Bleeding Clinical Trial
Official title:
Pre Hospital Hemorrhagic Control Effectiveness of Axiostat® Dressing Versus Conventional Method in Acute Hemorrhage Due to Trauma
The aim of this study was to evaluate the efficacy and safety to use external haemostatic between Axiostat® (Chitosan haemostatic dressing) and conventional cotton gauze dressing as a pre hospital acute hemorrhagic control in trauma in ambulance settings.
Abstract:
Accidents and trauma comprise leading causes of death and disability throughout the world.
In developing countries such as India, where emergency trauma care is still in its infancy,
it accounts for almost 10% deaths every year. Lack of adequate pre-hospital care and
uncontrolled bleeding from wound site are stated to be the prominent reasons for such
deaths.
In this study, a novel chitosan-based haemostatic dressing (Axiostat®, Axio Biosolutions,
India) was investigated as an initial hemorrhage controlling device in pre-hospital
scenario. The study was conducted with the help of 35 Emergency Medical Technicians (EMTs).
A total of 133 patients with scalp wound injury were identified for the study, of which 104
patients meeting the selection criteria were included in the study. The selected patients
were randomly assigned into two groups, the test group consisting of 47 subjects received
Axiostat® treatment; whereas, 57 subjects in the control group were treated with a
conventional cotton-gauze dressing. All subjects needed suturing as the subjects included in
the study were brought with open scalp wounds.
The Axiostat® showed a superior efficacy in controlling bleeding in comparison to the cotton
gauze. The average time for haemostasis with cotton gauze dressing was about 18.56 ± 5.04
minutes; while with Axiostat® haemostasis was achieved in less than 5 minutes (4.68 ± 1.04
min).
On analyzing this study, it was evident that Axiostat® dressing enables early haemostasis
which prevents much blood loss and the wound becomes very clean on removal of dressing for
later wound suturing when compared to normal cotton gauze.
These findings demonstrated the potential of Axiostat® as a first-line intervention in
controlling acute hemorrhage in the pre-hospital scenarios.
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