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

The Burn Center at Washington Hospital Center

Washington, District of Columbia 20010

2322

from 98109

Washington,