This article was originally published in The Gray Sheet
Executive SummaryTemporarily halts clinical trials of its Acticel wound dressing for treatment of burn patient donor site wounds after finding an "equivocal" reduction in average healing time for the indication. Pilot studies had shown a "clinically significant" time reduction, according to the company. BioSurface is conducting an "intensive" analysis of both data and study design to determine how best to proceed. Acticel trials in five other indications, such as deep partial thickness burns and pressure ulcers ("The Gray Sheet" Jan. 11, p. 16), will continue.
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