At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Demonstration of the Safety and Effectiveness of ReCell® Combined With Meshed Skin Graft for Reduction of Donor Area in the Treatment of Acute Burn Injuries
In Brief
A clinical study evaluating ReCell Treatment and Skin Graft for Burns. Completed, enrolled 30 participants across 7 sites.
Detailed Summary
This is a randomized, within-subject controlled study to compare the clinical performance of the ReCell device when used as an adjunct to meshed skin graft in subjects requiring skin grafts for closure of burn injuries. Co-primary effectiveness endpoints include: (1) confirmed treatment area closure (i.e., healing) prior to or at 8 weeks as assessed by a blinded evaluator, and (2) a comparison of the actual expansion ratio, computed as the ratio of measured treated area to the measured donor site area, achieved for the ReCell-treated and control treatment areas. Safety will be evaluated in terms of long-term durability, scar outcomes and treatment-related adverse events.