Single blind, randomized study evaluating clinical equivalence of TrusteelÂ® and EthisteelÂ® surgical steel suture, for sternal closure, in subjects undergoing surgical procedures by sternotomy

Healthium Medtech Pvt Ltd0 个研究点目标入组 72 人开始时间: 待定最近更新: 2023年7月25日

试验速览

暂无简介。

•1. Male or female subjects aged 18-70 years, scheduled for median sternotomy, for surgical procedures on heart, great vessels and mediastinal lesions
•2. Subjects who have given written informed consent

•1. Subjects with a history of median sternotomy
•2. ASA-V classified subjects
•3. Subjects having active infection at or around the -skin incision site
•4. Subjects who are pregnant
•5. Subjects with history of allergy to steel or similar products
•6. Subjects with history of bleeding disorders
•7. Subjects already participating in another cardiovascular or similar study
•8. Subjects who received an experimental drug or used an experimental medical device within 30 days prior to the planned start of procedure
•9. Subjects unlikely to comply with surgical procedure or complete the scheduled follow up visit, in the opinion of investigator
•10. 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
•11. Subjects with mental disorder, learning disability, or language barrier
•12. Other indication-based exclusion, in opinion of investigator

发起方

Healthium Medtech Pvt Ltd