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

Percutaneous Coronary Intervention Clinical Trial

— AHD  

Official title:

Safety and Efficacy of Axiostat® Hemostatic Dressing on Radial Access After Percutaneous Procedure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02837744
• Other study ID #: ABPL/002
• Secondary ID: U1111-1185-5780C
• Status: Completed
• Start date: September 2016
• Est. completion date: November 2017

Study information

• Verified date: February 2021
• Source: Axio Biosolutions Pvt. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Angiography
• Angioplasty
• Percutaneous Coronary Intervention

Intervention

Device:
• Axiostat®
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.

Locations

Country	Name	City	State
India	Care Institute of Medical Sciences,Nr. Shukan Mall, Off Science City Road,Sola	Ahmedabad	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
Axio Biosolutions Pvt. Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 Day
Secondary	Quantity of Product Used	Number of Axiostat® required to achieve hemostasis. Unit of measurement is number.	1 Day
Secondary	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	1 Day
Secondary	Number of Participants With Allergy/Skin Irritation and Hematoma Formation	Observing occurrence of Allergy/Skin Irritation at the puncture site; 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.	Upto 2 Days
Secondary	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.	Upto 2 Days
Secondary	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.	1 day