RES Prepared With RECELL® Compared to Conventional Care for Healing of Donor Sites in Ages 1-16 Years
Recruiting at6 trial locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Avita Medical
No Placebo Group
Trial Summary
What is the purpose of this trial?
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.
Research Team
Eligibility Criteria
Inclusion Criteria
Male or female patients aged 1 through 16 years (inclusive) with a skin defect for which autografting is indicated.
The area of total injury or planned defect (excluding donor sites) is 5% to 25% Total Body Surface Area (TBSA), inclusive.
Two discrete donor sites of similar size (± 25%) can be created in a similar non-articulating location (excluding the scalp) with each donor site representing a minimum of 1% TBSA.
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Treatment Details
Interventions
- RECELL® Autologous Cell Harvesting Device (Autologous Cell Therapy)
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: RECELL® Autologous Cell Harvesting DeviceExperimental Treatment1 Intervention
RECELL + Telfa™ Clear and Xeroform™ dressings
Group II: Telfa™ Clear and Xeroform™ dressingsActive Control1 Intervention
Telfa™ Clear and Xeroform™ dressings
Find a Clinic Near You
Who Is Running the Clinical Trial?
Avita Medical
Lead Sponsor
Trials
18
Recruited
720+
Biomedical Advanced Research and Development Authority
Collaborator
Trials
108
Recruited
574,000+
Tara O'Toole
Biomedical Advanced Research and Development Authority
Chief Executive Officer since 2011
MD, MPH
Matthew Memoli
Biomedical Advanced Research and Development Authority
Chief Medical Officer
MD