RES Prepared With RECELL® Compared to Conventional Care for Healing of Donor Sites in Ages 1-16 Years
A Prospective Multicenter Randomized Controlled Clinical Study to Investigate the Safety and Effectiveness of RES (Regenerative Epidermal Suspension) Prepared With the RECELL® Device Compared to Conventional Care for Healing of Donor Sites in Infants, Children and Adolescents (Aged 1-16 Years)
Doctors at the Arizona Burn Center are investigating the comparative healing time at skin donation sites (for burn patients) when standard dressings are used versus the RECELL® System regenerative epidermal suspension spray. RECELL isolates skin cells from a small skin sample and immerses it in an enzyme solution to produce Spray-On Skin™ Cells. The regenerative epidermal suspension includes the key skin cells which play a critical role in healing.
Participants will be assigned to either receive the experimental treatment or standard wound dressings, and donor site wound closure will be followed for up to 52 weeks.
- Be 1 to 16 years of age
- 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
THE STUDY INVOLVES:
- Prescreening tests to confirm eligibility of the patient to participate.
- Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings (or only the same dressings, if assigned that treatment).
- Donor site wound closure will be followed for up to 52 weeks.
LOCATIONS AND CONTACTS:
Trials will take place at the Arizona Burn Center at Maricopa Integrated Health Systems in Phoenix, AZ. Map.
Contact: Elizabeth Kirshner | 661-877-6869 | [email protected]
Contact: Lisa Carothers | 661-568-1311 | [email protected]
Biomedical Advanced Research and Development Authority
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