Multi-Center, Prospective, Randomized, Comparison of AWBAT™-D vs. Xeroform™ or Glucan II™ for Treatment of Donor Sites in Burn Surgery

NCT ID: NCT00964470

Last Updated: 2010-06-22

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Brief Summary

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The purpose of this study is to compare the rate of healing and the non-adherence of three types of dressings. The study will also compare rate of infection, scarring and perception of pain associated with treatment.

Detailed Description

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The purpose of this study is to evaluate AWBAT™-D compared to Xeroform™ or Glucan II™ for the treatment of donor sites in burn surgery.

Primary Study Goals:

* To compare the rate of healing of donor sites.
* To compare patient reported perception of pain
* To compare the potential clinical complication rates of:

* non-adherence,
* seroma
* hematoma
* infection

Secondary Study Goal:

• To compare clinical outcome of donor sites: scarring based on the Vancouver Scar Scale.

Conditions

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Treatment of Donor Site 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™-D and XEROFORM™ OR GLUCAN II™ dressings

Dressing, donor site dressings

Intervention Type DEVICE

Other Intervention Names

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AWBAT™-D and XEROFORM™ OR GLUCAN II™ donor site dressings

Eligibility Criteria

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Inclusion Criteria

* Burn wounds measuring 1% - 30% TBSA requiring skin grafting
* Anterior bilateral donor sites of approximately the same size taken from the thighs or abdomen

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

18 Years

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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Wishard Health Services Burn Center

Indianapolis, Indiana, United States

Site Status RECRUITING

The University Hospital Burn Center Cincinnati

Cincinnati, Ohio, United States

Site Status RECRUITING

Firefighter's Regional Burn Center

Memphis, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Steven Moss

Role: CONTACT

760-602-8300

Tara Cordova

Role: CONTACT

760-602-8300

Facility Contacts

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Rajiv Sood, MD

Role: primary

317-278-1022

J. Kevin Bailey, MD

Role: primary

513-558-4361

Rich Branson, MD

Role: backup

513-558-6785

William Hickerson, MD

Role: primary

901-448-2579

Lisa K Mason-Sutton, BSN

Role: backup

901-448-2525

Other Identifiers

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#AW-101008MC-DS

Identifier Type: -

Identifier Source: org_study_id

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