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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by Avita Medical.
Recruitment status was  Recruiting
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
  Purpose

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 Intervention
Burns
Device: ReCell and Split-thickness skin graft

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Avita Medical:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 106
Study Start Date: June 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01138917

Contacts
Contact: Drina Aldana 818 3569400 daldana@avitamedical.com
Contact: Andrew Quick 818 3569400 aquick@avitamedical.com

Locations
United States, Arizona
Arizona Burn Center at Maricopa Integrated Health Systems Recruiting
Phoenix, Arizona, United States, 85008
Contact: Karen Richey, RN    602-344-5125    karen.richey@hcs.maricopa.gov   
Principal Investigator: Kevin Foster, MD, MBA,FACS         
United States, California
University of California Davis Regional Burn Center Recruiting
Sacramento, California, United States, 95817
Contact: Carol Kinkennon, RN    916-453-2136    carol.kinkennon@ucdmc.ucdavis.edu   
Principal Investigator: Tina L. Palmieri, MD         
United States, District of Columbia
The Burn Center at Washington Hospital Center Active, not recruiting
Washington, District of Columbia, United States, 20010
United States, Florida
Shands Burn Center at University of Florida Active, not recruiting
Gainesville, Florida, United States, 32610
Orlando Regional Medical Center Withdrawn
Orlando, Florida, United States, 32806
Tampa General Hospital Active, not recruiting
Tampa, Florida, United States, 33606
United States, Illinois
Loyola University Medical Center Withdrawn
Maywood, Illinois, United States, 60153
United States, Indiana
Indiana University - Richard M. Fairbanks Burn Center at Wishard Memorial Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: David Roggy    317-630-6399    david.roggy@wishard.edu   
Principal Investigator: Rajiv Sood, MD         
United States, North Carolina
NC Jaycee Burn Center at University of NC at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Carrie Nielsen    919-843-8842    carrie.nielsen@med.unc.edu   
Principal Investigator: Bruce A Cairns, MD         
Wake Forest University Health Sciences Active, not recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Tennessee
University of Tennessee Medical Center Recruiting
Memphis, Tennessee, United States, 38163
Contact: Angela Arnold-Ross, RN    901-834-5834    aarnoldr@uthsc.edu   
Principal Investigator: William Hickerson, MD, FACS         
United States, Texas
USAISR Recruiting
Fort Sam Houston, Texas, United States, 78234
Contact: Bryan Jordan    210-916-7154    Bryan.Stephen.Jordan@us.army.mil   
Principal Investigator: Booker King, M.D.         
Texas Tech University Health Sciences Center Active, not recruiting
Lubbock, Texas, United States, 79430
United States, Virginia
Virginia Commonwealth University Health System- Evans Haynes Burn Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Valentina Lucas, ANP    804-828-3049      
Contact: , MD         
Principal Investigator: Feldman Michael, MD         
Principal Investigator: Andrea Pozez, MD         
United States, Washington
UW Regional Burn Center at Harborview Medical Center Withdrawn
Seattle, Washington, United States, 359796
Canada, Ontario
Sunnybrook Health Sciences Centre (Ross Tilley Burn Ctr) Not yet recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Marjorie Burnett    416-480-6100 ext 88021    marjorie.burnett@sunnybrook.ca   
Principal Investigator: Marc Jeschke, MD         
Sponsors and Collaborators
Avita Medical
Royal Perth Hospital
MedDRA Assistance Inc
BioStat International, Inc.
Investigators
Principal Investigator: James H Holmes, MD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Avita Medical
ClinicalTrials.gov Identifier: NCT01138917     History of Changes
Other Study ID Numbers: CTP001-5
Study First Received: June 3, 2010
Last Updated: November 28, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Avita Medical:
Second Degree Burn Injuries

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on November 20, 2014