Trial Review

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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. 1389 0
Condition category
Condition code
Other 1483 1483 0 0

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] 1372 0
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] 2054 0
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] 2054 0
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] 3544 0
Comfort of the bandaged volunteer
Timepoint [1] 3544 0
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?
No
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
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1621 0
Other
Name [1] 1621 0
Menzies
Country [1] 1621 0
Australia
Primary sponsor type
Other
Name
Menzies
Address
Country
Australia
Secondary sponsor category [1] 1422 0
None
Name [1] 1422 0
Nil
Address [1] 1422 0
Country [1] 1422 0

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 27599 0
Address 27599 0
Country 27599 0
Phone 27599 0
Fax 27599 0
Email 27599 0
Contact person for public queries
Name 10561 0
Elizabeth Canale
Address 10561 0
PO Box 41096
Casuarina NT 0811
Country 10561 0
Australia
Phone 10561 0
+61 8 89227844
Fax 10561 0
+61 8 89275187
Email 10561 0
[email protected]
Contact person for scientific queries
Name 1489 0
Professor Bart Currie
Address 1489 0
PO Box 41096
Casuarina NT 0811
Country 1489 0
Australia
Phone 1489 0
+61 8 89228196
Fax 1489 0
+61 8 89275187
Email 1489 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.