NCT03035695

Studying Safety & Efficacy of Axiostat® Dressing in Acute Hemorrhage Due to Trauma-Comparative Study

Pre Hospital Hemorrhagic Control Effectiveness of Axiostat® Dressing Versus Conventional Method in Acute Hemorrhage Due to Trauma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Axio Biosolutions Pvt. Ltd. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Bleeding

Interventions

Type	Name	Description
DEVICE	Axiostat®
DEVICE	Cotton Gauze

Timeline

• Start date: 2012-05-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2017-01-30
• Last updated: 2017-01-30

Locations

1 site across 1 country: India