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

NCT ID: NCT03035695

Last Updated: 2017-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2012-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Axiostat®

Intervention Type: DEVICE

Cotton Gauze

Cotton Gauze Size: 8 x 5 cm

Group Type: ACTIVE_COMPARATOR

Cotton Gauze

Intervention Type: DEVICE

Interventions

Axiostat®

Intervention Type: DEVICE

Cotton Gauze

Intervention Type: DEVICE

Other Intervention Names

Haemostatic dressing

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Axio Biosolutions Pvt. Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. Mohmmad Kabeer

Role: PRINCIPAL_INVESTIGATOR

Malabar Institute of Medical Sciences

Locations

Malabar Insitute of Medical Sciences

Calicut, Kerala, India

Countries

India

Other Identifiers

ABPL/003

Identifier Type: -

Identifier Source: org_study_id