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.

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Key information

Conditions

Tooth Extraction

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Axiostat

Device

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

Cotton Gauze

Device

Size: 1 x 1 cm

Primary outcomes

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 outcomes

Pain & Healing Scale

Time frame: Upto 1 Day

Patients comfort level as assessed by verbal inquiry after completion of procedure.

Sponsors and collaborators

Lead sponsor

Axio Biosolutions Pvt. Ltd.

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Apr 11, 2017
Registry last updated: Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed