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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

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.

Condition or disease Intervention/treatment Phase
Burns Device: ReCell and Split-thickness skin graft Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries
Actual Study Start Date : May 21, 2010
Actual Primary Completion Date : August 29, 2014
Actual Study Completion Date : August 26, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
Experimental: all participants
All participants will receive both ReCell and split-thickness skin graft
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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


  4. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01138917


Locations
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United States, Arizona
Arizona Burn Center at Maricopa Integrated Health Systems
Phoenix, Arizona, United States, 85008
United States, California
University of California Davis Regional Burn Center
Sacramento, California, United States, 95817
United States, District of Columbia
The Burn Center at Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Shands Burn Center at University of Florida
Gainesville, Florida, United States, 32610
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Indiana
Indiana University - Richard M. Fairbanks Burn Center at Wishard Memorial Hospital
Indianapolis, Indiana, United States, 46202
United States, North Carolina
NC Jaycee Burn Center at University of NC at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Tennessee
University of Tennessee Medical Center
Memphis, Tennessee, United States, 38163
United States, Texas
USAISR
Fort Sam Houston, Texas, United States, 78234
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430
United States, Virginia
Virginia Commonwealth University Health System- Evans Haynes Burn Center
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Avita Medical
United States Department of Defense
Royal Perth Hospital
MedDRA Assistance Inc
BioStat International, Inc.
Investigators
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Principal Investigator: James H Holmes, MD Wake Forest University Health Sciences
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Responsible Party: Avita Medical
ClinicalTrials.gov Identifier: NCT01138917    
Other Study ID Numbers: CTP001-5
First Posted: June 8, 2010    Key Record Dates
Results First Posted: May 13, 2019
Last Update Posted: May 13, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Avita Medical:
Second Degree Burn Injuries
Additional relevant MeSH terms:
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Burns
Wounds and Injuries