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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Arizona Burn Center at Maricopa Medical Center
Phoenix, Arizona, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Tampa General Hospital
Tampa, Florida, United States
North Carolina Jaycee Burn Center
Chapel Hill, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
University of Tennessee Health Science Center
Memphis, Tennessee, United States
USAISR - US Army Institute of Surgical Research
Fort Sam Houston, Texas, United States
Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority)
Complete wound closure is defined as skin re-epithelialization without drainage, confirmed at two consecutive study visits at least 2 weeks apart by direct visualization by a qualified clinician blinded to treatment assignment. The incidence of complete wound closure is hypothesized to be non-inferior for RECELL-treated areas as compared to control areas.
Time frame: Prior to or at 8 weeks
Actual Expansion Ratios (Treatment Area to Donor Site Area, Inclusive of Donor Skin Needed for Secondary Treatments)
For this second co-primary endpoint, it is hypothesized that the expansion ratio associated with the RECELL treatment area will be superior to that of the control, i.e. less donor skin will be required for RECELL-treated areas compared with the control areas.
Time frame: Prior to or at 8 weeks
Observer Overall Patient and Observer Scar Assessment Scale ( POSAS) Opinion Score
The observer component of the Patient and Observer Scar Assessment Scale (POSAS) questionnaire required the blinded evaluator to provide an overall opinion of the treatment area compared to normal skin, scored from 1 (normal skin) to 10 (worst imaginable scar).
Time frame: At 24 Week
Patient's Satisfaction/Treatment Preference
Time frame: At 24 Week
Patient Overall Patient and Observer Scar Assessment Scale (POSAS) Opinion Score
The patient component of the Patient Overall Patient and Observer Scar Assessment Scale (POSAS) questionnaire required the patient to provide an overall opinion of the treatment area compared to normal skin, scored from 1 (normal skin) to 10 (worst imaginable scar). T
Time frame: Week 24
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