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

Comparison of AWBAT™-D and MEPILEX® AG for Treatment of Donor Sites in Burn Surgery

This study has been terminated.
(Management Decision)
Sponsor:
Information provided by:
Aubrey Inc.
ClinicalTrials.gov Identifier:
NCT00974597
First received: September 8, 2009
Last updated: June 21, 2010
Last verified: December 2009

September 8, 2009
June 21, 2010
September 2009
September 2010   (final data collection date for primary outcome measure)
Compare rate of healing of donor sites [ Time Frame: 6 month follow-up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00974597 on ClinicalTrials.gov Archive Site
  • Compare complication rates [ Time Frame: 6 month follow-up ] [ Designated as safety issue: No ]
  • Compare patient reported perception of pain [ Time Frame: 6 month follow-up ] [ Designated as safety issue: No ]
  • Compare clinical outcome (scarring) [ Time Frame: 6 month follow-up ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of AWBAT™-D and MEPILEX® AG for Treatment of Donor Sites in Burn Surgery
A Randomized, Prospective Comparison of AWBAT™-D and MEPILEX® AG for Treatment of Donor Sites in Burn Surgery

The purpose of this study is to examine AWBAT™-D compared to Mepilex® Ag for the treatment of donor sites in burn surgery.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Burn Surgery
Device: AWBAT™-D and Mepilex® Ag dressings
Comparison of AWBAT™-D and Mepilex® Ag dressings for treatment of donor sites in burn surgery.
Other Name: AWBAT™-D and Mepilex® Ag 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.
 
Terminated
30
Not Provided
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Burn wounds requiring skin grafting
  • Matched donor sites available
  • 1-30% TBSA

Exclusion Criteria:

  • Severe inhalation injury
  • Pregnancy
  • Co-morbidity which may compromise healing
  • Known allergy to pork or pork products
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00974597
#AW-101008DS
No
Stephen Moss/President, Aubrey Inc.
Aubrey Inc.
Not Provided
Not Provided
Aubrey Inc.
December 2009

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