Back to resultsA Postmarket Randomized Study of the Treatment of Superficial Partial-Thickness Burns Using Two Dressings
Primary Purpose
Burns
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AWBAT Wound Dressing
AWBAT™, Biobrane®
Sponsored by
About this trial
This is an interventional treatment trial for Burns focused on measuring Burn, Superficial burns, Partial thickness burns, Rate of healing, Infection rate, Pain perception, Non adherence, Scarring
Eligibility Criteria
Inclusion Criteria:
- Superficial partial thickness burns
- Two non-contiguous burn sites or the same approximate size/depth for comparison, OR
- One burn site large enough to accommodate both a 6" square AWBAT™ dressing and a 6 " square Biobrane® dressing
- Burn wounds measuring >2% - <40% TBSA
- Patient age: >1 - 70 years
Exclusion Criteria:
- Ventilator dependence
- Pregnancy/Lactation
- Mechanism of injury was electrical, chemical or frostbite
- Co-morbidity which may compromise healing
- Known allergy to porcine or porcine products
Sites / Locations
- UC Irvine Burn Center
- University of Missouri Health Care
- Shriners Hospitals for Children
Outcomes
Primary Outcome Measures
Rate of healing
Secondary Outcome Measures
Scarring
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01067729
Brief Title
A Postmarket Randomized Study of the Treatment of Superficial Partial-Thickness Burns Using Two Dressings
Official Title
A Multi-Center, Randomized, Prospective Study of the Treatment of Superficial Partial-Thickness Burns: AWBAT™ vs. Biobrane®
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Terminated
Study Start Date
November 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
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 research study is to compare the rate of healing, the infection or complication rate, pain perception and scarring from burn injuries using two types of burn dressings.
Detailed Description
The purpose of this study is to evaluate AWBAT™ compared to Biobrane® for the treatment of superficial partial-thickness burns using the patient as their own control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
Burn, Superficial burns, Partial thickness burns, Rate of healing, Infection rate, Pain perception, Non adherence, Scarring
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
AWBAT Wound Dressing
Other Intervention Name(s)
Biobrane
Intervention Type
Device
Intervention Name(s)
AWBAT™, Biobrane®
Intervention Description
Comparison of burn dressings on randomized body sites using patient as own control
Primary Outcome Measure Information:
Title
Rate of healing
Time Frame
Day 14
Secondary Outcome Measure Information:
Title
Scarring
Time Frame
6 months, 1 year, 18 months and 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Superficial partial thickness burns
Two non-contiguous burn sites or the same approximate size/depth for comparison, OR
One burn site large enough to accommodate both a 6" square AWBAT™ dressing and a 6 " square Biobrane® dressing
Burn wounds measuring >2% - <40% TBSA
Patient age: >1 - 70 years
Exclusion Criteria:
Ventilator dependence
Pregnancy/Lactation
Mechanism of injury was electrical, chemical or frostbite
Co-morbidity which may compromise healing
Known allergy to porcine or porcine products
Facility Information:
Facility Name
UC Irvine Burn Center
City
Irvine
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of Missouri Health Care
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Shriners Hospitals for Children
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Postmarket Randomized Study of the Treatment of Superficial Partial-Thickness Burns Using Two Dressings
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