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

Primary Purpose

Treatment of Donor Site Burns

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AWBAT™-D and XEROFORM™ OR GLUCAN II™ dressings
Sponsored by
Aubrey Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment of Donor Site Burns focused on measuring Burn, donor site, skin graft, dressing, AWBAT™-D, XEROFORM™, GLUCAN II™

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Wishard Health Services Burn CenterRecruiting
  • The University Hospital Burn Center CincinnatiRecruiting
  • Firefighter's Regional Burn CenterRecruiting

Outcomes

Primary Outcome Measures

• To compare the rate of healing of donor sites. • To compare patient reported perception of pain • To compare the potential clinical complication rates of: o non-adherence, o seroma o hematoma o infection

Secondary Outcome Measures

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

Full Information

First Posted
August 23, 2009
Last Updated
June 21, 2010
Sponsor
Aubrey Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00964470
Brief Title
Multi-Center, Prospective, Randomized, Comparison of AWBAT™-D vs. Xeroform™ or Glucan II™ for Treatment of Donor Sites in Burn Surgery
Acronym
AWBAT-D
Official Title
Multi-Center, Prospective, Randomized, Comparison of AWBAT™-D vs. Xeroform™ or Glucan II™ for Treatment of Donor Sites in Burn Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Aubrey Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment of Donor Site Burns
Keywords
Burn, donor site, skin graft, dressing, AWBAT™-D, XEROFORM™, GLUCAN II™

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
AWBAT™-D and XEROFORM™ OR GLUCAN II™ dressings
Other Intervention Name(s)
AWBAT™-D and XEROFORM™ OR GLUCAN II™ donor site dressings
Intervention Description
Dressing, donor site dressings
Primary Outcome Measure Information:
Title
• To compare the rate of healing of donor sites. • To compare patient reported perception of pain • To compare the potential clinical complication rates of: o non-adherence, o seroma o hematoma o infection
Time Frame
2 year follow-up
Secondary Outcome Measure Information:
Title
• To compare clinical outcome of donor sites: scarring based on the Vancouver Scar Scale.
Time Frame
2 year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steven Moss
Phone
760-602-8300
Email
smoss@aubreyinc.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tara Cordova
Phone
760-602-8300
Email
tcordova@aubreyinc.com
Facility Information:
Facility Name
Wishard Health Services Burn Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rajiv Sood, MD
Phone
317-278-1022
Email
rsood@iupui.edu
First Name & Middle Initial & Last Name & Degree
Rajiv Sood, MD
Facility Name
The University Hospital Burn Center Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J. Kevin Bailey, MD
Phone
513-558-4361
Email
baileyj4@ucmail.uc.edu
First Name & Middle Initial & Last Name & Degree
Rich Branson, MD
Phone
513-558-6785
Email
richard.branson@uc.edu
Facility Name
Firefighter's Regional Burn Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Hickerson, MD
Phone
901-448-2579
Email
bhickerson@mac.com
First Name & Middle Initial & Last Name & Degree
Lisa K Mason-Sutton, BSN
Phone
901-448-2525
Email
lmasonsu@utmem.edu

12. IPD Sharing Statement

Learn more about this trial

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

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