing Integra™ Flowable Wound Matrix LTM Wound Dressing iv MatriStem MatriStem® Wound Matrix Matrix Collagen Wound Dressing Medline Collagen Wound Dressing Oasis® Primatrix™ Primatrix™ Dermal Repair Scaffold SIS Wound Dressing II SS Matrix™ Stimulen™ Collagen TheraForm™ Standard/Sheet Unite® Biomatrix Unite™ Biomatrix Biosynthetic products: Hyalomatrix® (Laserskin®) Hyalomatrix® Jaloskin® Suprathel® Talymed® v Contents Executive Summary .............................................................................................................. ES-1 Background ....................................................................................................................... ES-1 Methods of the Review ...................................................................................................... ES-3 Evidence for Skin Substitutes ............................................................................................ ES-7 Key Question 1: What are the U.S. Food and Drug Administration (FDA)-regulated skin substitutes that fall under each of the following pathways: PMA, 510(k), PHS 361[21 CFR 1270 & 1271]? ....................................................................................... ES-7 Key Question 2: For patients with chronic wounds (pressure ulcers, diabetic foot ulcers, venous leg ulcers, or arterial leg ulcers), are skin substitutes more effective than other wound care options (usual or standard care, or usual or standard care plus synthetic dressings, growth factors, skin grafts, or other treatments used as a comparison) in promoting wound healing for the following outcome measures: ....................................... ES-20 Key Question 3: What type and frequency of adverse events are reported in the clinical literature for each of the FDA-regulated skin substitute products? .................................... ES-22 Conclusion ...................................................................................................................... ES-22 Abbreviations and Acronyms ........................................................................................... ES-24 Background .................................................................................................................................1 Normal Healthy Skin ............................................................................................................... 1 Chronic Wounds ...................................................................................................................... 2 Diabetic Foot Ulcers ............................................................................................................ 2 Pressure Ulcers .................................................................................................................... 3 Vascular Leg Ulcers ............................................................................................................. 3 Phases of Normal Wound Healing ........................................................................................... 4 Skin Substitutes ....................................................................................................................... 6 Usual Care for Chronic Wounds .............................................................................................. 6 Skin Grafts ........................................................................................................................... 8 Wound Dressings ................................................................................................................. 8 Growth Factors .................................................................................................................... 9 U.S. Food and Drug Administration Regulations Governing Skin Substitute Products ........... 10 Human Cells, Tissues, and Cellular and Tissue-Based Products ......................................... 10 Premarket Approval ........................................................................................................... 10 510(k) Submissions ............................................................................................................ 11 Humanitarian Device Exemption ....................................................................................... 11 Methods .................................................................................................................................... 13 Key Questions ....................................................................................................................... 14 vi Analytic Framework .............................................................................................................. 14 Inclusion Criteria ................................................................................................................... 17 Population .......................................................................................................................... 17 Intervention........................................................................................................................ 17 Study Design ..................................................................................................................... 17 Outcomes ........................................................................................................................... 17 Publication Type ................................................................................................................ 18 Search Strategy .....................................................................................................................
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