Status:
COMPLETED
A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries
Lead Sponsor:
Avita Medical
Collaborating Sponsors:
United States Department of Defense
Royal Perth Hospital
Conditions:
Burns
Eligibility:
All Genders
18-65 years
Phase:
NA
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 21 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2015
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT01138917
Start Date
May 21 2010
End Date
August 26 2015
Last Update
May 13 2019
Active Locations (12)
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1
Arizona Burn Center at Maricopa Integrated Health Systems
Phoenix, Arizona, United States, 85008
2
University of California Davis Regional Burn Center
Sacramento, California, United States, 95817
3
The Burn Center at Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
4
Shands Burn Center at University of Florida
Gainesville, Florida, United States, 32610