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Multi-Center, Prospective, Randomized, Comparison of AWBAT™-D vs. Xeroform™ or Glucan II™ for Treatment of Donor Sites in Burn Surgery (AWBAT-D)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Aubrey Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Aubrey Inc.
ClinicalTrials.gov Identifier:
NCT00964470
First received: August 23, 2009
Last updated: June 21, 2010
Last verified: September 2009
History of Changes
  Purpose

The purpose of this study is to compare the rate of healing and the non-adherence of three types of dressings. The study will also compare rate of infection, scarring and perception of pain associated with treatment.


Condition Intervention
Treatment of Donor Site Burns
 Device: AWBAT™-D and XEROFORM™ OR GLUCAN II™ dressings

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-Center, Prospective, Randomized, Comparison of AWBAT™-D vs. Xeroform™ or Glucan II™ for Treatment of Donor Sites in Burn Surgery

Resource links provided by NLM:

MedlinePlus related topics: Burns Scars
U.S. FDA Resources

Further study details as provided by Aubrey Inc.:

Primary Outcome Measures:
  • • To compare the rate of healing of donor sites. • To compare patient reported perception of pain • To compare the potential clinical complication rates of: o non-adherence, o seroma o hematoma o infection [ Time Frame: 2 year follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • To compare clinical outcome of donor sites: scarring based on the Vancouver Scar Scale. [ Time Frame: 2 year follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2009
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: AWBAT™-D and XEROFORM™ OR GLUCAN II™ dressings
    Dressing, donor site dressings
    Other Name: AWBAT™-D and XEROFORM™ OR GLUCAN II™ donor site dressings
Detailed Description:

The purpose of this study is to evaluate AWBAT™-D compared to Xeroform™ or Glucan II™ for the treatment of donor sites in burn surgery.

Primary Study Goals:

  • To compare the rate of healing of donor sites.
  • To compare patient reported perception of pain

  • To compare the potential clinical complication rates of:

    • non-adherence,
    • seroma
    • hematoma
    • infection

Secondary Study Goal:

• To compare clinical outcome of donor sites: scarring based on the Vancouver Scar Scale.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Burn wounds measuring 1% - 30% TBSA requiring skin grafting
  • Anterior bilateral donor sites of approximately the same size taken from the thighs or abdomen

Exclusion Criteria:

  • Ventilator dependence
  • Pregnancy /Lactation
  • Mechanism of injury was electrical, chemical or frostbite
  • Co-morbidity which may compromise healing
  • Known allergy to porcine or porcine products
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00964470

Contacts
Contact: Steven Moss 760-602-8300 smoss@aubreyinc.com
Contact: Tara Cordova 760-602-8300 tcordova@aubreyinc.com

Locations
United States, Indiana
Wishard Health Services Burn Center Recruiting
Indianapolis, Indiana, United States, 46204
Contact: Rajiv Sood, MD     317-278-1022     rsood@iupui.edu    
Principal Investigator: Rajiv Sood, MD            
United States, Ohio
The University Hospital Burn Center Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219
Contact: J. Kevin Bailey, MD     513-558-4361     baileyj4@ucmail.uc.edu    
Contact: Rich Branson, MD     513-558-6785     richard.branson@uc.edu    
United States, Tennessee
Firefighter's Regional Burn Center Recruiting
Memphis, Tennessee, United States, 38103
Contact: William Hickerson, MD     901-448-2579     bhickerson@mac.com    
Contact: Lisa K Mason-Sutton, BSN     901-448-2525     lmasonsu@utmem.edu    
Sponsors and Collaborators
Aubrey Inc.
  More Information

No publications provided

Responsible Party: Stephen Moss/President, Aubrey Inc.
ClinicalTrials.gov Identifier: NCT00964470     History of Changes
Other Study ID Numbers: #AW-101008MC-DS
Study First Received: August 23, 2009
Last Updated: June 21, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Aubrey Inc.:
Burn, donor site, skin graft, dressing, AWBAT™-D, XEROFORM™, GLUCAN II™

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013