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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
  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:


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
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: 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 November 23, 2014