Clinical Trials

Title   Phase iii open-label, controlled, randomized, multicenter study evaluating the efficacy and safety of stratagraft® skin tissue in promoting autologous skin tissue regeneration of complex skin defects due to thermal burns
Description   The proposed registration study is designed as a phase III open-label, controlled, randomized, multicenter study evaluating the efficacy and safety of StrataGraft skin tissue in promoting autologous skin tissue regeneration of complex skin defects due to thermal burns. The proposed study will include patients with 3-49% total body surface area (TBSA) complex skin defects due to thermal burns with intact dermal elements for which excision and autografting are clinically indicated. The study has been designed to focus on the evaluation of efficacy and safety of StrataGraft skin tissue, while also assessing the potential for StrataGraft skin tissue to promote healing of complex skin defects due to thermal burns as an alternative to donor site harvesting and autografting. Targeted enrollment for this study is up to 70 subjects with complex skin defects caused by thermal burns that containing intact dermal elements and for which surgical excision and autografts are clinically indicated.
IRB Number   1107334-1
Treatment   Thermal Burns
Status   Active
Start Date   09/12/2017
Principal Name   Steven Kahn, MD
Contact Name   Kelley Prutzman

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