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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Axiostat | Experimental | Size: 1 x 1 cm Chitosan based haemostatic dressing |
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| Cotton Gauze | Active Comparator | Size: 1 x 1 cm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain & Healing Scale | Patients comfort level as assessed by verbal inquiry after completion of procedure. | Upto 1 Day |
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Tejraj Kale | KLE Dental College, Belgaun | Principal Investigator |
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| Label | URL |
|---|---|
| Publication in Journal of Contemporary Dental Medicine | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 17, 2019 | |
| Unrelease | Jul 24, 2019 | |
| Release | Jul 24, 2019 |
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|
|
| Cotton Gauze | Device | Size: 1 x 1 cm |
|
| Unrelease | Jul 25, 2019 |
| Release | Jul 25, 2019 |
| Reset | Sep 5, 2019 |
| Release | Oct 5, 2021 |
| Reset | Nov 1, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 17, 2019 | Jul 24, 2019 | |||
| Jul 24, 2019 | Jul 25, 2019 | |||
| Jul 25, 2019 | Sep 5, 2019 | |||
| Oct 5, 2021 | Nov 1, 2021 |