A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries

NCT01138917 | Completed Results DMC FDA Device

• 1 other identifier: CTP001-5
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 12

Brief Summary

This is a randomized, within-patient controlled study to compare the clinical performance of the ReCell Device with that of Split-thickness Meshed Skin Grafts for the treatment of second degree burns. The hypothesis to be supported are: 1) non-inferiority with the primary efficacy endpoint defined as recipient site wound closure at week 4 follow-up visit of the ReCell-treated area as compared to that of the STMSG-treated area, and 2)superiority in the healing of the ReCell donor site as compared to the STMSG donor site at week 1.

Conditions

Burns

Keywords

Second Degree Burn Injuries

Outcome Measures

Primary Outcomes (2)

• Incidence of RECELL-treated Area Closure Compared to Control at 4 Weeks (Non-inferiority)

  Recipient site wound closure for both ReCell and STMSG will be defined as the presence of \>=95% epithelialization with contiguous layer of viable epithelium without the need for secondary surgical intervention. Factors considered during the assessment included color, presence of granulation tissue, and whether or not the entire wound is covered with a contiguous layer of viable epithelium. Using this definition, some small degree of punctate blistering was acceptable as long as the wound was \>=95% epithelialized.

  4 weeks

• Incidence of RECELL Donor Site Healing Compared to Control at 1 Week (Superiority)

  Donor site healing will be considered as complete (100%) wound closure if the following criteria were met: an ability to separate the dressing from the wound bed with visible presence over the entirety of the wound of dry, opalescent-pink external surface representing the newly formed outer cornfield layer of the epidermis.

  1 week

Secondary Outcomes (4)

• Percent of Epithelialization at Each Visit Through Week 16

  Each visit through Week 16

• Wound Closure at Week 2 (Based on Investigators Assessment)

  Week 2

• Mean Pain and Appearance Scores at RECELL and Control Recipient Sites (Subject Assessment)

  Pain (Weeks 1-16) and Appearance (Weeks 16-52)

• Mean Pain and Appearance Scores at Donor Sites (Subject Assessment)

  Pain (Weeks 1-16) and Appearance (Weeks 16-52)

Study Arms (1)

all participants

EXPERIMENTAL

All participants will receive both ReCell and split-thickness skin graft

Device: ReCell and Split-thickness skin graft

Interventions

ReCell and Split-thickness skin graft DEVICE

The surgeon will be required to select two similar non-contiguous injury areas with both areas being at least 100cm2 and second degree depth/severity. One area will be treated using ReCell and the second using Split-thickness Skin Graft.

all participants

Eligibility Criteria

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

You may qualify if:

• The subject requires primary skin grafting as a result of an acute thermal burn injury
• The area of the burn injury is at least 200cm2 (1% TBSA in adults) if a contiguous wound, or at least 100cm2 for each of 2 noon-contiguous wounds
• The area of total burn injury is 1-20% TBSA
• The burn injured area can be divided into two treatment areas ( control and treatment) with 100-320cm2 area for each treatment type
• The study treatment area is a second degree burn injury
• The subject is between 18-65 years of age
• The subject is willing to complete all follow-up 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 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
• The subject is able and willing to follow the protocol requirements

You may not qualify if:

• The subject's burn injuries were caused by chemicals, electricity, and/or radioactive substances
• The total subject burn injury is less than 1% or more than 20% TBSA
• The subject has a microbiologically proven pre-existing local or systemic bacterial infection
• The subject has been receiving a systemic antibiotic for more than 48 hours prior to grafting
• The subject is known to have a pre-existing condition that may interfere with wound healing ( e.g. malignancy, diabetes, or autoimmune disease)
• The subject is unable to follow the protocol
• The subject is taking medication known to have an effect on wound healing or skin pigmentation ( e.g. systemic corticosteroids, retinoids, etc)
• 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

Sponsors & Collaborators

• Avita Medical: lead
• United States Department of Defense: collaborator
• Royal Perth Hospital: collaborator
• MedDRA Assistance Inc: collaborator
• BioStat International, Inc.: collaborator

Study Sites (12)

Arizona Burn Center at Maricopa Integrated Health Systems

Phoenix, Arizona, 85008, United States

Location

University of California Davis Regional Burn Center

Sacramento, California, 95817, United States

Location

The Burn Center at Washington Hospital Center

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

Location

Shands Burn Center at University of Florida

Gainesville, Florida, 32610, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Indiana University - Richard M. Fairbanks Burn Center at Wishard Memorial Hospital

Indianapolis, Indiana, 46202, United States

Location

NC Jaycee Burn Center at University of NC at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

University of Tennessee Medical Center

Memphis, Tennessee, 38163, United States

Location

USAISR

Fort Sam Houston, Texas, 78234, United States

Location

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

Virginia Commonwealth University Health System- Evans Haynes Burn Center

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Director of Clinical Research
• Organization: AVITA Medical

clinicaltrial@avitamedical.com

661-367-9170

Study Officials

• James H Holmes, 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2010
• First Posted: June 8, 2010
• Study Start: May 21, 2010
• Primary Completion: August 29, 2014
• Study Completion: August 26, 2015
• Last Updated: May 13, 2019
• Results First Posted: May 13, 2019

Record last verified: 2019-05

Locations

US (12)