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

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.

Study Overview

• Status: Completed
• Conditions: Bleeding
• Intervention / Treatment: Device: Axiostat®; Device: Cotton Gauze

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.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Kerela
    • Calicut, Kerela, India, 673016
      • Malabar Insitute of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age greater than or equal to 18 years.
• Patient and/or patient's legal representative and/or impartial witness have been informed of the nature of the study and agree to its provisions and have provided written informed consent as approved by the IEC of MIMS, Kerala, India.
• Patients with bleeding wounds over scalp which can due to any injury.
• The wounds must be bleeding at the time of baseline assessment.
• The targeted wound size should be such that it should be covered by single available size of the study device as per the instructions for use.

Exclusion Criteria:

• The exclusion criteria for the study involved prior diagnosis of disease or medical condition affecting the ability of blood to clot (e.g., hemophilia).
• A non-survivable injury as per the investigators' discretion.
• Patients who in the opinion of the investigator may not complete the study for any reason, e.g. Patients requiring immediate suturing. Grossly infected wounds that may reasonably be expected to require multiple debridement procedures prior to clearance of bacteria and non-viable tissue from the wound, in case of old wound.
• Patient is currently participating in an investigational drug or device study that has not yet completed its primary endpoint or interferes with procedure and assessments in this trial.
• Patients with Surgical/iatrogenic wound.
• Patients with a major head injury, spinal injury, neck injury, abdominal injury, deep wound injury, fracture, hemorrhagic shock, foreign materials inside the wound like stab injury.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Axiostat® Size; Device: Axiostat® Size: 8 x 5 cm Axiostat® is a sterile, non-absorbable haemostatic dressing intended to control profuse bleeding within minutes of application by providing an active mechanical barrier to the wound site. Mechanism of action is such that Axiostat® is an extremely positive dressing that becomes very sticky in the presence of negatively charged blood and thus seals the wound area.	Device: Axiostat®; Other Names: Haemostatic dressing
Active Comparator: Cotton Gauze; Cotton Gauze Size: 8 x 5 cm	Device: Cotton Gauze

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to achieve hemostasis	Time to achieve hemostasis by observing the time at which blood oozing through or from periphery of the dressing stops.	1 Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with rebleeding	Number of patients with rebleeding will be counted (unit of measurement is number/count of patients)	1 Day

Collaborators and Investigators

• Sponsor: Axio Biosolutions Pvt. Ltd.
• Investigators: Principal Investigator: Dr. Mohmmad Kabeer, Malabar Institute of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: January 23, 2017
• First Submitted That Met QC Criteria: January 26, 2017
• First Posted (Estimate): January 30, 2017

Study Record Updates

• Last Update Posted (Estimate): January 30, 2017
• Last Update Submitted That Met QC Criteria: January 26, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Trauma; Scalp injuries; Profused Bleeding; Accident
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Coagulants; Hemostatics
• Other Study ID Numbers: ABPL/003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No