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)
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.
• 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.
• The patient and family member/parent/guardian are able to complete all follow-up evaluations required by the study protocol.
• In the opinion of the Investigator, the patient and/or parent/guardian must be able to:
‣ Understand the full nature and purpose of the study, including possible risks and adverse events, and
⁃ Provide informed consent/assent as appropriate for study participation.
• The patient and/or parent/guardian agrees to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary and comply with all compulsory study procedures.
• The patient and/or parent/guardian agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.
• The patient and/or parent/guardian can read and understand instructions and give informed, voluntary, written consent.
• Life expectancy greater than 52 weeks.