Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: VELNEZ Nasal pack: VELNEZ is a haemostatic medical device as per list of Medical Device under provision of Sub rule (1)
Rules-4 of the Medical Device Rules – 2017
maximum duration of t
Sponsors
Datt Mediproducts Pvt. Ltd.
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Favorable endpoint would be considered to have occurred if following composite endpoints are met: • Study participants who achieve complete hemostasis with 20 minutes without any associated adverse events. • Study participants who achieve degradation of the dressing pack, within 6 days without any associated adverse eventsTimepoint: 6 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Study participants having moderate pain. Study participants having moderate obstruction. Study participants having infection at 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: 25 days | — |
Countries
India
Contacts
Public ContactDr Pankaj Bablani
Datt Mediproducts Pvt. Ltd.
Outcome results
None listed