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WithdrawnNCT00847496AwbatUpdated Dec 11, 2012

Awbat Versus Biobrane in Partial Thickness Burns

A Phase 2 interventional study of AWBAT and Biobrane in Burns, sponsored by The University of Texas Medical Branch, Galveston. Withdrawn at 1 site in United States. Open to participants aged 3 Months to 18 Years. Per ClinicalTrials.gov, last updated 2012-12-11.

Sponsored by The University of Texas Medical Branch, Galveston · Phase 2, Interventional, and Treatment

Why this study was withdrawn
Company went out of business
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
3 Months to 18 Years
Sex
All
01

Study 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®.
Read the 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®.

02

Conditions studied

  • Burns

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Keywords

  • Partial Thickness burn
  • Biological Dressing
03

In context

Burns

719 studies on the registry are indexed under Burns; 145 are open to participants now.

Browse Burns studies →

Lead sponsor

The University of Texas Medical Branch, Galveston is the lead sponsor of 251 studies on the registry; 38 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Months to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Full thickness burns that require immediate excision and grafting
  • Known allergic reaction against Biobrane
  • Chemical and electrical burns
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    1

    AWBAT

    Device: AWBAT

  • Active comparator
    2

    BIOBRANE(R)

    Device: Biobrane

Interventions

  • DeviceAWBAT

    One-time application of dressing over partial-thickness burns

  • DeviceBiobrane

    One-time application over partial-thickness burns

06

What researchers measure

Primary outcomes

  1. Time to complete Healing

    Time frame: 5 - 14 days post injury/membrane application

Secondary outcomes

  1. Occurence of Infection

    Time frame: entire study period

07

Study locations

1 site
  • Shriners Hospital for Children
    Galveston, Texas 77550, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00847496
Lead sponsor
The University of Texas Medical Branch, Galveston
Responsible party
Sponsor
First posted
Feb 19, 2009
Start date
Dec 2009
Primary completion
Aug 2012 (estimated)
Completion
Aug 2012 (estimated)
Last update
Dec 11, 2012

Study contacts

David N Herndon, MD
principal investigator · Shriners Hospital for Children and University of Texas Medical Branch

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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