Excerpt

A wide variety of wound care products are available for clinicians to choose from when treating chronic wounds. Many of these products are said to mimic or substitute for some aspect of the skin's structure and function to promote healing and wound closure. The materials used to produce these products may be derived from human or animal tissue and may undergo extensive or minimal processing to make the finished product. The extent of processing and the source of the material used in the product also determines what regulatory pathway may be required before the product can be marketed. CMS requested this report on the types of wound care products that are commonly referred to as “skin substitutes” and on the regulatory pathways required for the different types of products. For this report, we have not created a definition for a skin substitute product. Instead we used the products listed under CMS codes Q4101 to Q4122 as a starting point and looked for similar products listed in the U.S. Food and Drug Administration (FDA) product codes to generate a list of products. We included only those products indicated for chronic wounds. We note that FDA does not refer to any product or class of products as “skin substitutes,” and we are not proposing an official classification system.

In addition to identification of the products, a second objective of this review was to begin to characterize the state of the evidence base on skin substitutes as wound care products. To address this objective, we sought to determine the number of RCTs of these products and to assess the efficacy of skin substitutes under the conditions presented in the trials. Systematically reviewing and analyzing all the clinical research on skin substitutes is beyond the scope of this report.

This report specifically examined the use of skin substitutes for treating the following chronic wound types: diabetic foot ulcers, pressure ulcers, and vascular ulcers (including venous ulcers and arterial ulcers). Treatment of burn wounds with skin substitutes is outside the scope of this report.

Contents

• Peer Reviewers
• Skin Substitute Products Considered in This Report
• Executive Summary
• Background
  • Normal Healthy Skin
  • Chronic Wounds
  • Phases of Normal Wound Healing
  • Skin Substitutes
  • Usual Care for Chronic Wounds
  • U.S. Food and Drug Administration Regulations Governing Skin Substitute Products
• Methods
  • Key Questions
  • Analytic Framework
  • Inclusion Criteria
  • Search Strategy
  • Study Risk-of-Bias Assessment
  • Strength of the Evidence Base
  • Data Synthesis
• Results
  • 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]?
  • Human-Derived Products Regulated Solely Under the 21 CFR 1271
  • Human-Derived Products Regulated Through Premarket Approval Process
  • Animal-Derived Products Regulated Through the 510(k) Process
  • Biosynthetic Products Regulated Through the 510(k) Process
  • Products Not Yet Available in the United States for Treating Chronic Wounds
  • 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 care, standard care, synthetic dressings, growth factors, skin grafts, or other treatments used as a comparison) in promoting wound healing for the following outcome measures
  • 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?
• Ongoing Clinical Trials
• Discussion and Conclusions
• References
• Appendix A Methods of Identifying the Literature
• Appendix B Risk of Bias in the Evidence Base
• Appendix C Evidence Tables

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.