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A Randomised, Prospective Study of the Treatment of Superficial Partial-Thickness Burns:AWBAT (Trademark) vs. Biobrane (Registered Trademark)

A Randomised, Prospective Study of the Treatment of Superficial Partial-Thickness Burns:AWBAT (Tradmark) vs. Biobrane (Registered Trademark)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000765224
Enrollment
60
Registered
2009-09-03
Start date
2009-10-22
Completion date
2010-09-16
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Biobrane is our gold standard for superficial partial thickness burns. AWBAT is very similar but adheres more rapidly to the wound. This is the rate limiting step in healing and allowing theses patients to be treated as outpatients. The study aims to compare the two in rate of epithelialisation and pain perception (the other issue which keeps burn patients in hospital).

Interventions

AWBAT is a second generation temporary epidermal replacement. It is to be compared with Biobrane (a first generation product with the same indications). Both materials are applied to meticulously cleaned superficial partial thickness burns under general anaesthesia in theatre. The piorcine peptide component in the materials stimulates the conversion of fibrinogen in the burn exudate to fibrin, firmly adhering the material to the burn. Both materials then stay in-situ until the burn re-epithelial

AWBAT is a second generation temporary epidermal replacement. It is to be compared with Biobrane (a first generation product with the same indications). Both materials are applied to meticulously cleaned superficial partial thickness burns under general anaesthesia in theatre. The piorcine peptide component in the materials stimulates the conversion of fibrinogen in the burn exudate to fibrin, firmly adhering the material to the burn. Both materials then stay in-situ until the burn re-epithelialises beneath. Both materials then spontaneously separate. The length of material adherence depends on the burn depth - very superficial 4-5 days, mid-dermal up to 14 days. All participants will receive both Biobrane and AWBAT thus acting as their own controls since Biobrane is the material we currently use routinely according to our surgical protocols.

Sponsors

Royal Adelaide Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

Superficial partial thickness burns Two non-contiguous burn sites of the same approximate size/depth for comparison, OR One burn site large enough to accommodate both a 6” square AWBAT (Trademark) dressing AND a 6” square Biobrane (Registered Trademerk) dressing Burn wounds ranging between 2% < Total Body Surface Area <40%

Exclusion criteria

Delayed presentation (>48 hours) Ventilator dependence Signs of burn wound infection Pregnancy/Lactation Electrical, chemical or frostbite injury Non-English speakers (from an informed consent perspective) Patient from a rural centre where there is a burns link-nurse (Port Pirie, Mount Gambier, Adelaide Hills, Gawler) Co-morbidity which may compromise healing Known allergy to porcine products

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026