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Awbat Versus Biobrane in Partial Thickness Burns

NCT ID: NCT00847496

Last Updated: 2012-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2012-08-31

Brief Summary

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• 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

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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®.

Conditions

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Burns

Keywords

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Partial Thickness burn Biological Dressing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

AWBAT

Group Type EXPERIMENTAL

AWBAT

Intervention Type DEVICE

One-time application of dressing over partial-thickness burns

2

BIOBRANE(R)

Group Type ACTIVE_COMPARATOR

Biobrane

Intervention Type DEVICE

One-time application over partial-thickness burns

Interventions

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AWBAT

One-time application of dressing over partial-thickness burns

Intervention Type DEVICE

Biobrane

One-time application over partial-thickness burns

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

3 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David N Herndon, MD

Role: PRINCIPAL_INVESTIGATOR

Shriners Hospital for Children and University of Texas Medical Branch

Locations

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Shriners Hospital for Children

Galveston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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08-333

Identifier Type: -

Identifier Source: org_study_id

NCT00793533

Identifier Type: -

Identifier Source: nct_alias