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Clinical Trials/NCT01067729
NCT01067729
Terminated
Not Applicable

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

Aubrey Inc.3 sites in 1 countryNovember 2009
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ConditionsBurns

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Burns
Sponsor
Aubrey Inc.
Locations
3
Primary Endpoint
Rate of healing
Status
Terminated
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
November 2009
End Date
June 2011
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Aubrey Inc.

Eligibility 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

Outcomes

Primary Outcomes

Rate of healing

Time Frame: Day 14

Secondary Outcomes

  • Scarring(6 months, 1 year, 18 months and 2 years)

Study Sites (3)

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