Health Condition 1: I248- Other forms of acute ischemic heart disease
Conditions
Interventions
Intervention1: Truwax Bonewax: Bonewax is a sterile mixture of beeswax, paraffin wax and isopropyl palmitate which is used to control bleeding when the sternum is cut during cardiovascular surgeries.
Sponsors
Healthium Medtech Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female subject aged 18-70 years, scheduled for sternotomy, for surgical procedures on heart, great vessels and mediastinal lesions 2. Subject who has given written informed consent
Exclusion criteria
Exclusion criteria: 1. Subject with a history of median sternotomy 2. Subject not requiring usage of Bonewax to stop bleeding from the bone exposed by the sternotomy 3. ASA-V classified subject 4. Subject having active infection at or around the skin incision site 5. Subject with HbA1c more than 10 6. Subject who is pregnant or lactating 7. Subject with history of allergy to bee wax or similar products 8. Subject with history of bleeding disorders 9. Subject who is already participating in another cardiovascular or similar study or have received an experimental drug or have used an experimental medical device within 30 days prior to the planned start of procedure 10. Subject unlikely to comply with surgical procedure or complete the scheduled follow up visit, in the opinion of investigator 11. Employee 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 12. Subject with mental disorder, learning disability, or language barrier 13. Other indication-based exclusion, in opinion of investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the rate of sternal dehiscence after application of Truwax® (Healthium) and Ethicon® bone wax (Johnson & Johnson) in subjects undergoing median sternotomy closureTimepoint: Day 0, Day 3, Day 4 to 15, Week 4to6, Week 12, Week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Average time to sternal hemostasis 2. To assess overall intraoperative handling 3. Surgical site bleeding, postoperative wound healing, incisional pain post sternotomy, other postoperative complications of median sternotomy closure viz. amount of postoperative drainage, bleeding, blood transfusion requirement, superficial and deep sternal wound infection 4. To investigate the re-exploration (resternotomy) and all-cause mortality rates 5. To investigate subject satisfaction and health-related quality of life (HRQoL) post-sternotomy. 6. To assess the amount of time subject takes to return back to work and to normal day to day activities 7. To evaluate material problems and other adverse eventsTimepoint: Day 0, Day 3, Day 4 to 15, Week 4to6, Week 12, Week 26 | — |
Countries
India
Contacts
Public ContactDr Ashok Kumar Moharana
Healthium Medtech Limited
Outcome results
None listed