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DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
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Trial registered on ANZCTR
Registration number
ACTRN12623000896673
Ethics application status
Approved
Date submitted
3/08/2023
Date registered
21/08/2023
Date last updated
21/08/2023
Date data sharing statement initially provided
21/08/2023
Date results information initially provided
21/08/2023
Type of registration
Retrospectively registered
Titles & IDs
Public title
Pressure Bandage for Australian Snake Bite
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Scientific title
Pressure exerted by application of pressure bandage by first aiders in PBI technique
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Secondary ID [1]
310014
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None
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Universal Trial Number (UTN)
U1111-1294-4927
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Australian snake envenomation
330544
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Condition category
Condition code
Emergency medicine
327386
327386
0
0
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Other emergency care
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Application of pressure bandage to upper limb for <2 min. 10 cm firm elastic bandage to be applied over the sphygmomanometer cuff by experienced first aider, first aid trainer or Health Care Professional (HCP). Pressure to be the same as would be used for snake bite pressure bandage. Bandage to be removed once pressure recorded or if pain troubling at any time. This step was supervised by the recipient of the bandage, who was an experienced first aider, first aid trainer or HCP.
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Intervention code [1]
326443
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Treatment: Devices
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Comparator / control treatment
None
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
335266
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Pressure measured by sphygmomanometer cuff under bandage under pressure bandage
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Assessment method [1]
335266
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Timepoint [1]
335266
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<2 min after application of the pressure bandage
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Secondary outcome [1]
423657
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Pain experienced by "patient." Pain out of 10 verbal report
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Assessment method [1]
423657
0
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Timepoint [1]
423657
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<2 min after application of bandage
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Eligibility
Key inclusion criteria
Adult, delegate in first aid breakout session of 2023 Spark of Life Conference. Consent to participate
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
None
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people administering the treatment/s
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Descriptive statistics in Excel
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
3/06/2023
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Date of last participant enrolment
Anticipated
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Actual
3/06/2023
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Date of last data collection
Anticipated
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Actual
3/06/2023
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Sample size
Target
100
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Accrual to date
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Final
86
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
314191
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Commercial sector/Industry
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Name [1]
314191
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St John Ambulance Australia
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Address [1]
314191
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PO Box 292
Deakin West ACT 2600
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Country [1]
314191
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
St John Ambulance Australia
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Address
PO Box 292
Deakin West ACT 2600
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Country
Australia
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Secondary sponsor category [1]
316120
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None
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Name [1]
316120
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Address [1]
316120
0
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Country [1]
316120
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
313318
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St John Ambulance Australia Human Research Ethics Committee
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Ethics committee address [1]
313318
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PO Box 292
Deakin West ACT 2600
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Ethics committee country [1]
313318
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Australia
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Date submitted for ethics approval [1]
313318
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07/03/2023
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Approval date [1]
313318
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26/04/2023
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Ethics approval number [1]
313318
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SJAA23/01
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Summary
Brief summary
The application of pressure bandage, combined with immobilisation of the bitten limb, has been the standard of care for Australian snake bite since the studies by Straun Sutherland. The technique was shown to slow the systemic absorption of an analogue of the venom of the elapid family of snakes native to Australia by cessation of lymphatic flow carrying the venom from the affected limb. A recent systematic review by Bert Avau and others has recommended against the use of the pressure bandage for 2 main reasons: First that the venom of the crotalid family of snakes (found in many countries) has a different mechanism of action resulting in increased necrosis at the bite site and second because studies have demonstrated that lay application of pressure bandages exerts too little pressure to stop lymphatic flow. Avau et al cite multiple papers disputing the efficacy of the technique or the ability of first aiders to apply sufficient pressure.. The current study aimed to determine if experienced first aiders are able to apply sufficient pressure to stop lymphatic flow (estimated to be 40 - 70 mmHg for the upper limb and 55 – 70 mmHg for the lower limb)
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Trial website
None
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
127718
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Dr Finlay Macneil
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Address
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Finlay Macneil, St John Ambulance Australia, 47/26, Watt Street, Gosford, NSW 2250
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Country
127718
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Australia
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Phone
127718
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+61 243244633
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Fax
127718
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+61243116919
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Email
127718
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[email protected]
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Contact person for public queries
Name
127719
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Dr Finlay Macneil
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Address
127719
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Finlay Macneil, St John Ambulance Australia, 47/26, Watt Street, Gosford, NSW 2250
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Country
127719
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Australia
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Phone
127719
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+61 243244633
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Fax
127719
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+61243116919
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Email
127719
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[email protected]
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Contact person for scientific queries
Name
127720
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Dr Finlay Macneil
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Address
127720
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Finlay Macneil, St John Ambulance Australia, 47/26, Watt Street, Gosford, NSW 2250
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Country
127720
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Australia
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Phone
127720
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+61 243244633
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Fax
127720
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+61243116919
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Email
127720
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Profession, pressure generated, pain score of recipient. (no demographic details have been saved)
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When will data be available (start and end dates)?
1 December 23 - 1 December 27
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Available to whom?
Anybody on request to PI
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Available for what types of analyses?
Statistical
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How or where can data be obtained?
By email on
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
19722
Informed consent form
386165-(Uploaded-18-07-2023-12-31-47)-Study-related document.doc
19723
Ethical approval
[email protected]
386165-(Uploaded-03-08-2023-15-21-03)-Study-related document.pdf
20068
Study protocol
386165-(Uploaded-21-08-2023-13-05-12)-Study-related document.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.
Download to PDF