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)

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.

Study Overview

• Status: Terminated
• Conditions: Skin; Deformity
• Intervention / Treatment: Device: RECELL® Autologous Cell Harvesting Device; Other: Telfa™ Clear and Xeroform™ dressings

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85008
      • Arizona Burn Center at Maricopa Intergrated Health Systems
  • California
    • Sacramento, California, United States, 95817
      • Shriners Hospital for Children, Northern California
    • San Diego, California, United States, 92103
      • University of California at San Diego
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Shriners Hospital for Children, Boston
  • Ohio
    • Akron, Ohio, United States, 44308
      • Akron Children's Hospital
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington Regional Burn Center at Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 16 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female patients aged 1 through 16 years (inclusive) with a skin defect for which autografting is indicated.
2. The area of total injury or planned defect (excluding donor sites) is 5% to 25% Total Body Surface Area (TBSA), inclusive.
3. 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.
4. The patient and family member/parent/guardian are able to complete all follow-up evaluations required by the study protocol.

5. 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.
6. 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.
7. The patient and/or parent/guardian agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.
8. The patient and/or parent/guardian can read and understand instructions and give informed, voluntary, written consent.
9. Life expectancy greater than 52 weeks.

Exclusion Criteria:

1. Prior autograft harvest at planned study donor sites.
2. Patients with sepsis or hemodynamic instability.
3. The patient has an infection under active management or other dermatologic condition at the planned donor sites or treatment areas.
4. Patient (of reasonable age) or parent/guardian is unable to follow the protocol requirements.
5. The patient has other concurrent conditions that in the opinion of the Investigator may compromise patient safety or study objectives.
6. Patients with a known hypersensitivity to trypsin or compound sodium lactate for irrigation.
7. In post-pubescent girls, pregnant or breast-feeding (pregnancy test should be performed in accordance with local institutional requirements).
8. Enrollment in a concurrent study in which the study treatment may confound the endpoints of this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator's (Unblinded) Assessment of Healing at All RECELL-treated Areas by Direct Observation	Investigator's (unblinded) assessment of healing at all RECELL-treated areas including study donor sites by direct observation	Through Week 52
Mean Subject Reported Pain Score Before and After Dressing Changes	Mean subject (or parent/guardian) reported study donor site pain prior to and after dressing changes. Faces Pain Scale-Revised (FPS-R) or Numeric Rated Pain Scale will be used based on the child's age. Both scales use a 10-point scale where 10 is the worst pain imaginable or very much pain.	Up to Week 4
Mean Subject Reported Study Donor Site Itching Score Prior to Dressing Changes	Mean subject (or parent/guardian) reported study donor site itching score prior to dressing changes using the Itch Man Scale (0-4) where 4 represents itching most terribly	Up to Week 4
Health Care Provider's Mean Pain Score Associated With Dressing Changes at Study Donor Sites	Mean pain score associated with dressing changes at study donor sites assessed by the health care provider performing the dressing change using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The scale is scored in a range of 0-10 with 0 representing no pain.	Up to Week 4
Blinding Effectiveness by Asking the Blinded Evaluator Which Treatment They Think the Donor Sites (A and B) Received	Blinding effectiveness by asking the Blinded Evaluator which treatment they think the donor sites (A and B) received	Week 4 and 24

Collaborators and Investigators

• Sponsor: Avita Medical
• Collaborators: Biomedical Advanced Research and Development Authority

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2018
• Primary Completion (Actual): January 13, 2020
• Study Completion (Actual): January 13, 2020

Study Registration Dates

• First Submitted: July 20, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: July 9, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Pediatric, Complex Skin Deformities
• Additional Relevant MeSH Terms: Skin Diseases; Congenital Abnormalities; Skin Abnormalities
• Other Study ID Numbers: CTP006-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes