RES Prepared With RECELL® Compared to Conventional Care for Healing of Donor Sites in Ages 1-16 Years

Not Applicable

Terminated

Conditions: Skin; Deformity

Interventions: Other: Telfa™ Clear and Xeroform™ dressings
Device: 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

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.
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:
1. Understand the full nature and purpose of the study, including possible risks and adverse events, and
2. 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.

Exclusion Criteria

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
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Seattle, Washington, United States
University of California at San Diego
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San Diego, California, United States
University of Iowa Hospitals and Clinics
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Iowa City, Iowa, United States
Arizona Burn Center at Maricopa Intergrated Health Systems
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Phoenix, Arizona, United States
Shriners Hospital for Children, Boston
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Boston, Massachusetts, United States
Akron Children's Hospital
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Akron, Ohio, United States
Shriners Hospital for Children, Northern California
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Sacramento, California, United States