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
  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:


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
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: 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 August 26, 2014