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Advanced Tissue Sciences, La Jolla, Ca, announced the Food and Drug Administration has approved Dermagraft-TC for marketing, making it the first human fibroblast-derived temporary skin substitute to be approved. Dermagraft-TC is indicated for use as a temporary wound covering for severe thermal burns in patients who require such a covering prior to autograft placement. It is immediately available in burn treatment centers across the country, the company reported.
The approval of Dermagraft-TC was based on data from a pivotal clinical trial which demonstrated that after two weeks, the mean autograft take (the primary endpoint of the trial) of wounds treated with Dermagraft-TC was statistically equivalent to that of wounds treated with allograft, Advanced Tissue Sciences said. …
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