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

NCT03624192 | Terminated Results DMC FDA Device

• 1 other identifier: CTP006-1
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 7

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.

Conditions

Skin; Deformity

Keywords

Pediatric, Complex Skin Deformities

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Donor Site Treatment Preference (Site A or Site B) Reported by Subject

  4 weeks

• Donor Site Treatment Preference (Site A or Site B) Reported by Physician

  4 weeks

• Comparative Itching of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) 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

  Day 7 or 8

• Blinded Evaluator Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS)

  Week 24

Other Outcomes (5)

• Investigator's (Unblinded) Assessment of Healing at All RECELL-treated Areas by Direct Observation

  Through Week 52

• Mean Subject Reported Pain Score Before and After Dressing Changes

  Up to Week 4

• Mean Subject Reported Study Donor Site Itching Score Prior to Dressing Changes

  Up to Week 4

Study Arms (2)

RECELL® Autologous Cell Harvesting Device

EXPERIMENTAL

RECELL + Telfa™ Clear and Xeroform™ dressings

Device: RECELL® Autologous Cell Harvesting Device

Telfa™ Clear and Xeroform™ dressings

ACTIVE COMPARATOR

Telfa™ Clear and Xeroform™ dressings

Other: Telfa™ Clear and Xeroform™ dressings

Interventions

RECELL® Autologous Cell Harvesting Device DEVICE

Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings

Also known as: RES (Regenerative Epidermal Suspension)

RECELL® Autologous Cell Harvesting Device

Telfa™ Clear and Xeroform™ dressings OTHER

Telfa™ Clear and Xeroform™ dressings

Also known as: Control

Telfa™ Clear and Xeroform™ dressings

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Avita Medical: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (7)

Arizona Burn Center at Maricopa Intergrated Health Systems

Phoenix, Arizona, 85008, United States

Location

Shriners Hospital for Children, Northern California

Sacramento, California, 95817, United States

Location

University of California at San Diego

San Diego, California, 92103, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Shriners Hospital for Children, Boston

Boston, Massachusetts, 02114, United States

Location

Akron Children's Hospital

Akron, Ohio, 44308, United States

Location

University of Washington Regional Burn Center at Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Skin Abnormalities

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: VP, Clinical Research
• Organization: AVITA Medical

USClinicalTrials@avitamedical.com

661-367-9170

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each subject serves as their own control.

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: August 10, 2018
• Study Start: September 19, 2018
• Primary Completion: January 13, 2020
• Study Completion: January 13, 2020
• Last Updated: July 18, 2024
• Results First Posted: July 28, 2021

Record last verified: 2024-07

Locations

US (7)