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

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ClinicalTrials.gov Identifier: NCT03035695
Recruitment Status : Completed
First Posted : January 30, 2017
Last Update Posted : January 30, 2017
Sponsor:
Information provided by (Responsible Party):
Axio Biosolutions Pvt. Ltd.

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.

Condition or disease Intervention/treatment Phase
Bleeding Device: Axiostat® Device: Cotton Gauze Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pre Hospital Hemorrhagic Control Effectiveness of Axiostat® Dressing Versus Conventional Method in Acute Hemorrhage Due to Trauma
Actual Study Start Date : May 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


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 Name: Haemostatic dressing

Active Comparator: Cotton Gauze
Cotton Gauze Size: 8 x 5 cm
Device: Cotton Gauze



Primary Outcome Measures :
  1. Time to achieve hemostasis [ Time Frame: 1 Day ]
    Time to achieve hemostasis by observing the time at which blood oozing through or from periphery of the dressing stops.


Secondary Outcome Measures :
  1. Number of patients with rebleeding [ Time Frame: 1 Day ]
    Number of patients with rebleeding will be counted (unit of measurement is number/count of patients)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035695


Locations
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India
Malabar Insitute of Medical Sciences
Calicut, Kerela, India, 673016
Sponsors and Collaborators
Axio Biosolutions Pvt. Ltd.
Investigators
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Principal Investigator: Dr. Mohmmad Kabeer Malabar Institute of Medical Sciences

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Responsible Party: Axio Biosolutions Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT03035695     History of Changes
Other Study ID Numbers: ABPL/003
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Axio Biosolutions Pvt. Ltd.:
Trauma
Scalp injuries
Profused Bleeding
Accident
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Hemostatics
Coagulants