Trauma-related Wound clinical trials at UC Irvine
1 in progress, 0 open to eligible people
StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements
Sorry, in progress, not accepting new patients
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 approximately 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.
Orange, California and other locations