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

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ClinicalTrials.gov Identifier: NCT01138917
Recruitment Status : Completed
First Posted : June 8, 2010
Results First Posted : May 13, 2019
Last Update Posted : May 13, 2019
Sponsor:
Collaborators:
United States Department of Defense
Royal Perth Hospital
MedDRA Assistance Inc
BioStat International, Inc.
Information provided by (Responsible Party):
Avita Medical

Tracking Information
First Submitted Date  ICMJE June 3, 2010
First Posted Date  ICMJE June 8, 2010
Results First Submitted Date  ICMJE October 9, 2018
Results First Posted Date  ICMJE May 13, 2019
Last Update Posted Date May 13, 2019
Actual Study Start Date  ICMJE May 21, 2010
Actual Primary Completion Date August 29, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • Incidence of RECELL-treated Area Closure Compared to Control at 4 Weeks (Non-inferiority) [ Time Frame: 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) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 7, 2010)
  • Recipient site wound closure for both ReCell and STMSG [ Time Frame: 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. 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 ]
    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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • Percent of Epithelialization at Each Visit Through Week 16 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2010)
  • Percent of epithelialization of the ReCell and STMSG treated areas [ Time Frame: all follow-up visits up to week 16 ]
    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 ]
    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 ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries
Official Title  ICMJE A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Burns
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: all participants
All participants will receive both ReCell and split-thickness skin graft
Intervention: Device: ReCell and Split-thickness skin graft
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 21, 2018)
101
Original Estimated Enrollment  ICMJE
 (submitted: June 7, 2010)
106
Actual Study Completion Date  ICMJE August 26, 2015
Actual Primary Completion Date August 29, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT01138917
Other Study ID Numbers  ICMJE CTP001-5
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Avita Medical
Study Sponsor  ICMJE Avita Medical
Collaborators  ICMJE
  • United States Department of Defense
  • Royal Perth Hospital
  • MedDRA Assistance Inc
  • BioStat International, Inc.
Investigators  ICMJE
Principal Investigator: James H Holmes, MD Wake Forest University Health Sciences
PRS Account Avita Medical
Verification Date May 2019

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