This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Contact me when this article is cited  Related Content  • Similar articles in JAMA  Topic Collections  • Dermatology  • Alert me on articles by topic

Bernard A. Schwetz, DVM,PhD

JAMA. 2001;285:1696.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

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.

Composite cultured skin was approved as a humanitarian-use device designed for a US patient population of 4000 or fewer per year, which requires evidence of probable benefit. In Australia, results of 15 operations (in seven patients) to release hand contractures using CCS were judged by . . . [Full Text of this Article]

Acting Principal Deputy Commissioner
Food and Drug Administration