Studying Hemostatic Effect of Axiostat® Dressing on Radial Access After Percutaneous Procedure

Axio Biosolutions Pvt. Ltd.70 enrolled

Overview

To evaluate Safety and Efficacy of Axiostat® hemostatic dressing in terms of time to achieve hemostasis, post application complication and comfort levels of patients.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Percutaneous Coronary Intervention Angiography Angioplasty

Interventions

Axiostat®DEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age greater than or equal to 18 years. 2. Patient and/or patient's legal representative and/or impartial witness has/have been informed of the nature of the study and agrees to its provision and has provided written informed consent as approved by the Ethics Committee of the investigative site. 3. Iatrogenic puncture 4. Patient who want to undergo radial intervention. 5. All puncture size must be less than 2.5cm. Exclusion Criteria: 1. Prior diagnosis of disease or medical condition affecting the ability of blood to clot (e.g., hemophilia.). 2. Patients with known sensitivity to chitosan (shellfish) used in this study. 3. Patients who, in the opinion of the Investigator, may not complete the study for any reason, e.g. Patient requiring Immediate suturing. 4. Patient is currently participating in an investigational drug or dressing study that has not yet completed its primary endpoint interferes with procedure and assessments in this trial. 5. Pregnant women. 6. Patients with hemorrhagic shock. 7. Patient having hemoglobin \< 9 g/dl.

Locations (1)

Care Institute of Medical Sciences,Nr. Shukan Mall, Off Science City Road,Sola

Ahmedabad, Gujarat, India

Outcomes

Primary Outcomes

Time to Achieve Hemostasis

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

Secondary Outcomes

Quantity of Product Used

Number of Axiostat® required to achieve hemostasis. Unit of measurement is number.

Time frame: 1 Day

Number of Patients With Re-bleeding

Number of patients will be counted (unit of measurement is number/count of patients) with re-bleeding after removal of Axiostat

Time frame: 1 Day

Number of Participants With Allergy/Skin Irritation and Hematoma Formation

1. Observing occurrence of Allergy/Skin Irritation at the puncture site 2. Observation of formation of Hematoma and/or any vascular complication after removal of Axiostat®. 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

Ease of Use of Product

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: Upto 2 Days

Patient Comfort Level

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.

Data from ClinicalTrials.gov

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