Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000400460
Ethics application status
Approved
Date submitted
9/04/2025
Date registered
2/05/2025
Date last updated
2/05/2025
Date data sharing statement initially provided
2/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Does Blastx accelerate wound closure in chronic burn injuries?
Scientific title
Prospective randomised phase 4 clinical trial of the effect of Blastx on wound closure rates in chronic burn injuries
Secondary ID [1] 314169 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burns greater than 4 weeks old 337019 0
Condition category
Condition code
Injuries and Accidents 333470 333470 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with burn in juries >4 weeks old will be allocated into 2 arms of the study. The trial arm will be having 3mm thick blastx wound gel applied directly to the burn wound by burns nurses in clinic. This will htne be covered with a non-adherent pad. Patients will have Blastx applied to the burn twice a week with wound measurement occurring via photography with AI intelligence.. This will continue until wound closure.
Intervention code [1] 330770 0
Treatment: Drugs
Comparator / control treatment
Patients with burn injuries >4 weeks old will be allocated into 2 arms of the study. The comparator arm will be having aquacel ag and a non-adherent pad applied to the burn twice a week with wound measurement occurring via photography with AI intelligence.
Control group
Active

Outcomes
Primary outcome [1] 341048 0
Number of dressing changes required until closure
Timepoint [1] 341048 0
Baseline, then at every appointment (twice a week) until wound closure. There is no maximum duration of treatment
Primary outcome [2] 341049 0
total cost of treatment
Timepoint [2] 341049 0
at completion of treatment
Secondary outcome [1] 445951 0
scar outcome
Timepoint [1] 445951 0
at completion of treatment and 3 months post completion of treatment

Eligibility
Key inclusion criteria
patient aged 18 years and over, burns that are >4 weeks old, burns managed by Burns team and burns that involve <1% Total body surface area (TBSA).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients aged 17 years and under, burns under 4 weeks old, burns sustained to specific anatomical locations, patients unable to perform informed consent or are receiving telehealth care.


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)
allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomized using r-statistical software through a biostatition
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/05/2025
Actual
Date of last participant enrolment
Anticipated
31/08/2025
Actual
Date of last data collection
Anticipated
31/08/2025
Actual
Sample size
Target
126
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 318685 0
Hospital
Name [1] 318685 0
Concord Hospital
Country [1] 318685 0
Australia
Primary sponsor type
Hospital
Name
Concord Hospital
Address
Country
Australia
Secondary sponsor category [1] 321111 0
None
Name [1] 321111 0
Address [1] 321111 0
Country [1] 321111 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317295 0
Sydney Local Health District HREC – Concord Repatriation General Hospital
Ethics committee address [1] 317295 0
Ethics committee country [1] 317295 0
Australia
Date submitted for ethics approval [1] 317295 0
13/11/2023
Approval date [1] 317295 0
12/02/2025
Ethics approval number [1] 317295 0

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

Contacts
Principal investigator
Name 140598 0
Ms Emma Allan
Address 140598 0
Burns Unit Concord Hospital. Concord Repatriation General Hospital, Hospital Road, Concord NSW, 2139.
Country 140598 0
Australia
Phone 140598 0
+61 2 9767 7776
Fax 140598 0
Email 140598 0
[email protected]
Contact person for public queries
Name 140599 0
Emma Allan
Address 140599 0
Burns Unit Concord Hospital. Concord Repatriation General Hospital, Hospital Road, Concord NSW, 2139.
Country 140599 0
Australia
Phone 140599 0
+61 0297675000
Fax 140599 0
Email 140599 0
[email protected]
Contact person for scientific queries
Name 140600 0
Emma Allan
Address 140600 0
Burns Unit Concord Hospital. Concord Repatriation General Hospital, Hospital Road, Concord NSW, 2139.
Country 140600 0
Australia
Phone 140600 0
+61 0297675000
Fax 140600 0
Email 140600 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24622Study protocol    Master CLINICAL TRIAL PROTOCOL Version 4 Clean (1).docx



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.