TRANSCYTE® is a human fibroblast-derived temporary skin substituteconsisting of a polymer membrane and donated neonatal humanfibroblast cells cultured under aseptic conditions in vitro on a nylonmesh. Prior to cell growth, this nylon mesh is coated with porcinedermal collagen and bonded to a polymer membrane (silicone). Thismembrane provides a transparent synthetic epidermis when applied.As fibroblasts proliferate within the nylon mesh, they secrete humandermal collagen, matrix proteins and growth factors. Following freezing,no cellular metabolic activity remains; however, the tissue matrix andbound growth factors are left intact. The human fibroblast-derivedtemporary skin substitute provides a temporary protective barrier.TRANSCYTE is transparent and allows direct visual monitoring of thewound bed.
A sterile covering used as a temporary skin substitute on wounds (e.g., diabetic or venous insufficiency ulcers) or burns that involve the dermis, and that provides a matrix, typically of living cells (fibroblasts) and/or structural proteins, to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device contains human- and animal-derived products (e.g., bovine, porcine), or only animal-derived products. It may be mono- or bi-layered, and may contain natural and synthetic materials. This is a single-use device.