<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03035695</url>
  </required_header>
  <id_info>
    <org_study_id>ABPL/003</org_study_id>
    <nct_id>NCT03035695</nct_id>
  </id_info>
  <brief_title>Studying Safety &amp; Efficacy of Axiostat® Dressing in Acute Hemorrhage Due to Trauma-Comparative Study</brief_title>
  <official_title>Pre Hospital Hemorrhagic Control Effectiveness of Axiostat® Dressing Versus Conventional Method in Acute Hemorrhage Due to Trauma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Axio Biosolutions Pvt. Ltd.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Axio Biosolutions Pvt. Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to evaluate the efficacy and safety to use external haemostatic&#xD;
      between Axiostat® (Chitosan haemostatic dressing) and conventional cotton gauze dressing as a&#xD;
      pre hospital acute hemorrhagic control in trauma in ambulance settings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Abstract:&#xD;
&#xD;
      Accidents and trauma comprise leading causes of death and disability throughout the world. In&#xD;
      developing countries such as India, where emergency trauma care is still in its infancy, it&#xD;
      accounts for almost 10% deaths every year. Lack of adequate pre-hospital care and&#xD;
      uncontrolled bleeding from wound site are stated to be the prominent reasons for such deaths.&#xD;
&#xD;
      In this study, a novel chitosan-based haemostatic dressing (Axiostat®, Axio Biosolutions,&#xD;
      India) was investigated as an initial hemorrhage controlling device in pre-hospital scenario.&#xD;
      The study was conducted with the help of 35 Emergency Medical Technicians (EMTs).&#xD;
&#xD;
      A total of 133 patients with scalp wound injury were identified for the study, of which 104&#xD;
      patients meeting the selection criteria were included in the study. The selected patients&#xD;
      were randomly assigned into two groups, the test group consisting of 47 subjects received&#xD;
      Axiostat® treatment; whereas, 57 subjects in the control group were treated with a&#xD;
      conventional cotton-gauze dressing. All subjects needed suturing as the subjects included in&#xD;
      the study were brought with open scalp wounds.&#xD;
&#xD;
      The Axiostat® showed a superior efficacy in controlling bleeding in comparison to the cotton&#xD;
      gauze. The average time for haemostasis with cotton gauze dressing was about 18.56 ± 5.04&#xD;
      minutes; while with Axiostat® haemostasis was achieved in less than 5 minutes (4.68 ± 1.04&#xD;
      min).&#xD;
&#xD;
      On analyzing this study, it was evident that Axiostat® dressing enables early haemostasis&#xD;
      which prevents much blood loss and the wound becomes very clean on removal of dressing for&#xD;
      later wound suturing when compared to normal cotton gauze.&#xD;
&#xD;
      These findings demonstrated the potential of Axiostat® as a first-line intervention in&#xD;
      controlling acute hemorrhage in the pre-hospital scenarios.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to achieve hemostasis</measure>
    <time_frame>1 Day</time_frame>
    <description>Time to achieve hemostasis by observing the time at which blood oozing through or from periphery of the dressing stops.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with rebleeding</measure>
    <time_frame>1 Day</time_frame>
    <description>Number of patients with rebleeding will be counted (unit of measurement is number/count of patients)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">104</enrollment>
  <condition>Bleeding</condition>
  <arm_group>
    <arm_group_label>Axiostat® Size</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cotton Gauze</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cotton Gauze Size: 8 x 5 cm</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Axiostat®</intervention_name>
    <arm_group_label>Axiostat® Size</arm_group_label>
    <other_name>Haemostatic dressing</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cotton Gauze</intervention_name>
    <arm_group_label>Cotton Gauze</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age greater than or equal to 18 years.&#xD;
&#xD;
          -  Patient and/or patient's legal representative and/or impartial witness have been&#xD;
             informed of the nature of the study and agree to its provisions and have provided&#xD;
             written informed consent as approved by the IEC of MIMS, Kerala, India.&#xD;
&#xD;
          -  Patients with bleeding wounds over scalp which can due to any injury.&#xD;
&#xD;
          -  The wounds must be bleeding at the time of baseline assessment.&#xD;
&#xD;
          -  The targeted wound size should be such that it should be covered by single available&#xD;
             size of the study device as per the instructions for use.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The exclusion criteria for the study involved prior diagnosis of disease or medical&#xD;
             condition affecting the ability of blood to clot (e.g., hemophilia).&#xD;
&#xD;
          -  A non-survivable injury as per the investigators' discretion.&#xD;
&#xD;
          -  Patients who in the opinion of the investigator may not complete the study for any&#xD;
             reason, e.g. Patients requiring immediate suturing. Grossly infected wounds that may&#xD;
             reasonably be expected to require multiple debridement procedures prior to clearance&#xD;
             of bacteria and non-viable tissue from the wound, in case of old wound.&#xD;
&#xD;
          -  Patient is currently participating in an investigational drug or device study that has&#xD;
             not yet completed its primary endpoint or interferes with procedure and assessments in&#xD;
             this trial.&#xD;
&#xD;
          -  Patients with Surgical/iatrogenic wound.&#xD;
&#xD;
          -  Patients with a major head injury, spinal injury, neck injury, abdominal injury, deep&#xD;
             wound injury, fracture, hemorrhagic shock, foreign materials inside the wound like&#xD;
             stab injury.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr. Mohmmad Kabeer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Malabar Institute of Medical Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Malabar Insitute of Medical Sciences</name>
      <address>
        <city>Calicut</city>
        <state>Kerela</state>
        <zip>673016</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>January 26, 2017</last_update_submitted>
  <last_update_submitted_qc>January 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Trauma</keyword>
  <keyword>Scalp injuries</keyword>
  <keyword>Profused Bleeding</keyword>
  <keyword>Accident</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemostatics</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03035695
org study id: ABPL/003
nct id: NCT03035695
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time to achieve hemostasis
time frame: 1 Day
description: Time to achieve hemostasis by observing the time at which blood oozing through or from periphery of the dressing stops.
measure: Number of patients with rebleeding
time frame: 1 Day
description: Number of patients with rebleeding will be counted (unit of measurement is number/count of patients)
arm group label: Axiostat® Size
arm group type: Experimental
description: 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.
arm group label: Cotton Gauze
arm group type: Active Comparator
description: Cotton Gauze Size: 8 x 5 cm
intervention type: Device
intervention name: Axiostat®
arm group label: Axiostat® Size
other name: Haemostatic dressing
intervention type: Device
intervention name: Cotton Gauze
arm group label: Cotton Gauze
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Dr. Mohmmad Kabeer
role: Principal Investigator
affiliation: Malabar Institute of Medical Sciences
facility: 
country: India
responsible party type: Sponsor
mesh term: Hemorrhage
mesh term: Hemostatics
sharing ipd: No