Care Institute of Medical Sciences,Nr. Shukan Mall, Off Science City Road,Sola
Ahmedabad, Gujarat, 380060, India
NCT Number: NCT02837744
To evaluate Safety and Efficacy of Axiostat® hemostatic dressing in terms of time to achieve hemostasis, post application complication and comfort levels of patients.
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Notify Me18 year and older
All sexes
Observational
Ahmedabad, Gujarat, 380060, India
To evaluate Safety and Efficacy of Axiostat® hemostatic dressing in terms of time to achieve hemostasis, post application complication and comfort levels of patients who have undergone radial intervention.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Axiostat Chitosan Hemostatic dressing belongs to an advanced class of wound dressing that stops bleeding within few minutes of application by providing an active mechanical barrier.
Other names: Hemostatic Dressing
Time frame: 1 Day
Time to achieve hemostasis by observing the time at which blood oozing through or from periphery of the dressing stops.
Unit of measurement is minutes.
Time frame: 1 Day
Number of Axiostat® required to achieve hemostasis. Unit of measurement is number.
Time frame: 1 Day
Number of patients will be counted (unit of measurement is number/count of patients) with re-bleeding after removal of Axiostat
Time frame: Upto 2 Days
Mode of Measurement for both of the above outcomes is Visual Observation.
Skin irritation/Allergy: Occurrence of redness at the puncture site was noted as skin irritation/allergy Hematoma: Hematoma formation at the puncture site. Hematoma was defined as presence of ecchymosis (the escape of blood into the tissues from ruptured blood vessels) at access site.
Time frame: Upto 2 Days
Level of ease of use of Axiostat was recorded. The ease of application and removal of Axiostat was rated as Excellent or Good or Fair or Poor by the Clinician / Operator Mode of Measurement is Verbal Inquiry.
Time frame: 1 day
Patients comfort level for use of dressing was recorded. The patient was required to rate the comfort level of use of dressing in terms of pain and swelling at the puncture site.
It was assessed by verbal inquiry and visual observation.
Axio Biosolutions Pvt. Ltd.
Other
Safety and Efficacy of Axiostat® Hemostatic Dressing on Radial Access After Percutaneous Procedure
Acronym: AHD
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