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

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ClinicalTrials.gov Identifier: NCT00974597
Recruitment Status : Terminated (Management Decision)
First Posted : September 10, 2009
Last Update Posted : June 22, 2010
Sponsor:
Information provided by:
Aubrey Inc.

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

Condition or disease Intervention/treatment Phase
Burn Surgery Device: AWBAT™-D and Mepilex® Ag dressings Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2009
Estimated Primary Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns


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.


Primary Outcome Measures :
  1. Compare rate of healing of donor sites [ Time Frame: 6 month follow-up ]

Secondary Outcome Measures :
  1. Compare complication rates [ Time Frame: 6 month follow-up ]
  2. Compare patient reported perception of pain [ Time Frame: 6 month follow-up ]
  3. Compare clinical outcome (scarring) [ Time Frame: 6 month follow-up ]


Information from the National Library of Medicine

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

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): NCT00974597


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

Responsible Party: Stephen Moss/President, Aubrey Inc.
ClinicalTrials.gov Identifier: NCT00974597     History of Changes
Other Study ID Numbers: #AW-101008DS
First Posted: September 10, 2009    Key Record Dates
Last Update Posted: June 22, 2010
Last Verified: December 2009

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

Additional relevant MeSH terms:
Burns
Wounds and Injuries