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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)

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ClinicalTrials.gov Identifier: NCT00964470
Recruitment Status : Unknown
Verified September 2009 by Aubrey Inc..
Recruitment status was:  Recruiting
First Posted : August 25, 2009
Last Update Posted : June 22, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Treatment of Donor Site Burns Device: AWBAT™-D and XEROFORM™ OR GLUCAN II™ 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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2009
Estimated Primary Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. • 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 ]

Secondary Outcome Measures :
  1. • To compare clinical outcome of donor sites: scarring based on the Vancouver Scar Scale. [ Time Frame: 2 year follow-up ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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

Responsible Party: Stephen Moss/President, Aubrey Inc.
ClinicalTrials.gov Identifier: NCT00964470     History of Changes
Other Study ID Numbers: #AW-101008MC-DS
First Posted: August 25, 2009    Key Record Dates
Last Update Posted: June 22, 2010
Last Verified: September 2009

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

Additional relevant MeSH terms:
Burns
Wounds and Injuries