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

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

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

Study Overview

• Status: Completed
• Conditions: Percutaneous Coronary Intervention; Angioplasty; Angiography
• Intervention / Treatment: Device: Axiostat®

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Ahmedabad, Gujarat, India, 380060
      • Care Institute of Medical Sciences,Nr. Shukan Mall, Off Science City Road,Sola

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All eligible patients who came to the institution/hospital and provided informed consent.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Axiostat®; Size: 3.5 cm X 3.5 cm	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.; Other Names: Hemostatic Dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantity of Product Used	Number of Axiostat® required to achieve hemostasis. Unit of measurement is number.	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	1 Day
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
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
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

Collaborators and Investigators

• Sponsor: Axio Biosolutions Pvt. Ltd.
• Investigators: Principal Investigator: Milan Chag, Dr., Care Institute of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: July 11, 2016
• First Submitted That Met QC Criteria: July 15, 2016
• First Posted (Estimate): July 20, 2016

Study Record Updates

• Last Update Posted (Actual): March 11, 2021
• Last Update Submitted That Met QC Criteria: February 18, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coagulants; Hemostatics
• Other Study ID Numbers: ABPL/002; U1111-1185-5780 (Other Identifier: World Health Organization); CTRI/2016/07/007115 (Registry Identifier: Clinical Trial Registry - India)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No