A study comparing two brands of Bonewax for controlling bleeding from bone edges, when breast bone is cut during cardiovascular surgeries
- Conditions
- Health Condition 1: I248- Other forms of acute ischemic heart disease
- Registration Number
- CTRI/2022/03/041192
- Lead Sponsor
- Healthium Medtech Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 92
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method