NCT03108365

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 19, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 30, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
Last Updated

July 5, 2019

Status Verified

April 1, 2017

Enrollment Period

1.3 years

First QC Date

March 30, 2017

Last Update Submit

July 1, 2019

Conditions

Tooth Extraction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Pain & Healing Scale

    Upto 1 Day

Study Arms (2)

Axiostat

EXPERIMENTAL

Size: 1 x 1 cm Chitosan based haemostatic dressing

Device: Axiostat

Cotton Gauze

ACTIVE COMPARATOR

Size: 1 x 1 cm

Device: Cotton Gauze

Interventions

AxiostatDEVICE

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.

Also known as: Chitosan haemostatic dressing
Axiostat
Cotton GauzeDEVICE

Size: 1 x 1 cm

Cotton Gauze

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

Study Officials

  • Dr. Tejraj Kale

    KLE Dental College, Belgaun

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2017

First Posted

April 11, 2017

Study Start

December 19, 2014

Primary Completion

March 24, 2016

Study Completion

March 24, 2016

Last Updated

July 5, 2019

Record last verified: 2017-04