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

Completed · Not applicable

Conditions studied: Burns

In brief

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.

Key facts

Study ID

NCT01138917

Run by

Avita Medical

People needed

101

Starts

2010-05-21

Expected to finish

2015-08-26

Last updated by the study team

2019-05-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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