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

This study is currently recruiting participants.
Verified November 2012 by Avita Medical
Sponsor:
Collaborators:
Royal Perth Hospital
MedDRA Assistance Inc
BioStat International, Inc.
Information provided by (Responsible Party):
Avita Medical
ClinicalTrials.gov Identifier:
NCT01138917
First received: June 3, 2010
Last updated: November 28, 2012
Last verified: November 2012

June 3, 2010
November 28, 2012
June 2010
July 2013   (final data collection date for primary outcome measure)
  • Recipient site wound closure for both ReCell and STMSG [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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. The outcomes of the recipient site wound closure will be documented photographically using standardized digital photographic techniques and will be transferred to a Central Reading Facility to be reviewed by qualified Independent Clinical Experts. Avita Medical expects that the wound closure of the ReCell treated recipient sites will be no worse than that obtained using STMSG.
  • Superiority of the ReCell donor site healing as compared to STMSG donor site [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Donor site healing will be considered as complete (100%) wound closure, defined as the ability to separate the dressing from the wound bed and the visible presence over the entirety of the wound of dry, opalescent-pink external surface of the newly formed outer layer of the epidermis. The outcomes of wound closure will be documented using standardized photographic techniques and will be transferred to a Central Reading Facility to be reviewed by qualified Independent Clinical Experts. Avita Medical expects the wound closure of the ReCell donor sites will be superior to the STMSG donor site.
Same as current
Complete list of historical versions of study NCT01138917 on ClinicalTrials.gov Archive Site
  • Percent of epithelialization of the ReCell and STMSG treated areas [ Time Frame: all follow-up visits up to week 16 ] [ Designated as safety issue: No ]
    The percent epithelialization of the ReCell and STMSG treated areas will be assessed using standardized planimetry/tracing procedures and will be forwarded to the Central Reading Facility for calculation using a computerized measurement technique.
  • recipient site wound closure [ Time Frame: week 2 ] [ Designated as safety issue: No ]
    The recipient site wound closure at week 2 will be evaluated using Investigators assessment of wound healing
  • Pain and appearance at the ReCell and STMSG treatment areas and at donor sites [ Time Frame: all follow up visits up to week 16 ] [ Designated as safety issue: No ]
    Subject assessment of pain at the ReCell and STMSG treatment and donor sites will be performed at all study follow-up visits up to week 16. The subject assessments will be performed using VAS ( visual analogue scale) style questionnaires.
Same as current
Not Provided
Not Provided
 
A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries
A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Burns
Device: ReCell and Split-thickness skin graft
The surgeon will be required to select two similar non-contiguous injury areas with both areas being at least 100cm2 and second degree depth/severity. One area will be treated using ReCell and the second using Split-thickness Skin Graft.
Experimental: all participants
All participants will receive both ReCell and split-thickness skin graft
Intervention: Device: ReCell and Split-thickness skin graft
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
106
March 2014
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Drina Aldana 818 3569400 daldana@avitamedical.com
Contact: Andrew Quick 818 3569400 aquick@avitamedical.com
United States,   Canada
 
NCT01138917
CTP001-5
Yes
Avita Medical
Avita Medical
  • Department of Defense
  • Royal Perth Hospital
  • MedDRA Assistance Inc
  • BioStat International, Inc.
Principal Investigator: James H Holmes, MD Wake Forest School of Medicine
Avita Medical
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP