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

A

Aubrey

Status

Terminated

Conditions

Burns

Treatments

Device: AWBAT Wound Dressing
Device: AWBAT™, Biobrane®

Study type

Interventional

Funder types

Industry

Identifiers

NCT01067729
#AW-101508MC

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

1 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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