A prospective, single blind, randomized study comparing clinical equivalence of TruwaxÂ® (Healthium) and EthiconÂ® bone wax (Johnson & Johnson) for sternal wound hemostasis in subjects undergoing surgical procedures by sternotomy

Healthium Medtech Limited0 个研究点目标入组 92 人开始时间: 待定最近更新: 2023年7月25日

试验速览

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•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

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