Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Trulene�® sutures: Trulene�® (Monofilament polypropylene Healthium) sutures
Control Intervention1: Prolene�® sutures: Prolene�® (Monofilament polypropylene Johnson & Johnson) s
Sponsors
Healthium Medtech Pvt Ltd formerly Sutures India Pvt Ltd
Eligibility
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the performance of Trulene (Healthium) and Prolene (J & J) polypropylene sutures with respect to cumulative incidence of of major adverse cardiac and cerebrovascular events (MACCE)Timepoint: 26 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of individual components of MACCE for duration of study 2. Frequency of repeat revascularization (due to suture bleeding, needle bleeding) 3. Overall intraoperative handling between two sutures 4. Overall subject satisfaction score and Quality of Life 5. Tissue reaction, material problems and other adverse events among the two groupsTimepoint: 26 weeks | — |
Countries
India
Contacts
Public ContactDr Ashok Kumar Moharana
Healthium Medtech Pvt.Ltd. (formerly Sutures India Pvt. Ltd.)
Outcome results
None listed