A Multicenter Clinical Trial of a Biosynthetic Skin Replacement, Dermagraft-TC, Compared with Cryopreserved Human Cadaver Skin for Temporary Coverage of Excised Burn Wounds


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Abstract

This multicenter study compared die use of a biosyntlietic human skin substitute with frozen human cadaver allograft for die temporary closure of excised burn wounds. Dermagraft-TC (Advanced Tissue Sciences, Inc.) (DG-TC) consists of a synthetic material onto which human neonatal fibroblasts are cultured. Burn wounds in 66 patients with a mean age of 36 years and a mean burn size of 44% total body surface area (28% total body surface area full-thickness) were surgically excised. Two comparable sites, each approximately 1% total body surface area in size, were randomized to receive either DG-TC or allograft. Bodi sites were then treated in the same manner. When clinically indicated (>5 days after application) both skin replacements were removed, and the wound beds were evaluated and prepared for grafting. DG-TC was equivalent or superior to allograft with regard to autograft take at post autograft day 14. DG-TC was also easier to remove, had no epidermal slough, and resulted in less bleeding than did allograft while maintaining an adequate wound bed. Overall satisfaction was better widi DG-TC.

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