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

NCT ID: NCT01138917

Last Updated: 2019-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-21
• Study Completion Date: 2015-08-26

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

all participants

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

Group Type: EXPERIMENTAL

ReCell and Split-thickness skin graft

Intervention Type: 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.

Interventions

ReCell and Split-thickness skin graft

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Royal Perth Hospital

OTHER

Sponsor Role: collaborator

MedDRA Assistance Inc

UNKNOWN

Sponsor Role: collaborator

BioStat International, Inc.

INDUSTRY

Sponsor Role: collaborator

Avita Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James H Holmes, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Arizona Burn Center at Maricopa Integrated Health Systems

Phoenix, Arizona, United States

University of California Davis Regional Burn Center

Sacramento, California, United States

The Burn Center at Washington Hospital Center

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

Shands Burn Center at University of Florida

Gainesville, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

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

Indianapolis, Indiana, United States

NC Jaycee Burn Center at University of NC at Chapel Hill

Chapel Hill, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

University of Tennessee Medical Center

Memphis, Tennessee, United States

USAISR

Fort Sam Houston, Texas, United States

Texas Tech University Health Sciences Center

Lubbock, Texas, United States

Virginia Commonwealth University Health System- Evans Haynes Burn Center

Richmond, Virginia, United States

Countries

United States

Other Identifiers

CTP001-5

Identifier Type: -

Identifier Source: org_study_id