RES Prepared With RECELL® Compared to Conventional Care for Healing of Donor Sites in Ages 1-16 Years
- Conditions
- Skin; Deformity
- Interventions
- Other: Telfa™ Clear and Xeroform™ dressingsDevice: RECELL® Autologous Cell Harvesting Device
- Registration Number
- NCT03624192
- Lead Sponsor
- Avita Medical
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
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Male or female patients aged 1 through 16 years (inclusive) with a skin defect for which autografting is indicated.
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The area of total injury or planned defect (excluding donor sites) is 5% to 25% Total Body Surface Area (TBSA), inclusive.
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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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The patient and family member/parent/guardian are able to complete all follow-up evaluations required by the study protocol.
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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.
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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.
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The patient and/or parent/guardian agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.
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The patient and/or parent/guardian can read and understand instructions and give informed, voluntary, written consent.
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Life expectancy greater than 52 weeks.
- Prior autograft harvest at planned study donor sites.
- Patients with sepsis or hemodynamic instability.
- The patient has an infection under active management or other dermatologic condition at the planned donor sites or treatment areas.
- Patient (of reasonable age) or parent/guardian is unable to follow the protocol requirements.
- The patient has other concurrent conditions that in the opinion of the Investigator may compromise patient safety or study objectives.
- Patients with a known hypersensitivity to trypsin or compound sodium lactate for irrigation.
- In post-pubescent girls, pregnant or breast-feeding (pregnancy test should be performed in accordance with local institutional requirements).
- Enrollment in a concurrent study in which the study treatment may confound the endpoints of this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telfa™ Clear and Xeroform™ dressings Telfa™ Clear and Xeroform™ dressings Telfa™ Clear and Xeroform™ dressings RECELL® Autologous Cell Harvesting Device RECELL® Autologous Cell Harvesting Device RECELL + Telfa™ Clear and Xeroform™ dressings
- Primary Outcome Measures
Name Time Method Time to Complete Closure up to 4 weeks 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.
- Secondary Outcome Measures
Name Time Method Comparative Itching of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was Itchier After Treatment Day 7 Comparative Itching of study donor sites during 1st week post treatment by asking which site was itchier after treatment
Blinded Evaluator Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS) Week 24 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.
Donor Site Treatment Preference (Site A or Site B) Reported by Subject 4 weeks 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)
Comparative Pain of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was More Painful Since Treatment Day 7 or 8 Comparative pain of study donor sites during 1st week post treatment by asking the child which site was more painful since treatment
Patient Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS) Week 24 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.
Donor Site Treatment Preference (Site A or Site B) Reported by Physician 4 weeks Physician will be asked which donor site (A or B) they prefer
Trial Locations
- Locations (7)
University of Washington Regional Burn Center at Harborview Medical Center
🇺🇸Seattle, Washington, United States
University of California at San Diego
🇺🇸San Diego, California, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Arizona Burn Center at Maricopa Intergrated Health Systems
🇺🇸Phoenix, Arizona, United States
Shriners Hospital for Children, Boston
🇺🇸Boston, Massachusetts, United States
Akron Children's Hospital
🇺🇸Akron, Ohio, United States
Shriners Hospital for Children, Northern California
🇺🇸Sacramento, California, United States