Awbat Versus Biobrane in Partial Thickness Burns (Awbat)

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

• 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®.

Study Overview

• Status: Withdrawn
• Conditions: Burns
• Intervention / Treatment: Device: AWBAT; Device: 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®.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77550
      • Shriners Hospital for Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; AWBAT	Device: AWBAT; One-time application of dressing over partial-thickness burns
ACTIVE_COMPARATOR: 2; BIOBRANE(R)	Device: Biobrane; One-time application over partial-thickness burns

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to complete Healing	5 - 14 days post injury/membrane application

Secondary Outcome Measures

Outcome Measure	Time Frame
Occurence of Infection	entire study period

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Principal Investigator: David N Herndon, MD, Shriners Hospital for Children and University of Texas Medical Branch

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (ANTICIPATED): August 1, 2012
• Study Completion (ANTICIPATED): August 1, 2012

Study Registration Dates

• First Submitted: February 17, 2009
• First Submitted That Met QC Criteria: February 18, 2009
• First Posted (ESTIMATE): February 19, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): December 11, 2012
• Last Update Submitted That Met QC Criteria: December 10, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Partial Thickness burn; Biological Dressing
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: 08-333