Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000765224
Ethics application status
Approved
Date submitted
1/09/2009
Date registered
3/09/2009
Date last updated
3/12/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised, Prospective Study of the Treatment of Superficial Partial-Thickness Burns:AWBAT (Trademark) vs. Biobrane (Registered Trademark)
Scientific title
A Randomised, Prospective Study of the Treatment of Superficial Partial-Thickness Burns:AWBAT (Tradmark) vs. Biobrane (Registered Trademark)
Secondary ID [1] 283680 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Superficial partial-thickness burns 243613 0
Condition category
Condition code
Surgery 239908 239908 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 241200 0
Treatment: Devices
Comparator / control treatment
Biobrane (like AWBAT) contains fragments of porcine type 1 collagen which convert burn exudate fibrinogen into fibrin. Both materials work identically except the peptide fragments in AWBAT are less sterically obstructed, therefore the conversion (and thus adhesion) are quicker.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.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 240693 0
Length of stay
Timepoint [1] 240693 0
Daily from randomisation to discharge
Primary outcome [2] 240702 0
Rate of epithelialisation (although the length of stay is often not directly related to healing and more dependent on the ease of treating these patients as out-patients post-application). In burns of the depth studies, epithelialisation will be completed by day 14 at the latest.
Timepoint [2] 240702 0
Daily from randomisation until discharge.
Secondary outcome [1] 257332 0
Perceived pain measured according to Mayo Clinic Visual analogue scale.
Timepoint [1] 257332 0
Daily from randomisation until discharge. Additional measures may be made during therapy and procedures (dressing changes)

Eligibility
Key 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%
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation tables linked to sealed envelopes will be used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All patients meeting inclusion criteria and displaying no exclusion criteria will be approached to participate. Treatment allocation is per randomisation tables in study appendix (pertains to site to receive AWBAT vs site to receive Biobrane
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Patients receive both AWBAT and Biobrane to burns at separate sites or the same site (large area) thus acting as their own active control
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/10/2009
Actual
22/10/2009
Date of last participant enrolment
Anticipated
Actual
16/09/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237558 0
Hospital
Name [1] 237558 0
Royal Adelaide Hospital
Country [1] 237558 0
Australia
Funding source category [2] 237559 0
Self funded/Unfunded
Name [2] 237559 0
Country [2] 237559 0
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
North Terrace,
Adelaide 5000,
South Australia
Country
Australia
Secondary sponsor category [1] 237034 0
Commercial sector/Industry
Name [1] 237034 0
Aubrey, Inc.
Address [1] 237034 0
5930, Sea Lion Place,
Suite 100,
Carlsbad,
California 92010
Country [1] 237034 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243691 0
Royal Adelaide Hospital Research Ethjics Committee
Ethics committee address [1] 243691 0
Ethics committee country [1] 243691 0
Australia
Date submitted for ethics approval [1] 243691 0
Approval date [1] 243691 0
31/08/2009
Ethics approval number [1] 243691 0
090810

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30102 0
A/Prof John E Greenwood
Address 30102 0
Adult Burn Centre, Royal Adelaide Hospital, North Terrace, Adelaide 5000, South Australia
Country 30102 0
Australia
Phone 30102 0
+61 8 8222 2233
Fax 30102 0
+61 8 8222 5676
Email 30102 0
[email protected]
Contact person for public queries
Name 13349 0
John E Greenwood
Address 13349 0
Burns Unit
Royal Adelaide Hospital
North Terrace,
Adelaide 5000
South Australia
Country 13349 0
Australia
Phone 13349 0
+61 422 000809
Fax 13349 0
+61 8 8222 5676
Email 13349 0
[email protected]
Contact person for scientific queries
Name 4277 0
John E Greenwood
Address 4277 0
Burns Unit
Royal Adelaide Hospital
North Terrace,
Adelaide 5000
South Australia
Country 4277 0
Australia
Phone 4277 0
+61 422 000809
Fax 4277 0
+61 8 8222 5676
Email 4277 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.