A prospective, parallel-arm, randomized (1:1) multicenter trial to demonstrate that RECELL treatment of partial-thickness burn injuries, can safely and effectively increase the incidence of Day 10 healing compared with a standardized wound dressing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
19
Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings.
Application of Mepilex® Ag Wound Dressing
When indicated, conventional autografting in accordance with Investigator's standard practice
Arizona Burn Center / Valleywise Health
Phoenix, Arizona, United States
University of South Florida Tampa General Hospital
Tampa, Florida, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
Incidence of Index Burns With Day 10 Healing
Day 10 healing will be evaluated by an observer blinded to treatment allocation with confirmation at Day 28
Time frame: 10 Days post-treatment
Incidence of Day 21 Healing of the Index Burn
Incidence of Day 21 healing of the Index Burn confirmed on Day 28
Time frame: Day 21, confirmed on Day 28
Incidence of Conventional Autografting to Achieve Healing of the Index Burn
Incidence of conventional autografting to achieve healing of the Index Burn
Time frame: Through Day 28
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University of North Carolina
Chapel Hill, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Evan Hayes Burn Center, Virginia Commonwealth University
Richmond, Virginia, United States
University of Washington Regional Burn Center at Harborview Medical Center
Seattle, Washington, United States