Health Condition 1: J348- Other specified disorders of noseand nasal sinuses
Conditions
Interventions
Intervention1: VELNEZ: VELNEZ is intended to be used as a nasal pack after the nasal surgery (either
for Septoplasty or Turbinoplasty). It prevents adhesion by separating the compromised mucosal
sur
Sponsors
Datt Mediproducts Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject eligible to use VELNEZ as a nasal pack in routine clinical practice after planned surgery (either for septoplasty or turbinoplasty). 2. Male and female of age group between 18 to 60 years. 3. Subjects who can provide informed consent form in writing to provide data for the study. 4. Subjects who allow their data to be collected for the study at predefined follow-up periods.
Exclusion criteria
Exclusion criteria: Subject who unable to treat with the VELNEZ as a nasal packing in routine clinical practice after planned surgery. 2. Subject who cannot provide written informed consent for 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 planned surgery site. 5. Subject with a history of asthma. 6. Subject who are on aspirin or anti-platelet drugs therapy. 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 etc. 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 rhinosinusitis involving all the paranasal sinuses associated with sinonasal polyposis, allergic fungal rhinosinusitis, gross septal deviation or spurs hitching on the ostiomeatal complex (OMC) region huge concha bullosa or allergic turbinate hypertrophy in contact with septum. 12. Subjects with a history of prospective recurrent rhinosinusitis and subjects with bleeding diathesis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study participants who achieve complete hemostasis with 20 minutes without any associated adverse events.Timepoint: 20 minutes of VELNEZ application. | — |
Secondary
| Measure | Time frame |
|---|---|
| Study participants having moderate pain. Study participants having moderate obstructionStudy participants having infection at the site of VELNEZ application. Study participants with no adhesion. Study participants having Pressure effect due to VELNEZ Application. Study participants having fluid discharge volume.Timepoint: 28 days of patient follow-up (10 Visits) | — |
Countries
India
Contacts
Public ContactPANKAJ BABLANI
Sarojini Naidu Medical College
Outcome results
None listed