Comparative Effectiveness Review Number 127 Chronic Venous Ulcers: A Comparative Effectiveness Review of Treatment Modalities Comparative Effectiveness Review Number 127 Chronic Venous Ulcers: A Comparative Effectiveness Review of Treatment Modalities Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 540 Gaither Road Rockville, MD 20850 www.ahrq.gov Contract No. 290-2007-10061-I Prepared by: Johns Hopkins University Evidence-based Practice Center Baltimore, MD Investigators Jonathan Zenilman, M.D. M. Frances Valle, D.N.P., M.S. Mahmoud B. Malas, M.D., M.H.S. Nisa Maruthur, M.D., M.H.S. Umair Qazi, M.P.H. Yong Suh, M.B.A., M.Sc. Lisa M. Wilson, Sc.M. Elisabeth B. Haberl, B.A. Eric B. Bass, M.D., M.P.H. Gerald Lazarus, M.D. AHRQ Publication No. 13(14)-EHC121-EF December 2013 Erratum January 2014 This report is based on research conducted by the Johns Hopkins University Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2007-10061-I). 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. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services. The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—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. Anyone who makes 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. This document is in the public domain and may be used and reprinted without permission except those copyrighted materials that are clearly noted in the document. Further reproduction of those copyrighted materials is prohibited without the specific permission of copyright holders. Persons using assistive technology may not be able to fully access information in this report. For assistance contact [email protected]. None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report. Suggested citation: Zenilman J, Valle MF, Malas MB, Maruthur N, Qazi U, Suh Y, Wilson LM, Haberl EB, Bass EB, Lazarus G. Chronic Venous Ulcers: A Comparative Effectiveness Review of Treatment Modalities. Comparative Effectiveness Review No. 127. (Prepared by Johns Hopkins Evidence-based Practice Center under Contract No. 290-2007-10061-I.) AHRQ Publication No. 13(14)-EHC121-EF. Rockville, MD: Agency for Healthcare Research and Quality. December 2013. Erratum January 2014. www.effectivehealthcare.ahrq.gov/reports/ final.cfm. Erratum In the original version of this report, Tables A and 1 incorrectly listed “Cryopreserved human skin allograft (TheraSkin®)” as an acellular biological dressing. TheraSkin should be listed as a cellular biological dressing. ii Preface The Agency for Healthcare Research and Quality (AHRQ), through its Evidence-based Practice Centers (EPCs), sponsors the development of systematic reviews to assist public- and private-sector organizations in their efforts to improve the quality of health care in the United States. These reviews provide comprehensive, science-based information on common, costly medical conditions, and new health care technologies and strategies. Systematic reviews are the building blocks underlying evidence-based practice; they focus attention on the strength and limits of evidence from research studies about the effectiveness and safety of a clinical intervention. In the context of developing recommendations for practice, systematic reviews can help clarify whether assertions about the value of the intervention are based on strong evidence from clinical studies. For more information about AHRQ EPC systematic reviews, see www.effectivehealthcare.ahrq.gov/reference/purpose.cfm. AHRQ expects that these systematic reviews will be helpful to health plans, providers, purchasers, government programs, and the health care system as a whole. Transparency and stakeholder input are essential to the Effective Health Care Program. Please visit the Web site (www.effectivehealthcare.ahrq.gov) to see draft research questions and reports or to join an email list to learn about new program products and opportunities for input. We welcome comments on this systematic review. They may be sent by mail to the Task Order Officer named below at: Agency for Healthcare Research and Quality, 540 Gaither Road, Rockville, MD 20850, or by email to [email protected]. Richard G. Kronick, Ph.D. Jean Slutsky, P.A., M.S.P.H. Director Director, Center for Outcomes and Evidence Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality Stephanie Chang, M.D., M.P.H. Christine Chang, M.D., M.P.H. Director Task Order Officer Evidence-based Practice Program Center for Outcomes and Evidence Center for Outcomes and Evidence Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality iii Acknowledgments The Evidence-based Practice Center wish to thank the Key Informants, the Technical Expert Panel, foreign language contributors Sarah Burke, Maria Casamassima, Saskia Nahrgang, Barbara Summerer, and Natalia Vlassova, reviewers Darcy Ward, Minxuan Huang, Alec Mkwamba, Ugo Ottih, and Adefemi Taiwo, and medical writer Eric Vohr. Key Informants In designing the study questions, the EPC consulted several Key Informants who represent the end-users of research. The EPC sought the Key Informant input on the priority areas for research and synthesis. Key Informants are not involved in the analysis of the evidence or the writing of the report. Therefore, in the end, study questions, design, methodological approaches, and/or conclusions do not necessarily represent the views of individual Key Informants. Key Informants must disclose any financial conflicts of interest greater than $10,000 and any other relevant business or professional conflicts of interest. Because of their role as end-users, individuals with potential conflicts may be retained. The TOO and the EPC work to balance, manage, or mitigate any conflicts of interest. The list of Key Informants who participated in developing this report follows: Adrian Barbul, M.D. Robert Kirsner, M.D. Hackensack University Medical Center University of Miami Hackensack, NJ Miami, FL Laura Bolton, Ph.D. David Margolis, M.D., Ph.D. Robert Wood Johnson University Medical University of Pennsylvania School Philadelphia, PA New Brunswick, NJ Jeff Richardson, M.D. William B. Greenough III, M.D. Johns Hopkins University Johns Hopkins University Baltimore, MD Baltimore, MD William Tiller Diane Krasner, R.N., Ph.D. Montgomery, AL Rest Haven-York Rehabilitation and Nursing Center York, PA iv Technical Expert Panel In designing the study questions and methodology at the outset of this report, the EPC consulted several technical and content experts. Broad expertise and perspectives were sought. Divergent and conflicted opinions are common and perceived as healthy scientific discourse that results in a thoughtful, relevant systematic review. Therefore, in the end, study questions, design, methodologic approaches, and/or conclusions do not necessarily represent the views of individual technical and content experts. Technical Experts must disclose any financial conflicts of interest greater than $10,000 and any other relevant business or professional conflicts of interest. Because of their unique clinical or content expertise, individuals with potential conflicts may be retained. The TOO and the EPC work to balance, manage, or mitigate any potential conflicts of interest identified. The list of Technical Experts who participated in developing this report follows: Laura Bolton, Ph.D. Robert Kirsner, M.D. Robert Wood Johnson University Medical University of Miami School Miami, FL New Brunswick, NJ David Margolis, M.D., Ph.D. Ellie J.C. Goldstein, M.D. University of Pennsylvania David Geffen School of Medicine at UCLA Philadelphia, PA Los Angeles, CA Penny Mohr, M.A. William B. Greenough III, M.D. Center for Medical Technology Policy Johns Hopkins University Baltimore, MD Baltimore, MD Jeff Richardson, M.D. Diane Krasner, R.N., Ph.D. Johns Hopkins University Rest Haven-York Rehabilitation and Baltimore, MD Nursing Center York, PA Jeffrey M. Robbins, D.P.M. Veterans Health Administration Central Office Washington, DC and Cleveland, OH v Peer Reviewers Prior to publication of the final evidence report, EPCs sought input from independent Peer Reviewers without financial conflicts of interest. However, the conclusions and synthesis of the scientific literature presented in this report does not necessarily represent the views of individual reviewers. Peer Reviewers must disclose any financial