Health Condition 1: null- 2. The subject has a planned nasal surgery (either for septoplasty with or without FESS or turbinoplasty) Health Condition 2: O- Medical and Surgical
Conditions
Interventions
Intervention1: VELNEZ: VELNEZ is a Biodegradable composite that fragments within few days on application intended as nasal dressing. The pain associated with the tradition nasal pack removal is comple
Sponsors
Datt Mediproducts Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age in between 18-60 years. 2. The subject has a planned nasal surgery (either for septoplasty with or without FESS or turbinoplasty). 3. Subjects who can provide informed consent form in writing and medically in a position to undergo consent and screening processes. 4. The subject is willing and able to comply with the requirements of the study protocol, including the predefined follow-up evaluations.
Exclusion criteria
Exclusion criteria: 1. Subjects with medical emergency, where treatment is more essential than the informed consent process and he or his representative deny to participate in study. 2. Subjects who cannot provide informed consent such as unconscious subjects. 3. Subjects unwilling or unable to comply with the postoperative visits necessary for data collection. 4. 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. 5. Subject has an active infection at the planned surgery site. 6. Subjects who have a history of previous septoplasty, allergy and/or asthma 7. Postoperative recurrent rhino sinusitis, patients with bleeding diathesis, 8. Subject on aspirin or anti-platelet drugs therapy. 9. hypertensive patients 10. Subjects who have a history of allergic (Hypersensitive) reactions with any of the ingredients of the device i.e Chitosan, Gelatin etc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of population, failure to cease haemorrhage after VELNEZ packing in nasal cavityTimepoint: 20 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in subject comfort level in compare of other VELNEZ/Biodegradable or Nonâ??Biodegradable nasal packs after nasal surgery in enrolled subjects.Timepoint: after surgery, at discharge, 2nd day, 4th day, 6th day, 8th day, 10th day, 2nd week, 3rd week and 4th week after Surgery | — |
Countries
India
Contacts
Public ContactDr Rajan Datt
Datt Mediproducts Pvt. Limited
Outcome results
None listed