StrataGraft skin tissue as an Alternative to Autografting Full-thickness Complex Skin Defects ClinicalTrials.gov Identifier: NCT03005054
This is a phase II open-label, controlled, randomized, multicenter, dose-escalation study of the safety, tolerability, and efficacy of a single or multiple applications of StrataGraft skin tissue as an alternative to autografting in promoting the healing of excised full-thickness complex skin defects resulting from acute traumatic skin loss. The goal of this study is to determine whether single or repeated application of StrataGraft® skin substitute can promote tissue regeneration in areas of full-thickness skin loss.
StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements. ClinicalTrials.gov Identifier: NCT03005106
This study is an 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 that contain intact dermal elements and for which excision and autografts are clinically indicated. The goal of this proposal is to perform late-stage development activities to support the approval and licensure of StrataGraft tissue.
The Acute Burn Resuscitation Multicenter Prospective Observational Trial (ABRUPT). ClinicalTrials.gov Identifier: NCT03144427
This is a prospective, non-interventional, observational study of consecutive burn patients admitted to 20 selected burn centers in North America. Primarily, data collection will be continuous “real-time” documentation of fluid infusion rates, vital signs and laboratory values of patients receiving fluid resuscitation during the first 48 hours following burn injury. The ABRUPT (Acute Burn Resuscitation Multicenter Prospective Observational Trial) study findings will be used to design a definitive prospective randomized trial to evaluate crystalloids versus colloids during burn shock resuscitation.