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



Status:Completed
Conditions:Other Indications, Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 65
Updated:9/27/2018
Start Date:May 21, 2010
End Date:August 26, 2015

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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.


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
We found this trial at
12
sites
1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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Chapel Hill, NC
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Fort Sam Houston, Texas 78234
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Gainesville, Florida 32610
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Indianapolis, IN
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Lubbock, TX
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Memphis, Tennessee 38163
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Phoenix, AZ
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Richmond, VA
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Sacramento, CA
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Washington, District of Columbia 20010
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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Winston-Salem, NC
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