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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Aubrey Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Aubrey Inc.
ClinicalTrials.gov Identifier:
NCT01067729
First received: February 10, 2010
Last updated: June 21, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention
Burns
Device: AWBAT Wound Dressing
Device: AWBAT™, Biobrane®

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Prospective Study of the Treatment of Superficial Partial-Thickness Burns: AWBAT™ vs. Biobrane®

Resource links provided by NLM:


Further study details as provided by Aubrey Inc.:

Primary Outcome Measures:
  • Rate of healing [ Time Frame: Day 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Scarring [ Time Frame: 6 months, 1 year, 18 months and 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2009
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: AWBAT Wound Dressing
    TBD
    Other Name: Biobrane
    Device: AWBAT™, Biobrane®
    Comparison of burn dressings on randomized body sites using patient as own control
    Other Name: AWBAT™, Biobrane®
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.

  Eligibility

Ages Eligible for Study:   1 Year to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01067729

Locations
United States, California
UC Irvine Burn Center
Irvine, California, United States, 92868
United States, Missouri
University of Missouri Health Care
Columbia, Missouri, United States, 65212
United States, Texas
Shriners Hospitals for Children
Galveston, Texas, United States, 77550
Sponsors and Collaborators
Aubrey Inc.
  More Information

No publications provided

Responsible Party: Stephen Moss/President, Aubrey Inc.
ClinicalTrials.gov Identifier: NCT01067729     History of Changes
Other Study ID Numbers: #AW-101508MC
Study First Received: February 10, 2010
Last Updated: June 21, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Aubrey Inc.:
Burn
Superficial burns
Partial thickness burns
Rate of healing
Infection rate
Pain perception
Non adherence
Scarring

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on July 26, 2014