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Awbat Versus Biobrane in Partial Thickness Burns (Awbat)

Primary Purpose

Burns

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AWBAT
Biobrane
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring Partial Thickness burn, Biological Dressing

Eligibility Criteria

3 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Partial thickness burns between 4% and 40% Total Body Surface Area(TBSA)
  • Full thickness burns not to exceed 10% TBSA,
  • Age as specified

Exclusion Criteria:

  • Full thickness burns that require immediate excision and grafting
  • Known allergic reaction against Biobrane
  • Chemical and electrical burns

Sites / Locations

  • Shriners Hospital for Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

AWBAT

BIOBRANE(R)

Outcomes

Primary Outcome Measures

Time to complete Healing

Secondary Outcome Measures

Occurence of Infection

Full Information

First Posted
February 17, 2009
Last Updated
December 10, 2012
Sponsor
The University of Texas Medical Branch, Galveston
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1. Study Identification

Unique Protocol Identification Number
NCT00847496
Brief Title
Awbat Versus Biobrane in Partial Thickness Burns
Acronym
Awbat
Official Title
The Treatment of Partial Thickness Burns: Awbat(r) Versus Biobrane(r)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Company went out of business
Study Start Date
December 2009 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
August 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
• To determine if AWBAT, used in treating partial-thickness burns, would provide better healing, pain control, control of infection, shorter length of hospital stay, lower costs, and improved scarring and long term recovery when compared to Biobrane®.
Detailed Description
Currently there is no "best covering" or a standard "approved care" for treating partial thickness burns. Several options are available; however, they all have shortcomings. The application of topical antimicrobial dressings is time consuming and the regular dressing changes often associated with pain. Homograft or cadaver skin is often unavailable or in great shortage for skin transplants. Biobrane®, a biosynthetic wound dressing constructed of a silicone film with a nylon fabric partially imbedded into the film, has been available and used at our institute for many years as a skin substitute. It has been shown to reduce pain and the number of necessary dressing changes, and significantly reduced healing time (1). Its main side effects, although rare, are the occasional occurrence of infections and allergic reactions to the material. Recently, a new product, AWBAT, has been developed for the coverage of partial thickness burns. AWBAT is similar to Biobrane® in terms of silicone membrane thickness, the structure of nylon fabric that gives the dermal substitute its strength, and the use of collagen peptides on the inner side of the membrane. These peptides are used for the purpose of reacting with the fibrin in the wound in order to achieve good initial adherence and to accelerate re-epithelialization. The key novelties of AWBAT are the different pore size and modality of collagen peptide attachments. These two key modifications aim at a reduction of the above mentioned adverse reactions. The purpose of this study is to compare AWBAT to Biobrane® for covering partial thickness-burn injuries. We wish to determine if AWBAT, used in treating partial-thickness burns, would provide better healing, pain control, control of infection, shorter length of hospital stay, and improved scarring and long term recovery when compared to Biobrane®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
Partial Thickness burn, Biological Dressing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
AWBAT
Arm Title
2
Arm Type
Active Comparator
Arm Description
BIOBRANE(R)
Intervention Type
Device
Intervention Name(s)
AWBAT
Intervention Description
One-time application of dressing over partial-thickness burns
Intervention Type
Device
Intervention Name(s)
Biobrane
Intervention Description
One-time application over partial-thickness burns
Primary Outcome Measure Information:
Title
Time to complete Healing
Time Frame
5 - 14 days post injury/membrane application
Secondary Outcome Measure Information:
Title
Occurence of Infection
Time Frame
entire study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Partial thickness burns between 4% and 40% Total Body Surface Area(TBSA) Full thickness burns not to exceed 10% TBSA, Age as specified Exclusion Criteria: Full thickness burns that require immediate excision and grafting Known allergic reaction against Biobrane Chemical and electrical burns
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David N Herndon, MD
Organizational Affiliation
Shriners Hospital for Children and University of Texas Medical Branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shriners Hospital for Children
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States

12. IPD Sharing Statement

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Awbat Versus Biobrane in Partial Thickness Burns

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