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Skin substitute clinical trial a success, Stratatech reports

The Capital Times  —  9/30/2008 5:34 pm

Madison-based Stratatech Corp. announced Monday the successful completion of a clinical trial of its StrataGraft human skin substitute.

The company said the trial showed StrataGraft performed comparable to the current standard of care.

The clinical trial was designed to evaluate the safety and effectiveness of StrataGraft in patients with major skin trauma that required temporary skin replacement before "autografting" -- the transplantation of live skin tissue from one part of a patient's body to another.

The company said the primary goal was autograft engraftment or "take" two weeks after autograft placement. Each half of a patient's wound site was pre-treated with StrataGraft skin substitute or the standard of care prior to autografting. There was no difference in autograft take between wound sites pre-treated with StrataGraft skin substitute or the standard of care.

Overall, StrataGraft skin substitute maintained physical integrity following placement, appeared healthy at periodic visual inspections and provided a wound bed suitable for autografting, Stratatech said.

During the multicenter, 15-patient trial, Stratatech said no adverse or serious adverse events were associated with exposure to StrataGraft.

The clinical trial data was presented during the annual meeting of the American Association for the Surgery of Trauma. The University of Wisconsin-Madison's Michael J. Schurr was the trial's principal clinical investigator.

Gov. Jim Doyle issued a statement praising Stratatech, which in August received $750,000 from the state to help develop new techniques to use genetically enhanced human skin substitutes that can heal wounds.

"Stratatech is one of the country's leading regenerative medicine companies and I am pleased to see that our investment is paying off," Doyle said. "Biotechnology is a competitive industry, and it's important that in Wisconsin we continue to support companies like Stratatech that have the potential to achieve incredible breakthroughs that will save lives."

The Capital Times  —  9/30/2008 5:34 pm