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Home » Publications » Medical journals » Specialized Medicine journals » Transplant News » March 1997 »

Advanced Tissue Sciences' temporary wound covering Dermagraft-TC approved for marketing by FDA

Transplant News
Transplant News

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March 28, 1997 | Copyright
COPYRIGHT 1999 Transplant Communications, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights or concerns about this content should be directed to Customer Service.
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    <a href="https://www.highbeam.com/doc/1G1-47248437.html" title="Advanced Tissue Sciences' temporary wound covering Dermagraft-TC approved for marketing by FDA | HighBeam Research">Advanced Tissue Sciences' temporary wound covering Dermagraft-TC approved for marketing by FDA</a>

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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