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

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.

Study Overview

• Status: Completed
• Conditions: Tooth Extraction
• Intervention / Treatment: Device: Axiostat; Device: Cotton Gauze

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 33 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Chitosan haemostatic dressing
Active Comparator: Cotton Gauze; Size: 1 x 1 cm	Device: Cotton Gauze; Size: 1 x 1 cm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to achieve haemostasis	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
Pain & Healing Scale	Patients comfort level as assessed by verbal inquiry after completion of procedure.	Upto 1 Day

Collaborators and Investigators

• Sponsor: Axio Biosolutions Pvt. Ltd.
• Investigators: Principal Investigator: Dr. Tejraj Kale, KLE Dental College, Belgaun

Publications and helpful links

Helpful Links

• Publication in Journal of Contemporary Dental Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2014
• Primary Completion (Actual): March 24, 2016
• Study Completion (Actual): March 24, 2016

Study Registration Dates

• First Submitted: March 30, 2017
• First Submitted That Met QC Criteria: April 10, 2017
• First Posted (Actual): April 11, 2017

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 1, 2019
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Coagulants; Chelating Agents; Sequestering Agents; Hemostatics; Chitosan
• Other Study ID Numbers: ABPL/004

Drug and device information, study documents

• 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