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Trial registered on ANZCTR

Registration number

ACTRN12606000420549

Ethics application status

Not yet submitted

Date submitted

22/09/2006

Date registered

29/09/2006

Date last updated

29/09/2006

Type of registration

Prospectively registered

Titles & IDs

Public title

An investigation of current pressure bandage methods for snake bite.

Scientific title

A randomised controlled trial of materials for current pressure bandaging and the possible monash pressure pad methods of first aid for snake bite to assess the pressure levels of the different materials and methods.

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Healthy volunteers.

Condition category

Condition code

Other

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This research project involves two smaller substudies involving interventions. The first intervention group will be used to compare the efficacy of different materials for pressure immobilization (PI) first aid. Participants in this group will be bandaged with the alternative material 6 times and bandages will be left in place for 15mins. Only one limb will be bandaged at any one time and there will be a break of atleast half on hour between bandagings on the same limb. We anticipate the intervention group will be treated with a 15cm x 1.6m heavy elastic bandage but have not chosen a particular brand yet. The actr will be notified.

The second substudy will compare two methods of first aid, the current PI measures and the possible Monash pressure pad method. Participants in this group will be bandaged with the alternative method 6 times and bandages will be left in place for 15mins. Only one limb will be bandaged at any one time and there will be a break of atleast half on hour between bandagings on the same limb.The intervention group undergoing the monash method treatment will be treated with standard triangular bandages of dimension 110x110x155 cm, the Smith and Nephew brand is most likely but we will confirm this.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

The control group in both respective substudies will be bandaged according to current recommendations and will be bandaged 6 times and bandages will be left in place for 15mins. Only one limb will be bandaged at any one time and there will be a break of atleast half on hour between bandagings on the same limb. For the control group handy crepe bandaging will be used. Bandages of dimensions 15cm x 1.6m.

Control group

Active

Outcomes

Primary outcome [1]

Outcome is a significant difference in pressure between two types of bandaging material or between two methods of bandaging. The magnitude of this difference will be defined from study 1 but will be stated and reported to the ACTR prior to commencing the randomized study.

Timepoint [1]

Measured at time 0, 5mins and 15 mins and in the few people with bandages in place for an hour at 15 minute intervals for that hour.

Secondary outcome [1]

Comfort of the bandaged volunteer

Timepoint [1]

Monitored at all times and surveyed at 0, 15, 30, 45 and 60 minutes or until the last of these times when bandages are still in place.

Eligibility

Key inclusion criteria

Inclusion criteria for bandagers include -doctors, nurses, paramedic, snake handler or members of the general public.

Minimum age

18 Years

Maximum age

Not stated

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

People will be excluded from being bandaged if they have known skin or circulatory conditions that may cause them added discomfort.

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)

Central randomization by computer

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer generated randomization using Microsoft Excel

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

Phase

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

20/10/2006

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Menzies

Address [1]

Country [1]

Australia

Primary sponsor type

Other

Name

Menzies

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Summary

Brief summary

We think that the bandaging people put in place when someone is bitten by a snake is not stopping that person getting sick. 

We want to test if this is because of the bandages we use not being very good, or if the first aid is just difficult to put in place correctly. We will test different materials and a different way of bandaging. We know that the bandages need to be tight, but not too tight and we can measure the pressure inside the bandage to see if they are likely to help someone who has been bitten. We can use the measurments we get to judge which method and/or material is easiest to use.

Experimentally first aid has been recommended with certain pressures corresponding to the different techniques. For the pressure immobilization method this corresponds to 40-70 mmHg in the upper limb and 55-70mmHg in the lower limb. In the Monash method, pressures greater than 70mmHg were found to be neccessary on all limbs.

We believe that if these pressures cannot be achieved then neither can effective bandaging. 

1/   We will first do a pilot study on mannequin's and ourselves to work out the standard deviation and spread of the variance between typical bandage applications. This initial study will also allow us to decide what material  we would like to compare to crepe (eg. thicker crepe, elastic compression bandage, pantihose). 

2/   We will then conduct a study to find out the spread of pressures generated by five separate subpopulations.
a. Emergency nursing staff (4 to 6 people) putting a bandage on 6 times each on a leg and arm.
b. Ambulance officers (4 to 6 people) putting a bandage on 6 times each on a leg and arm.
c. Doctors (4 to 6 people) putting a bandage on 6 times each on a leg and arm.
d. Snake handlers (4 to 6 people) putting a bandage on 6 times each on a leg and arm.  
e. General public (4 to 6 people) putting a bandage on 6 times each on a leg and arm. This group to have never put on a bandage before. 

3/     Then once we have calculated the variance within an individual, within groups and between groups and can calculate a sample size we will compare materials in a randomised study. We will test our preferred material against crepe with the help of volunteers who will bandage alternate lower limbs on the same subject with each material, eg. left crepe and right gold standard.

4/   The other trial will compare pressure immobilization to the new Monash method. We will ask health professionals to perform the first aid in the same way as we compared materials. We will measure all pressures to ascertain which is more often correctly applied.

5/ In a small subset of volunteers we will ask them to keep the bandages on for longer while stationary or travelling and will compare the changes in pressure between these two groups.

We aim to find out if a better material could be used, or if there is a technique that is easier to put in place, or if extra training improves the application of the current first aid technique.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Elizabeth Canale

Address

PO Box 41096
Casuarina NT 0811

Country

Australia

Phone

+61 8 89227844

Fax

+61 8 89275187

Elizabeth.Canale@menzies.edu.au

Contact person for scientific queries

Name

Professor Bart Currie

Address

PO Box 41096
Casuarina NT 0811

Country

Australia

Phone

+61 8 89228196

Fax

+61 8 89275187

bart@menzies.edu.au

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.

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