A post marketing surveillance (PMS), single centric study to evaluate safety and tolerability of VELNEZ asa space occupying dressing pack after ear surgery.

Datt Mediproducts Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年8月21日

试验速览

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•1. Subject eligible to receive the ear plug in routine clinical practice after planned ear surgery (External and middle ear surgeries).
•2. subjects of any sex of age between 18-60 years. (Both included).
•3. Subjects who can give informed consent in writing for participation in the trial.
•4. Subjects allowing their data to be collected for the study at predefined followups.
•5. Female subject who is willing to take contraception for the entire duration of the study.

•1. Subject who cannot be treated with ear plug after planned ear surgery.
•2. Subjects who cannot provide informed consent.
•3. Subject found positive for HIV, HBsAg and HCV.
•4. Subjects unwilling or unable to comply with the postoperative visits necessary for data collection.
•5. Subjects suffering from cholesteatoma or granulations in the middle ear.
•6. Subjects suffering from complicated chronic suppurative otitis media.
•7. Subject having an active infection at the surgical site.
•8. Subjects having a history of diabetes mellitus.
•9. Subject on aspirin/anti-platelet drugs /oral anticoagulants therapy.
•10. Hypertensive subject.
•11. Pregnant females.
•12. Subjects who have a history of allergic (Hypersensitive) reactions with any of the ingredients of the device i.e., Chitosan, Gelatin and Psyllium husk etc.
•13. Concurrent participation in another clinical trial that involves an investigational drug or dressing that would interfere with this study.
•14. Subject with Immunosuppression, corticosteroids or chemotherapy.
•15. Subject with decision making impairment.
•16. Subject with a severe comorbid disorder, not expected to survive more than 12 months.

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