Multicenter Postapproval Clinical Trial of Integra® Dermal Regeneration Template for Burn Treatment


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Abstract

The safety and effectiveness of Integra® Dermal Regeneration Template was evaluated in a postapproval study involving 216 burn injury patients who were treated at 13 burn care facilities in the United States. The mean total body surface area burned was 36.5% (range, 1–95%). Integra® was applied to fresh, clean, surgically excised burn wounds. Within 2 to 3 weeks, the dermal layer regenerated, and a thin epidermal autograft was placed. The incidence of invasive infection at Integra®-treated sites was 3.1% (95% confidence interval, 2.0–4.5%) and that of superficial infection 13.2% (95% confidence interval, 11.0–15.7%). Mean take rate of Integra® was 76.2%; the median take rate was 95%. The mean take rate of epidermal autograft was 87.7%; the median take rate was 98%. This postapproval study further supports the conclusion that Integra® is a safe and effective treatment modality in the hands of properly trained clinicians under conditions of routine clinical use at burn centers.

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