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

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

sites

Tampa General Hospital

1 Tampa General Cir
Tampa, Florida 33606

(813) 844-7000