Health Condition 1: H61- Other disorders of external ear Health Condition 2: H74- Other disorders of middle ear mastoid
Conditions
Interventions
Intervention1: VELNEZ: space occupying dressing pack to be applied once during the trial. (Post surgery)
Control Intervention1: Not Applicable: N/AP
Sponsors
Datt Mediproducts Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Study participant who does-not achieve disintegration of the dressing/ ear plug within 49 days. • Study participants who does-not achieve complete hemostasis with 20 minutes. • Study participant whose dressing got removed before the study period.Timepoint: 60 days | — |
Secondary
| Measure | Time frame |
|---|---|
| • Proportion of population having moderate pain. • Proportion of population having infection at surgery site. • Population experiencing pressure effect in the ear canal, due to the application of the VELNEZ ear plug.Timepoint: 60 days | — |
Countries
India
Contacts
Public ContactDr Pankaj Bablani
Datt Mediproducts Private Limited
Outcome results
None listed