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

Not Applicable

Completed

• Conditions: Tooth Extraction
• Interventions: Device: Axiostat; Device: Cotton Gauze

• Registration Number: NCT03108365
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-19
• Primary Completion: 2016-03-24
• Study Completion: 2016-03-24
• Study First Submitted: 2017-03-30
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-11
• Last Update Submitted: 2019-07-01
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Axiostat	Axiostat	Size: 1 x 1 cm Chitosan based haemostatic dressing
Cotton Gauze	Cotton Gauze	Size: 1 x 1 cm

Primary Outcome Measures

Name	Time	Method
Time to achieve haemostasis	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

Name	Time	Method
Pain & Healing Scale	Upto 1 Day	Patients comfort level as assessed by verbal inquiry after completion of procedure.