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

NCT ID: NCT01067729

Last Updated: 2015-01-26

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

TERMINATED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Burns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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AWBAT Wound Dressing

Intervention Type DEVICE

AWBAT™, Biobrane®

Comparison of burn dressings on randomized body sites using patient as own control

Intervention Type DEVICE

Other Intervention Names

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Biobrane

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aubrey Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Aubrey Inc.

Locations

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UC Irvine Burn Center

Irvine, California, United States

Site Status

University of Missouri Health Care

Columbia, Missouri, United States

Site Status

Shriners Hospitals for Children

Galveston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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#AW-101508MC

Identifier Type: -

Identifier Source: org_study_id

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