Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

August 23, 2009
June 21, 2010
August 2009
December 2010   (final data collection date for primary outcome measure)
• 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 ]
Same as current
Complete list of historical versions of study NCT00964470 on ClinicalTrials.gov Archive Site
• 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 ]
Same as current
Not Provided
Not Provided
 
Multi-Center, Prospective, Randomized, Comparison of AWBAT™-D vs. Xeroform™ or Glucan II™ for Treatment of Donor Sites in Burn Surgery
Multi-Center, Prospective, Randomized, Comparison of AWBAT™-D vs. Xeroform™ or Glucan II™ for Treatment of Donor Sites in Burn Surgery

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Treatment of Donor Site Burns
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Not Provided
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact: Steven Moss 760-602-8300 smoss@aubreyinc.com
Contact: Tara Cordova 760-602-8300 tcordova@aubreyinc.com
United States
 
NCT00964470
#AW-101008MC-DS
No
Stephen Moss/President, Aubrey Inc.
Aubrey Inc.
Not Provided
Not Provided
Aubrey Inc.
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP