A post marketing surveillance study to check safety and tolerability of a nasal pack (VELNEZ) after a nasal surgery in pediatric patients.

Phase 4

Completed

• Conditions: Health Condition 1: O- Medical and Surgical

• Registration Number: CTRI/2023/02/049831
• Lead Sponsor: Datt Mediproducts Pvt. Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Subject eligible for the use of VELNEZ as a nasal pack in routine clinical practice after a planned surgery (Either for septoplasty or turbinoplasty)

2. Male and female children in the age group of 5 to 17 years. (Both Included)

3. Subject’s parents (LAR Legally authorized representative) who can provide

informed written consent i.e., Child Assent form.

4. Subject’s parents (LAR) who are willing to provide their child study data to be

collected at pre-defined follow-up period/ time and used for study objectives.

Exclusion Criteria

1. Subject who are unable to be treated with the VELNEZ as a nasal packing in

routine clinical practice after a planned surgery.

2. Subject’s parents (LAR) who cannot provide informed written, Child Assent form

for data collection.

3. Subject found positive for HIV, HBsAg and HCV.

4. Subject unwilling or unable to comply with the postoperative visits necessary for

data collection.

5. Subject with an active infection at the surgery site.

6. Subject with a history of asthma.

7. Subject who are on aspirin or anti-platelet drugs therapy and have bleeding

disorder.

8. Hypertensive subjects.

9. Subjects who have a history of allergy (Hypersensitive) reactions with any of the

ingredients of the device (VELNEZ) i.e., Chitosan, Gelatin and Psyllium husk etc.

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. Subject with a history of postoperative recurrent rhino sinusitis and subjects

with bleeding diathesis.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Favorable endpoint would be considered to have occurred if following composite <br/ ><br>endpoints are met: <br/ ><br>• Study participants who achieve complete hemostasis with 20 minutes without <br/ ><br>any associated adverse events. <br/ ><br>• Study participants who achieve degradation of the dressing pack, within 6 days <br/ ><br>without any associated adverse eventsTimepoint: 6 days

Secondary Outcome Measures

Name	Time	Method
Study participants having moderate pain. <br/ ><br>Study participants having moderate obstruction. <br/ ><br>Study participants having infection at 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: 25 days