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

Not Applicable

Completed

Conditions: Burns

Interventions: Device: ReCell and Split-thickness skin graft

Registration Number: NCT01138917

Lead Sponsor: Avita Medical

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 101

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
all participants	ReCell and Split-thickness skin graft	All participants will receive both ReCell and split-thickness skin graft

Primary Outcome Measures

Name	Time	Method
Incidence of RECELL-treated Area Closure Compared to Control at 4 Weeks (Non-inferiority)	4 weeks	Recipient site wound closure for both ReCell and STMSG will be defined as the presence of \>=95% epithelialization with contiguous layer of viable epithelium without the need for secondary surgical intervention. Factors considered during the assessment included color, presence of granulation tissue, and whether or not the entire wound is covered with a contiguous layer of viable epithelium. Using this definition, some small degree of punctate blistering was acceptable as long as the wound was \>=95% epithelialized.
Incidence of RECELL Donor Site Healing Compared to Control at 1 Week (Superiority)	1 week	Donor site healing will be considered as complete (100%) wound closure if the following criteria were met: an ability to separate the dressing from the wound bed with visible presence over the entirety of the wound of dry, opalescent-pink external surface representing the newly formed outer cornfield layer of the epidermis.

Secondary Outcome Measures

Name	Time	Method
Percent of Epithelialization at Each Visit Through Week 16	Each visit through Week 16	The percent epithelialization of the RECELL and Control treated sites will be assessed using standardized planimetry/tracing procedures. The tracings were uploaded to a Central Reading Facility for calculation of percent epithelialization using a computerized measurement technique.
Wound Closure at Week 2 (Based on Investigators Assessment)	Week 2	The proportion of recipient sites achieving wound closure at Week 2 was evaluated using the Investigators assessment of wound healing.
Mean Pain and Appearance Scores at RECELL and Control Recipient Sites (Subject Assessment)	Pain (Weeks 1-16) and Appearance (Weeks 16-52)	Subject assessment of pain at the RECELL and Control recipient sites was performed at all study follow-up visits up to Week 16. Subjects also assessed the satisfaction with the appearance of the treatment sites at the Week 16, 24, and 52 study follow-up visits. The subject assessments were performed using VAS (visual analogue scale) style questionnaires. Pain VAS 0-100 where 0=non-existent pain and 100=severe pain. Appearance VAS 0-100 where 0=terrible and 100=exceptional
Mean Pain and Appearance Scores at Donor Sites (Subject Assessment)	Pain (Weeks 1-16) and Appearance (Weeks 16-52)	Subject assessment of pain at the RECELL and Control donor sites was performed at all study follow-up visits up to Week 16. Subjects also assessed the satisfaction with the appearance of the donor sites at the Week 16, 24, and 52 study follow-up visits. The subject assessments were performed using VAS (visual analogue scale) style questionnaires. Pain VAS 0-100 where 0=non-existent pain and 100=severe pain. Appearance VAS 0-100 where 0=terrible and 100=exceptional.

Trial Locations

Locations (12): Arizona Burn Center at Maricopa Integrated Health Systems
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Phoenix, Arizona, United States
University of California Davis Regional Burn Center
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Sacramento, California, United States
Shands Burn Center at University of Florida
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Gainesville, Florida, United States
The Burn Center at Washington Hospital Center
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Washington, District of Columbia, United States
Tampa General Hospital
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Tampa, Florida, United States
Indiana University - Richard M. Fairbanks Burn Center at Wishard Memorial Hospital
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Indianapolis, Indiana, United States
NC Jaycee Burn Center at University of NC at Chapel Hill
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Chapel Hill, North Carolina, United States
USAISR
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Fort Sam Houston, Texas, United States
University of Tennessee Medical Center
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Memphis, Tennessee, United States
Texas Tech University Health Sciences Center
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Lubbock, Texas, United States
Virginia Commonwealth University Health System- Evans Haynes Burn Center
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Richmond, Virginia, United States
Wake Forest University Health Sciences
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Winston-Salem, North Carolina, United States