To evaluate whether the time to complete closure is superior for RECELL-treated split-thickness donor sites, compared with Control (standardized dressings only). The mean time for donor site healing will be compared between treatments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
3
Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings
Telfa™ Clear and Xeroform™ dressings
Arizona Burn Center at Maricopa Intergrated Health Systems
Phoenix, Arizona, United States
Shriners Hospital for Children, Northern California
Sacramento, California, United States
University of California at San Diego
San Diego, California, United States
University of Iowa Hospitals and Clinics
Time to Complete Closure
The primary effectiveness endpoint is time, in days, to complete closure (≥95% epithelialization by blinded assessor) of study donor sites confirmed at two consecutive visits.
Time frame: up to 4 weeks
Donor Site Treatment Preference (Site A or Site B) Reported by Subject
Subject will be asked which donor site (A or B) they prefer (if subject is less than 8 years of age parents will be asked)
Time frame: 4 weeks
Donor Site Treatment Preference (Site A or Site B) Reported by Physician
Physician will be asked which donor site (A or B) they prefer
Time frame: 4 weeks
Comparative Itching of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was Itchier After Treatment
Comparative Itching of study donor sites during 1st week post treatment by asking which site was itchier after treatment
Time frame: Day 7
Comparative Pain of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was More Painful Since Treatment
Comparative pain of study donor sites during 1st week post treatment by asking the child which site was more painful since treatment
Time frame: Day 7 or 8
Blinded Evaluator Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS)
Blinded Evaluator Overall Opinion POSAS Score of study donor sites. The Overall Opinion Score uses a 10-point scale where 10 corresponds to the worst imaginable scar.
Time frame: Week 24
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Iowa City, Iowa, United States
Shriners Hospital for Children, Boston
Boston, Massachusetts, United States
Akron Children's Hospital
Akron, Ohio, United States
University of Washington Regional Burn Center at Harborview Medical Center
Seattle, Washington, United States
Patient Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS)
Patient Overall Opinion POSAS Score of study donor sites(reported by subject 8 years of age or older, or by parent/guardian if subject less than 8 years of age). The Overall Opinion Score uses a 10-point scale where 10 corresponds to the worst imaginable scar.
Time frame: Week 24