Awbat Versus Biobrane in Partial Thickness Burns

Burns Clinical Trial

— Awbat  

Official title:

The Treatment of Partial Thickness Burns: Awbat(r) Versus Biobrane(r)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00847496
• Other study ID #: 08-333
• Status: Withdrawn
• Phase: Phase 2
• First received: February 17, 2009
• Last updated: December 10, 2012
• Start date: December 2009
• Est. completion date: August 2012

Study information

• Verified date: December 2012
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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®.

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®.

Other known NCT identifiers

• NCT00793533

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns

Intervention

Device:
• AWBAT
One-time application of dressing over partial-thickness burns
• Biobrane
One-time application over partial-thickness burns

Locations

Country	Name	City	State
United States	Shriners Hospital for Children	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to complete Healing		5 - 14 days post injury/membrane application	No
Secondary	Occurence of Infection		entire study period	Yes