Burns
Conditions
Keywords
Burn, Superficial burns, Partial thickness burns, Rate of healing, Infection rate, Pain perception, Non adherence, Scarring
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.
Interventions
DEVICEAWBAT Wound Dressing
DEVICEAWBAT™, Biobrane®
Comparison of burn dressings on randomized body sites using patient as own control
Sponsors
Aubrey Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of healing | Day 14 |
Secondary
| Measure | Time frame |
|---|---|
| Scarring | 6 months, 1 year, 18 months and 2 years |
Countries
United States
Outcome results
None listed