ReCell® Combined With Meshed Skin Graft in the Treatment of Acute Burn Injuries

NCT02380612 | Completed Results

• 1 other identifier: CTP001-6
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 7

Brief Summary

This is a randomized, within-subject controlled study to compare the clinical performance of the ReCell device when used as an adjunct to meshed skin graft in subjects requiring skin grafts for closure of burn injuries. Co-primary effectiveness endpoints include: (1) confirmed treatment area closure (i.e., healing) prior to or at 8 weeks as assessed by a blinded evaluator, and (2) a comparison of the actual expansion ratio, computed as the ratio of measured treated area to the measured donor site area, achieved for the ReCell-treated and control treatment areas. Safety will be evaluated in terms of long-term durability, scar outcomes and treatment-related adverse events.

Conditions

Burns

Keywords

Second Degree Burn Injuries

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority)

  Complete wound closure is defined as skin re-epithelialization without drainage, confirmed at two consecutive study visits at least 2 weeks apart by direct visualization by a qualified clinician blinded to treatment assignment. The incidence of complete wound closure is hypothesized to be non-inferior for RECELL-treated areas as compared to control areas.

  Prior to or at 8 weeks

• Actual Expansion Ratios (Treatment Area to Donor Site Area, Inclusive of Donor Skin Needed for Secondary Treatments)

  For this second co-primary endpoint, it is hypothesized that the expansion ratio associated with the RECELL treatment area will be superior to that of the control, i.e. less donor skin will be required for RECELL-treated areas compared with the control areas.

  Prior to or at 8 weeks

Secondary Outcomes (3)

• Observer Overall Patient and Observer Scar Assessment Scale ( POSAS) Opinion Score

  At 24 Week

• Patient's Satisfaction/Treatment Preference

  At 24 Week

• Patient Overall Patient and Observer Scar Assessment Scale (POSAS) Opinion Score

  Week 24

Study Arms (1)

All Participants (within patient control)

EXPERIMENTAL

All subjects will receive both ReCell and skin graft. Each patient serves as their own control. Their study treatment area (burn injury) will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B

Device: ReCell Treatment; Procedure: Skin Graft

Interventions

ReCell Treatment DEVICE

All Participants (within patient control)

Skin Graft PROCEDURE

All Participants (within patient control)

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject requires skin grafting as a result of an acute thermal burn injury (i.e. injuries caused by exposure of the skin to fire/flames, excessive heat, hot steam or water).
• The area of total burn injury is 5-50% TBSA inclusive.
• Two areas requiring skin grafting, each at least 300cm2 (or 600cm2 contiguous), excluding hand/face and joints.
• The subject is at least 5 years of age.
• The subject (or family, for those under 18 years of age) is willing and able to complete all followup evaluations required by the study protocol.
• The subject is to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary.
• The subject agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.
• The subject and/or guardian are able to read and understand instructions and give informed, voluntary, written consent.

You may not qualify if:

• The subject's burn injuries were caused by chemicals, electricity, and/or radioactive substances.
• The subject is unable to follow the protocol.
• The subject has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives.
• The subject has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (Hartmann's) solution.
• Life expectancy is less than 1 year.

Sponsors & Collaborators

• Avita Medical: lead
• MedDRA Assistance Inc: collaborator
• Advanced Clinical Research Services, LLC: collaborator

Study Sites (7)

Arizona Burn Center at Maricopa Medical Center

Phoenix, Arizona, 85008, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

North Carolina Jaycee Burn Center

Chapel Hill, North Carolina, 27599, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

University of Tennessee Health Science Center

Memphis, Tennessee, 38103-3409, United States

Location

USAISR - US Army Institute of Surgical Research

Fort Sam Houston, Texas, 78234, United States

Location

MeSH Terms

Conditions

Burns

Interventions

Skin Transplantation

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Dermatologic Surgical Procedures; Plastic Surgery Procedures; Surgical Procedures, Operative; Transplantation

Results Point of Contact

• Title: VP Clinical Research
• Organization: AVITA Medical

clinicaltrial@avitamedical.com

661-367-9170

Study Officials

• James H Holmes, IV, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The participant and blinded evaluator will be not be told which treatment area received which treatment (RECELL or Control).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2015
• First Posted: March 5, 2015
• Study Start: January 26, 2015
• Primary Completion: January 21, 2016
• Study Completion: February 1, 2017
• Last Updated: January 7, 2025
• Results First Posted: February 23, 2021

Record last verified: 2024-12

Locations

US (7)