A Postmarket Randomized Study of the Treatment of Superficial Partial-Thickness Burns Using Two Dressings

January 23, 2015 updated by: Aubrey Inc.

A Multi-Center, Randomized, Prospective Study of the Treatment of Superficial Partial-Thickness Burns: AWBAT™ vs. Biobrane®

The purpose of this research study is to compare the rate of healing, the infection or complication rate, pain perception and scarring from burn injuries using two types of burn dressings.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to evaluate AWBAT™ compared to Biobrane® for the treatment of superficial partial-thickness burns using the patient as their own control.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92868
        • UC Irvine Burn Center
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri Health Care
    • Texas
      • Galveston, Texas, United States, 77550
        • Shriners Hospitals for Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Superficial partial thickness burns
  • Two non-contiguous burn sites or the same approximate size/depth for comparison, OR
  • One burn site large enough to accommodate both a 6" square AWBAT™ dressing and a 6 " square Biobrane® dressing
  • Burn wounds measuring >2% - <40% TBSA
  • Patient age: >1 - 70 years

Exclusion Criteria:

  • Ventilator dependence
  • Pregnancy/Lactation
  • Mechanism of injury was electrical, chemical or frostbite
  • Co-morbidity which may compromise healing
  • Known allergy to porcine or porcine products

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of healing
Time Frame: Day 14
Day 14

Secondary Outcome Measures

Outcome Measure
Time Frame
Scarring
Time Frame: 6 months, 1 year, 18 months and 2 years
6 months, 1 year, 18 months and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aubrey Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

February 10, 2010

First Submitted That Met QC Criteria

February 11, 2010

First Posted (ESTIMATE)

February 12, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 26, 2015

Last Update Submitted That Met QC Criteria

January 23, 2015

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #AW-101508MC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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