A prospective randomized within-subject controlled study to compare the clinical performance of conventional autografting with and without the RECELL system on acute non-burn full-thickness skin defects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
Meshed split-thickness skin graft, with standardized wound dressings (Telfa™ Clear and Xeroform™)
More widely meshed split-thickness skin graft, Spray-on Skin™ Cells prepared using RECELL, and standardized wound dressings (Telfa™ Clear and Xeroform™)
Arizona Burn Center - Valleywise Health
Phoenix, Arizona, United States
University of Arizona - Banner Health
Tucson, Arizona, United States
UCI Medical Center
Orange, California, United States
Lundquist Institute @Harbor UCLA
Torrance, California, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Kendall Regional Medical Center
Miami, Florida, United States
Cook County Health
Chicago, Illinois, United States
Carle Foundation Hospital
Urbana, Illinois, United States
University Medical Center
New Orleans, Louisiana, United States
University of Rochester Medical Center
New York, New York, United States
...and 8 more locations
Incidence of Treatment Area Healing
The incidence of healing is hypothesized to be non-inferior for RECELL-treated areas (Investigational Intervention) as compared to Control areas (Control Intervention). Healing is defined as complete wound closure characterized by 100% skin re-epithelialization without drainage, confirmed at two consecutive study visits at least 2 weeks apart by direct visualization by a Blinded Evaluator.
Time frame: Prior to or at 8 weeks
Donor Skin Area to Treatment Area Expansion Ratio
The donor skin expansion achieved with treatment using RECELL and widely meshed autograft (Investigational Intervention) is hypothesized to be superior to the donor skin expansion ratio achieved with conventional autograft treatment (Control Intervention). Expansion ratio, computed as the ratio of measured treated area to the measured donor site area, is calculated separately for each Intervention (including any donor skin needed for repeat treatments).
Time frame: Treatment Day
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