Health Condition 1: H748- Other specified disorders of middle ear and mastoid
Conditions
Interventions
Intervention1: VELNEZ: VELNEZ is a sponge based nasal dressing used after surgery. The dressing is Fragmentable, and biocompatible device.
Control Intervention1: None: Single arm study with no, Compar
Sponsors
Datt Mediproducts Pvt Ltd,
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subject eligible for use of VELNEZ as a nasal pack post- nasal surgery. 2. Male and female in an age group of 18 to 80 years, both included. 3. Subjects who can provide written informed consent for participation in the study. 4. Subjects who allow their data to be collected for the study at predefined follow-up periods.
Exclusion criteria
Exclusion criteria: 1.Subject who are unable to be treated with VELNEZ as a nasal packing post-surgery. 2. Subject who cannot provide written informed consent for study data collection. 3. Subjects unwilling or unable to comply with the postoperative visits necessary for data collection. 4. Subject with an active infection at the site of surgery. 5. Subject with a history of asthma. 6. Subject who are on aspirin/ anti-platelet drugs. 7. Hypertensive subjects. 8. Subjects who have a history of allergic (Hypersensitive) reactions with any of the ingredients of the device. (i.e Chitosan, Gelatin and Psyllium husk) 9. Subject with bleeding disorders. 10. Any medical condition that, in the opinion of the investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study). 11. Subjects with severe inflammation of nasal passages/ sinus cavities. 12. Subjects with a history of prospective recurrent rhino sinusitis and subjects with bleeding diathesis. 13. Subject found positive for serology. 14. Subject on immunosuppressive drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study participants who achieve complete hemostasis within 10 minutes of device application, without any associated adverse events.Timepoint: 10 minutes of the device application, without any associated adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| Study participants who achieve complete participants within 20 minutes of device application, without any associated adverse events. Device fragmentation time in days among all study participants treated with VELNEZ nasal packs. Study participants having moderate pain. Study participants experiencing moderate pressure on the surgery site. Study participants experiencing nasal obstruction, other than the device. Study participants showing signs of infection at the site of VELNEZ application. Study participants showing no adhesion to the nasal mucosa on the day of surgery. Study participants having fluid raised discharge from the nasal cavity.Timepoint: 14 days ± 2 days from surgery | — |
Countries
India
Contacts
Public ContactDr Pankaj Bablani
Datt Mediproducts Pvt Ltd
Outcome results
None listed