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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
History of Changes
  Purpose

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


Condition Intervention
Burn Surgery
 Device: AWBAT™-D and Mepilex® Ag dressings

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Prospective Comparison of AWBAT™-D and MEPILEX® AG for Treatment of Donor Sites in Burn Surgery

Resource links provided by NLM:

MedlinePlus related topics: Burns
U.S. FDA Resources

Further study details as provided by Aubrey Inc.:

Primary Outcome Measures:
  • Compare rate of healing of donor sites [ Time Frame: 6 month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: September 2009
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00974597

Locations
United States, Georgia
Doctors Hospital of Augusta
Augusta, Georgia, United States, 30909
Sponsors and Collaborators
Aubrey Inc.
  More Information

No publications provided

Responsible Party: Stephen Moss/President, Aubrey Inc.
ClinicalTrials.gov Identifier: NCT00974597     History of Changes
Other Study ID Numbers: #AW-101008DS
Study First Received: September 8, 2009
Last Updated: June 21, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Aubrey Inc.:
burn
donor site
treatment of burns
Treatment of Donor Sites

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on May 22, 2013