Clinical trial NCT01138917: A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries
Official title: A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Keywords: Second Degree Burn Injuries
Lead sponsor: Avita Medical
Sponsor class: INDUSTRY
Collaborators: name: United States Department of Defense
name: Royal Perth Hospital
name: MedDRA Assistance Inc
name: BioStat International, Inc.
First posted: 2010-06-08
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of RECELL-treated Area Closure Compared to Control at 4 Weeks (Non-inferiority)
timeFrame: 4 weeks
measure: Incidence of RECELL Donor Site Healing Compared to Control at 1 Week (Superiority)
timeFrame: 1 week
Secondary outcomes:
measure: Percent of Epithelialization at Each Visit Through Week 16
timeFrame: Each visit through Week 16
measure: Wound Closure at Week 2 (Based on Investigators Assessment)
timeFrame: Week 2
measure: Mean Pain and Appearance Scores at RECELL and Control Recipient Sites (Subject Assessment)
timeFrame: Pain (Weeks 1-16) and Appearance (Weeks 16-52)
measure: Mean Pain and Appearance Scores at Donor Sites (Subject Assessment)
timeFrame: Pain (Weeks 1-16) and Appearance (Weeks 16-52)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Burn Center at Maricopa Integrated Health Systems
state: Arizona
city: Sacramento
country: United States
facility: University of California Davis Regional Burn Center
state: California
city: Washington
country: United States
facility: The Burn Center at Washington Hospital Center
state: District of Columbia
city: Gainesville
country: United States
facility: Shands Burn Center at University of Florida
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Indianapolis
country: United States
facility: Indiana University - Richard M. Fairbanks Burn Center at Wishard Memorial Hospital
state: Indiana
city: Chapel Hill
country: United States
facility: NC Jaycee Burn Center at University of NC at Chapel Hill
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Memphis
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Fort Sam Houston
country: United States
facility: USAISR
state: Texas
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University Health System- Evans Haynes Burn Center
state: Virginia
Study officials:
affiliation: Wake Forest University Health Sciences
name: James H Holmes, MD
role: PRINCIPAL_INVESTIGATOR
References: