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Chronic Venous Ulcers: A Comparative Effectiveness Review of Treatment Modalities
Comparative Effectiveness Reviews, No. 127
Investigators: Jonathan Zenilman, MD, M Frances Valle, DNP, MS, Mahmoud B Malas, MD, MHS, Nisa Maruthur, MD, MHS, Umair Qazi, MPH, Yong Suh, MBA, MSc, Lisa M Wilson, ScM, Elisabeth B Haberl, BA, Eric B Bass, MD, MPH, and Gerald Lazarus, MD.
Author Information and AffiliationsStructured Abstract
Objectives:
To systematically review whether the use of advanced wound dressings, systemic antibiotics, or venous surgery enhanced the healing of venous ulcers over the use of adequate venous compression.
Data sources:
MEDLINE®, Embase®, the Cochrane Central Register of Controlled Trials, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL®) from January 1980 through July 2012.
Review methods:
We included studies of patients with venous leg ulcers lasting 6 or more weeks coincident with signs of preexisting venous disease. We excluded patients with arterial ulcers, pressure ulcers, postsurgical ulcers, and neuropathic ulcers. To select articles for analysis, teams of two independent investigators reviewed titles, abstracts, and articles. Conflicts between investigators regarding inclusion were negotiated. We found insufficient data for meta-analysis but qualitatively summarized studies not amenable to pooling.
Results:
Our search retrieved over 10,000 articles. We included 60 studies (62 publications). Most of the studies of advanced wound dressings that regulate moisture, facilitate debridement, include antimicrobial activity, or incorporate putative wound healing accelerants did not demonstrate a statistically higher percentage of wounds healed compared with adequate compression with simple dressings. However, the newer biological dressings containing living cells such as the cellular human skin equivalents showed more rapid healing of venous ulcers (moderate strength of evidence).We could not draw definitive conclusions regarding the effectiveness of advanced wound dressings in terms of intermediate and other final outcomes, including quality of life and pain measures. We found insufficient evidence evaluating the benefits and harms of the routine use of antibiotics. Most venous surgery may not increase the proportion of ulcers healed (low to high strength of evidence), although there was a trend toward greater durability of healing.
Conclusions:
These findings do not mean that the interventions do not have value. Rather, the risk of bias and lack of adequate sample size prevented us from establishing statistically valid conclusions. Many of the studies did not report statistical analyses beyond simple healing rates, stratification or adjustment to account for potential confounding variables, or sample size calculations. Many of the studies reviewed were small and therefore had limited power. The absence of these critical design elements limited our ability to draw conclusions. We suggest that there be consensus to frame a series of commonly agreed-upon definitions, develop model clinical research approaches, consider mutually agreed-upon schemes to classify patients, quantify healing parameters, and consider the development of research wound healing networks to collect sufficient number of patients to produce valid conclusions.
Contents
- Preface
- Acknowledgments
- Key Informants
- Technical Expert Panel
- Peer Reviewers
- Executive Summary
- Introduction
- Methods
- Results
- Search Results
- Key Question 1 For patients with chronic venous leg ulcers, what are the benefits and harms of using dressings that regulate wound moisture with or without active chemical, enzymatic, biologic, or antimicrobial components in conjunction with compression systems when compared with using solely compression systems?
- Key Question 2a For patients with chronic venous leg ulcers that do not have clinical signs of cellulitis that are being treated with compression systems, what are the benefits and harms of using systemic antibiotics when compared with using solely compression systems?
- Key Question 2b For patients with chronic venous leg ulcers that do not have clinical signs of cellulitis that are being treated with dressings that regulate wound moisture with or without active chemical, enzymatic, biologic, or antimicrobial components, what are the benefits and harms of using systemic antibiotics when compared with using dressings alone?
- Key Question 3a For patients with chronic venous leg ulcers, what are the benefits and harms of surgical procedures aimed at the underlying venous abnormalities when compared with using solely compression systems?
- Key Question 3b For patients with chronic venous leg ulcers, what are the comparative benefits and harms of different surgical procedures for a given type of venous reflux and obstruction?
- Discussion
- References
- Abbreviations
- Appendix A Detailed Electronic Database Search Strategies
- Appendix B Forms
- Appendix C Excluded Articles
- Appendix D Evidence Tables
Erratum January 2014
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.
Associate Editor: Karen Schoelles, MD, SM, ECRI Evidence-based Practice Center, Plymouth Meeting, PA
AHRQ Contacts: Christine Chang, MD, MPH, Task Order Officer, Evidence-based Practice Center Program, Agency for Healthcare Research and Quality, Rockville, MD
Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services1, Contract No. 290-2007-10061-I. Prepared by: Johns Hopkins University Evidence-based Practice Center, Baltimore, MD
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.
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.
None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.
- 1
540 Gaither Road, Rockville, MD 20850; www
.ahrq.gov
- Review Systematic reviews of wound care management: (3) antimicrobial agents for chronic wounds; (4) diabetic foot ulceration.[Health Technol Assess. 2000]Review Systematic reviews of wound care management: (3) antimicrobial agents for chronic wounds; (4) diabetic foot ulceration.O'Meara S, Cullum N, Majid M, Sheldon T. Health Technol Assess. 2000; 4(21):1-237.
- Review Comparative effectiveness of advanced wound dressings for patients with chronic venous leg ulcers: a systematic review.[Wound Repair Regen. 2014]Review Comparative effectiveness of advanced wound dressings for patients with chronic venous leg ulcers: a systematic review.Valle MF, Maruthur NM, Wilson LM, Malas M, Qazi U, Haberl E, Bass EB, Zenilman J, Lazarus G. Wound Repair Regen. 2014 Mar-Apr; 22(2):193-204.
- Review Comparative effectiveness of surgical interventions aimed at treating underlying venous pathology in patients with chronic venous ulcer.[J Vasc Surg Venous Lymphat Dis...]Review Comparative effectiveness of surgical interventions aimed at treating underlying venous pathology in patients with chronic venous ulcer.Malas MB, Qazi U, Lazarus G, Valle MF, Wilson LM, Haberl EB, Bass EB, Zenilman J. J Vasc Surg Venous Lymphat Disord. 2014 Apr; 2(2):212-25. Epub 2013 Dec 13.
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