Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: VELNEZ: VELNEZ is a biodegradable composite that fragments within few days on application and intended as nasal pack.
Control Intervention1: NA: NA
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: 1. 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. Subject 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. Subject with a history of postoperative recurrent rhino sinusitis and subjects with bleeding diathesis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of population having failure to cease haemorrhage within 20 minutes of VELNEZ application (as a nasal pack), will be presented in frequency with percentages w.r.t. time. For evaluation of tolerability, the number of subjects with bleeding status â??Haemorrhage controlledâ?? or â??Haemorrhage sustainedâ?? will be considered for effectiveness of device.Timepoint: 20minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢Proportion of population having moderate pain â?¢Proportion of population having moderate obstruction â?¢Proportion of population having infection at site of VELNEZ application. â?¢Proportion of population having no adhesion. â?¢ Proportion of population having Pressure effect due to packing â?¢ Proportion of population having difficulty in swallowing â?¢ Proportion of population having sleep disturbance â?¢ Proportion of population having fluid discharge volumeTimepoint: Follow up | — |
Countries
India
Contacts
Public ContactDr Rajan Datt
Datt Mediproducts Pvt. Ltd.
Outcome results
None listed