CTRI/2020/05/025157CompletedPhase 4
Single-blind, randomized study comparing clinical equivalence of Trulene�® and Prolene�® polypropylene sutures in elective primary coronary artery bypass graft surgery
Healthium Medtech Pvt Ltd formerly Sutures India Pvt Ltd0 sites92 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 92
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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