ReCell® Combined With Meshed Skin Graft in the Treatment of Acute Burn Injuries (NCT02380612) | Clinical Trial Compass
CompletedNot Applicable
ReCell® Combined With Meshed Skin Graft in the Treatment of Acute Burn Injuries
United States30 participantsStarted 2015-01-26
Plain-language 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.
Who can participate
Age range5 Years
SexALL
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Inclusion criteria
✓. The subject requires skin grafting as a result of an acute thermal burn injury (i.e. injuries caused by exposure of the skin to fire/flames, excessive heat, hot steam or water).
✓. The area of total burn injury is 5-50% TBSA inclusive.
✓. Two areas requiring skin grafting, each at least 300cm2 (or 600cm2 contiguous), excluding hand/face and joints.
✓. The subject is at least 5 years of age.
✓. The subject (or family, for those under 18 years of age) is willing and able to complete all followup evaluations required by the study protocol.
✓. The subject is to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary.
✓. The subject agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.
✓. The subject and/or guardian are able to read and understand instructions and give informed, voluntary, written consent.
Exclusion criteria
What they're measuring
1
Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority)
Timeframe: Prior to or at 8 weeks
2
Actual Expansion Ratios (Treatment Area to Donor Site Area, Inclusive of Donor Skin Needed for Secondary Treatments)