1. Multicenter postapproval clinical trial of Integra dermal regeneration template for burn treatment.
- Author
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Heimbach DM, Warden GD, Luterman A, Jordan MH, Ozobia N, Ryan CM, Voigt DW, Hickerson WL, Saffle JR, DeClement FA, Sheridan RL, and Dimick AR
- Subjects
- Adolescent, Adult, Aged, Aged, 80 and over, Burns mortality, Child, Child, Preschool, Chondroitin Sulfates, Collagen, Female, Humans, Infant, Male, Middle Aged, Trauma Severity Indices, United States, Wound Infection mortality, Biocompatible Materials adverse effects, Biocompatible Materials therapeutic use, Burns complications, Burns therapy, Dermis physiopathology, Regeneration physiology, Wound Infection etiology, Wound Infection physiopathology
- 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.
- Published
- 2003
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