A study (PMS) to check and assess the safety and tolerability of a biodegradable nasal dressing (VELNEZ) after nose surgery.

Phase 4

Completed

• Conditions: Health Condition 1: J348- Other specified disorders of noseand nasal sinuses

• Registration Number: CTRI/2021/09/036437
• Lead Sponsor: Datt Mediproducts Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-03-24
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

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

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.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Study participants who achieve complete hemostasis with 20 minutes without any <br/ ><br>associated adverse events.Timepoint: 20 minutes of VELNEZ application.

Secondary Outcome Measures

Name	Time	Method
Study participants having moderate pain. <br/ ><br>Study participants having moderate obstructionStudy participants having infection at the site of VELNEZ application. <br/ ><br>Study participants with no adhesion. <br/ ><br>Study participants having Pressure effect due to VELNEZ Application. <br/ ><br>Study participants having fluid discharge volume.Timepoint: 28 days of patient follow-up (10 Visits)