Health Problem: Venous leg ulcers, also known as venous stasis ulcers or varicose ulcers, are partial or full-thickness defects in the skin of the lower leg, typically between the knee and the ankle, caused by venous hypertension as a result of valvular incompetence and venous reflux. These wounds impair function and quality of life, and chronic venous leg ulcers are susceptible to infection.

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 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 a heterogeneous group of products and can generally be classified into 3 main types: cellular (comprised of living cells), acellular (composed of synthetic materials or tissue from which living cells have been removed), or a combination of cellular and acellular components. 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 standard wound care alone, what is the efficacy of skin substitutes, in terms of the proportion of patients with complete ulcer healing, time to ulcer healing, and quality of life?
  • 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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