Focus of the Report: This report compares the effectiveness and safety of skin substitutes (cellular and acellular) as an addition to standard wound care (SWC) with SWC alone and compared with the adjunct use of alternative skin substitute products to treat chronic or nonhealing venous leg ulcers in adults.

Technology Description: Skin substitutes are proposed as a treatment to cover open chronic venous ulcers and promote wound healing, with the goals of improving quality of life (QOL) and preventing further morbidity such as infection. They are thought to function by physically covering the wound and providing extracellular matrices to induce regeneration and immune function. Skin substitutes, also known as bioengineered, tissue-engineered, or artificial skin, are heterogeneous and can generally be classified into 2 main types: cellular (comprised of living cells); or acellular (composed of synthetic materials or tissue from which living cells have been removed). Regardless of the source, the skin substitute provides a matrix into which cells can migrate.

Controversy: Skin substitutes are a heterogeneous group of tissue replacements and skin grafts sourced from different materials and subject to different regulatory pathways. Many are very costly. Their relative effectiveness and value are unclear.

Key Questions:

For the adjunct treatment of chronic or nonhealing venous leg ulcers in adults:

  • Compared with SWC alone, what is the efficacy of the addition of an acellular or a cellular skin substitute to SWC in terms of incidence of complete ulcer healing, time to complete ulcer healing, and QOL?

  • What complications are associated with skin substitutes?

  • Do efficacy and safety differ by skin substitute type or specific product?

  • Have definitive patient selection criteria been established for skin substitutes for chronic venous leg ulcers?

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