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Evaluating the Effectiveness of Axiostat Hemostatic Dressing Material Versus Conventional Method of Hemostasis and Healing of Extraction Wounds in Patients on Oral Anti-Platelet Drugs - A Comparative Study

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ClinicalTrials.gov Identifier: NCT03108365
Recruitment Status : Completed
First Posted : April 11, 2017
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
Axio Biosolutions Pvt. Ltd.

Brief Summary:
The rationale of this study was to evaluate the efficacy of Axiostat hemostatic dental dressing in achieving hemostasis post-extraction and determining its effect on pain and healing of the extraction wound, compared to control, i.e. conventional method of extraction in patients on oral anti-platelet therapy.

Condition or disease Intervention/treatment Phase
Tooth Extraction Device: Axiostat Device: Cotton Gauze Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating the Effectiveness of Axiostat Hemostatic Dressing Material Versus Conventional Method of Hemostasis and Healing of Extraction Wounds in Patients on Oral Anti-Platelet Drugs - A Comparative Study
Actual Study Start Date : December 19, 2014
Actual Primary Completion Date : March 24, 2016
Actual Study Completion Date : March 24, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Axiostat

Size: 1 x 1 cm

Chitosan based haemostatic dressing

Device: Axiostat

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.

Axiostat® stops moderate to severe bleeding due to cuts, abrasions, lacerations, venous/arterial punctures and more. 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.

Other Name: Chitosan haemostatic dressing

Active Comparator: Cotton Gauze
Size: 1 x 1 cm
Device: Cotton Gauze
Size: 1 x 1 cm




Primary Outcome Measures :
  1. Time to achieve haemostasis [ 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. Pain & Healing Scale [ Time Frame: Upto 1 Day ]
    Patients comfort level as assessed by verbal inquiry after completion of procedure.



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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria

  • Patients undergoing multiple tooth extractions aged b/w 35- 70 years and with INR values ≤ 3.5 (1-3.5)
  • If present, sugar level should be under control

Exclusion criteria

  • Patients undergoing a single tooth or multiple extractions in same quadrant; and those with an allergy to seafood.

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): NCT03108365


Sponsors and Collaborators
Axio Biosolutions Pvt. Ltd.
Investigators
Principal Investigator: Dr. Tejraj Kale KLE Dental College, Belgaun

Responsible Party: Axio Biosolutions Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT03108365     History of Changes
Other Study ID Numbers: ABPL/004
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Hemostatics
Chitosan
Platelet Aggregation Inhibitors
Coagulants
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Chelating Agents
Sequestering Agents