A study to evaluate the safety and tolerability of nasal dressing (VELNEZ) after a nasal surgery.

Recruitment & Eligibility

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 60 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

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.

Primary Outcome Measures

Name	Time	Method
Study participants who achieve complete hemostasis within 10 minutes of <br/ ><br>device application, without any associated adverse events.Timepoint: 10 minutes of the device application, without any associated adverse events.

Secondary Outcome Measures

Name	Time	Method
Study participants who achieve complete participants within 20 minutes of <br/ ><br>device application, without any associated adverse events. <br/ ><br>Device fragmentation time in days among all study participants treated with VELNEZ nasal packs. <br/ ><br>Study participants having moderate pain. <br/ ><br>Study participants experiencing moderate pressure on the surgery site. <br/ ><br>Study participants experiencing nasal obstruction, other than the device. <br/ ><br>Study participants showing signs of infection at the site of VELNEZ application. <br/ ><br>Study participants showing no adhesion to the nasal mucosa on the day of surgery. <br/ ><br>Study participants having fluid raised discharge from the nasal cavity.Timepoint: 14 days ± 2 days from surgery