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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Skin; Deformity

Intervention / Treatment
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* Device: RECELL® Autologous Cell Harvesting Device
* Other: Telfa™ Clear and Xeroform™ dressings


Participation Criteria
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Eligibility Criteria
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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: 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. 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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each subject serves as their own control.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RECELL® Autologous Cell Harvesting Device<br>RECELL + Telfa™ Clear and Xeroform™ dressings | Device: RECELL® Autologous Cell Harvesting Device<br>* Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings<br>* Other names: RES (Regenerative Epidermal Suspension);|
| Active Comparator: Telfa™ Clear and Xeroform™ dressings<br>Telfa™ Clear and Xeroform™ dressings | Other: Telfa™ Clear and Xeroform™ dressings<br>* Telfa™ Clear and Xeroform™ dressings<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Complete Closure | 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. | up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Donor Site Treatment Preference (Site A or Site B) Reported by Subject | 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) | 4 weeks | 
| Donor Site Treatment Preference (Site A or Site B) Reported by Physician | Physician will be asked which donor site (A or B) they prefer | 4 weeks | 
| Comparative Itching of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was Itchier After Treatment | Comparative Itching of study donor sites during 1st week post treatment by asking which site was itchier after treatment | Day 7 | 
| Comparative Pain of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was More Painful Since Treatment | Comparative pain of study donor sites during 1st week post treatment by asking the child which site was more painful since treatment | Day 7 or 8 | 
| Blinded Evaluator Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS) | 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. | Week 24 | 
| Patient Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS) | 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. | Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric, Complex Skin Deformities