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From the Food and Drug Administration
April 4, 2001

Artificial Skin for Grafts

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JAMA. 2001;285(13):1696. doi:10.1001/jama.285.13.1696-JFD10003-3-1

The FDA has approved composite cultured skin (CCS; Ortec International Inc, New York, NY) for use in patients with mitten hand deformities due to recessive dystrophic epidermolysis bullosa (RDEB) as an adjunct to standard autograft procedures for covering wounds and donor sites created during reconstructive surgery of the hand.

Composite cultured skin is an aseptically processed wound dressing composed of a bovine collagen matrix in which normal human allogeneic skin cells are cultured in two layers. Donor dermal fibroblasts are cultured on and within the porous sponge side of the collagen matrix, and keratinocytes are cultured on its coated, nonporous side.

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