Back to resultsComparison of AWBAT™-D and MEPILEX® AG for Treatment of Donor Sites in Burn Surgery
Primary Purpose
Burn Surgery
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AWBAT™-D and Mepilex® Ag dressings
Sponsored by
About this trial
This is an interventional treatment trial for Burn Surgery focused on measuring burn, donor site, treatment of burns, Treatment of Donor Sites
Eligibility 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
Sites / Locations
- Doctors Hospital of Augusta
Outcomes
Primary Outcome Measures
Compare rate of healing of donor sites
Secondary Outcome Measures
Compare complication rates
Compare patient reported perception of pain
Compare clinical outcome (scarring)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00974597
Brief Title
Comparison of AWBAT™-D and MEPILEX® AG for Treatment of Donor Sites in Burn Surgery
Official Title
A Randomized, Prospective Comparison of AWBAT™-D and MEPILEX® AG for Treatment of Donor Sites in Burn Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Terminated
Why Stopped
Management Decision
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2010 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Aubrey Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Surgery
Keywords
burn, donor site, treatment of burns, Treatment of Donor Sites
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
AWBAT™-D and Mepilex® Ag dressings
Intervention Description
Comparison of AWBAT™-D and Mepilex® Ag dressings for treatment of donor sites in burn surgery.
Primary Outcome Measure Information:
Title
Compare rate of healing of donor sites
Time Frame
6 month follow-up
Secondary Outcome Measure Information:
Title
Compare complication rates
Time Frame
6 month follow-up
Title
Compare patient reported perception of pain
Time Frame
6 month follow-up
Title
Compare clinical outcome (scarring)
Time Frame
6 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Doctors Hospital of Augusta
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of AWBAT™-D and MEPILEX® AG for Treatment of Donor Sites in Burn Surgery
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