Health Condition 1: null- All patients who will meet the study related inclusion & exclusion criteria and eligible to use VELNEZ as a nasal pack in routine clinical practice after planned nasal surgery Health Condition 2: O- Medical and Surgical Health Condition 3: O- Medical and Surgical
Conditions
Interventions
Intervention1: VELNEZ: VELNEZ is a Biodegradable composite that fragments within few days on application. It is intended as nasal pack. The pain associated with the traditional nasal pack removal is c
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, 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-upperiods.
Exclusion criteria
Exclusion criteria: 1. Subject whose nasal cavity cannot be packed with the VELNEZ as a nasal pack in routine clinical practice after planned surgery. 2. Subjects 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. Subjects who have a history of asthma 6. Subjects 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. Subjects who have 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 who have history of postoperative recurrent rhino sinusitis, subjects with bleeding diathesis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of population having failure to cease hemorrhage within 20 minutes with application of VELNEZ (as a nasal pack), will be presented in frequency with percentages w.r.t. time. For evaluation of efficacy, the number of subjects with bleeding status â??Haemorrhage controlledâ?? or â??Haemorrhage sustainedâ?? will considered for effectiveness of device.Timepoint: 20 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Proportion of population having moderate pain â?¢ Proportion of population having fluid discharge volume â?¢ Proportion of population having moderate obstruction â?¢ Proportion of population having no adhesion â?¢ Proportion of population having Pressure effect due to packing â?¢ Proportion of population having infection at site of application. â?¢ Proportion of population having difficulty in swallowing â?¢ Proportion of population having sleep disturbance Timepoint: follow up | — |
Countries
India
Contacts
Public ContactDr Rajan Datt
Datt Mediproducts Pvt. Ltd
Outcome results
None listed