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Recruiting Not applicable NCT07261982

Analysis of the Efficacy of Pressure Pad vs Pressure Bandage Immobilisation for Snake Bite First Aid in Healthy Volunteers.

No applicable phase (e.g. observational)
Conditions: Snake Bites Snakebite Snake Envenomation Snake Bite First Aid

Sponsor: Townsville University Hospital

trial.available_in: БГ
Overview
Snake bite affects thousands of Australians every year, but few die as a result due to high quality first aid and timely medical care. Good first aid should be simple, standardised, use minimal or readily available equipment, and be able to be utilised effectively with no or minimal training by the rescuer. Over time the first aid methods used to manage snake bite in Australia have been questioned due to issues with efficacy, and some emerging evidence of harm from their use. There is little experimental data in the literature to support current first aid practices, and what exists suggests further research is required. This study aims to examine and compare the effectiveness of two first aid methods by tracking the movement of a mock venom through the body when each first aid method is used. This will provide important information about the suitability of current techniques used in Australia and whether a proposed simpler alternative technique is as effective. Currently, initial treatment of snake bite involves early first aid with the application of a pressure bandage and immobilisation (PBI) of the limb. There is limited data to support the basis of this technique and emerging evidence of harm when applied incorrectly. This project sets out to evaluate PBI compared to another technique involving the application of a pressure pad (PP) at the bite site (which is easier to do, and used in many countries outside of Australia). The project aims to determine whether each technique is effective, and whether the PP technique is at least as effective as PBI. To do this 24 participants will be recruited to undergo study with mock venom injected into their hand or foot and having either PBI or PP applied. The mock venom will then be traced with a gamma camera to determine rate of flow through the lymphatic system, which is how venom travels in the body. It is expected that the project will demonstrate the efficacy of both techniques, and that the PP will be at least as effective as PBI. This will provide a basis for change in the current first aid recommendations for snake bite first aid in Australia, and improve the care provided.
Description
Snake bite affects over 5 million people worldwide each year, with between 80000 and 137000 deaths. In Australia there are over 10000 snake bites annually, with over one third of these resulting in envenomation. Of those envenomed, only 2 to 4 die each year since the development of antivenom and the institution of appropriate first aid. The current standard of first aid for snake bite in Australia is the application of the Pressure Bandage Immobilisation (PBI) technique that was originally described by Sutherland et al. in 1979. However, since the development of this technique there has been critique and debate in the medical literature surrounding the actual efficacy of the method when applied in the field. Much of this critique centred around inappropriate application of the technique, insufficient pressure in the application of the bandage, or lack of immobilisation. Despite the popularity of PBI technique, there are still large numbers of patients presenting with snake bite without having any first aid applied at all. Retrospective analysis by some of the original publication by Sutherland has also called into question the validity of the technique itself. Yet, with the inception of PBI and antivenom, the number of snake bite deaths in this country has decreased significantly. As such the technique has been promulgated without much question and remains the recommended method of snake bite first aid in Australia by the Australian Resuscitation Council (ARC). Recently however, there have been calls for more robust research into snake bite first aid, especially with growing evidence of harm (including ineffective compression, pressure injury, nerve injury, limb amputation etc) that is likely the direct result of incorrect application of the PBI technique. The key principles of first aid are to preserve life, prevent deterioration and promote recovery. One of the key objectives of the ARC is to promote simplicity and uniformity in techniques used in resuscitation. Australian venomous snakes of medical significance all come from the family Elapidae, which are not known for a strong localised tissue effect from their venom. This in is contrast to other countries who also have venomous snakes from the Viperidae family whose venoms often contain strongly myotoxic and locally necrotic venom components. As such, the PBI technique has largely been avoided in locations outside Australia due to concerns for compartmentalisation of necrotoxic and myotoxic venom worsening localised effects. Promising data has emerged from research in Myanmar that supports the use of a more localised Pressure Pad (PP) or "Monash method" technique (which is popular in many areas outside Australia) that is simpler to apply correctly, less likely to cause injury to the patient, and as such may be superior to the current PBI method for Australian snake bite first aid. Most notably for the PP technique, data from its use in envenomated patients does not indicate an increase in
Who can participate
Inclusion Criteria: * Age 18 years old or greater * No known or clinically evident lymphatic condition (eg. lymphoedema, lymph node surgery etc) * No known cardiac failure * No known peripheral vascular disease * No known renal or hepatic impairment * No known lymphoma Exclusion Criteria: * Age less than 18 years old * Pregnant * Breast feeding * Allergy to Technetium-99m sulphur colloid * Presence of any of the conditions mentioned in the inclusion criteria
Locations 1
Australia (1)
Queensland X-Ray
Hyde Park , Queensland
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
18.07.2025
Completion date
01.02.2027
Registry ID
NCT07261982
Source
anzctr
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