Trial Review

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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 information for consumers
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
Scientific title
Pressure exerted by application of pressure bandage by first aiders in PBI technique
Secondary ID [1] 310014 0
None
Universal Trial Number (UTN)
U1111-1294-4927
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Australian snake envenomation 330544 0
Condition category
Condition code
Emergency medicine 327386 327386 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 326443 0
Treatment: Devices
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335266 0
Pressure measured by sphygmomanometer cuff under bandage under pressure bandage
Timepoint [1] 335266 0
<2 min after application of the pressure bandage
Secondary outcome [1] 423657 0
Pain experienced by "patient." Pain out of 10 verbal report
Timepoint [1] 423657 0
<2 min after application of bandage

Eligibility
Key inclusion criteria
Adult, delegate in first aid breakout session of 2023 Spark of Life Conference. Consent to participate
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics in Excel

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/06/2023
Date of last participant enrolment
Anticipated
Actual
3/06/2023
Date of last data collection
Anticipated
Actual
3/06/2023
Sample size
Target
100
Accrual to date
Final
86
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 314191 0
Commercial sector/Industry
Name [1] 314191 0
St John Ambulance Australia
Country [1] 314191 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
St John Ambulance Australia
Address
PO Box 292
Deakin West ACT 2600
Country
Australia
Secondary sponsor category [1] 316120 0
None
Name [1] 316120 0
Address [1] 316120 0
Country [1] 316120 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313318 0
St John Ambulance Australia Human Research Ethics Committee
Ethics committee address [1] 313318 0
PO Box 292
Deakin West ACT 2600
Ethics committee country [1] 313318 0
Australia
Date submitted for ethics approval [1] 313318 0
07/03/2023
Approval date [1] 313318 0
26/04/2023
Ethics approval number [1] 313318 0
SJAA23/01

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)
Trial website
None
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127718 0
Dr Finlay Macneil
Address 127718 0
Finlay Macneil, St John Ambulance Australia, 47/26, Watt Street, Gosford, NSW 2250
Country 127718 0
Australia
Phone 127718 0
+61 243244633
Fax 127718 0
+61243116919
Email 127718 0
findoc@bigpond.com
Contact person for public queries
Name 127719 0
Dr Finlay Macneil
Address 127719 0
Finlay Macneil, St John Ambulance Australia, 47/26, Watt Street, Gosford, NSW 2250
Country 127719 0
Australia
Phone 127719 0
+61 243244633
Fax 127719 0
+61243116919
Email 127719 0
findoc@bigpond.com
Contact person for scientific queries
Name 127720 0
Dr Finlay Macneil
Address 127720 0
Finlay Macneil, St John Ambulance Australia, 47/26, Watt Street, Gosford, NSW 2250
Country 127720 0
Australia
Phone 127720 0
+61 243244633
Fax 127720 0
+61243116919
Email 127720 0
findoc@bigpond.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Profession, pressure generated, pain score of recipient. (no demographic details have been saved)
When will data be available (start and end dates)?
1 December 23 - 1 December 27
Available to whom?
Anybody on request to PI
Available for what types of analyses?
Statistical
How or where can data be obtained?
By email on findoc@bigpond.com


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19722Informed consent form    386165-(Uploaded-18-07-2023-12-31-47)-Study-related document.doc
19723Ethical approval  findoc@bigpond.com 386165-(Uploaded-03-08-2023-15-21-03)-Study-related document.pdf
20068Study 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.