A clinical equivalence study of two polypropylene sutures (Trulene and Prolene) in elective primary coronary artery bypass graft surgery
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2020/05/025157
- Lead Sponsor
- Healthium Medtech Pvt Ltd formerly Sutures India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 92
1. Male or female subjects above 18 years, scheduled for elective primary coronary artery bypass graft surgery
2. Subjects who have given written informed consent
1. Subjects with a history of CABG
2. Subjects who require other combined valve intervention
3. Subjects having active infection at or around the skin incision site
4. Subjects with history of allergy to polypropylene or similar products
5. Subjects with history of bleeding disorders
6. Subjects already participating in another cardiovascular study
7. Subjects who received an experimental drug or used an experimental medical device within 30 days prior to the planned start of procedure
8. Subjects unlikely to comply with surgical procedure or complete the scheduled follow up visit, in the opinion of investigator
9. Employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center
10. Subjects with mental disorder, learning disability, or language barrier
11. Other indication-based exclusion, in opinion of investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method