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.