Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: VELNEZ a nasal pack: is a biodegradable composite that fragments within few days on application and intended as nasal pack.
Duration of trial is 1 year.
Control Intervention1: Not appli
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 planned nasal surgeries such as septoplasty, turbinoplasty, polyp and other nasal surgery. 2. Male and female children in the age group of 5 to 17 years. (Both Included) 3. Subjects whose parents or legally authorized representatives (LAR) can provide written informed consent and, where applicable, subjects who can provide assent in accordance with regulatory requirements. 4. Subjects whose parents or legally authorized representatives (LAR) are willing to allow the collection of their child s study data at predefined follow-up periods.
Exclusion criteria
Exclusion criteria: 1. Subjects who are unable to be treated with VELNEZ as a nasal packing in routine clinical practice following planned surgery. 2. Subjects whose parents or legally authorized representatives (LAR) cannot provide written informed consent, or subjects unable to provide assent where applicable. 3. Subjects testing positive for HIV, HBsAg, or HCV. 4. Subjects unwilling or unable to comply with the necessary postoperative visits for data collection. 5. Subjects with an active infection at the surgical site. 6. Subjects with a history of unstable asthma. 7. Subjects currently on aspirin or antiplatelet therapy, or those with bleeding disorders. 8. Hypertensive subjects. 9. Subjects with a history of allergic (hypersensitivity) reactions to any ingredients of the device (VELNEZ) such as Chitosan, Gelatin, or Psyllium husk. 10. Subjects with any medical condition that, in the opinion of the investigator, would make them unsuitable for inclusion (e.g., chronic, relapsing, or hereditary diseases that may interfere with the study outcomes). 11. Subjects with severe rhinosinusitis involving all paranasal sinuses, associated with Sinonasal polyposis, Allergic fungal rhinosinusitis, Gross septal deviation or spurs impinging on the ostiomeatal complex (OMC),Large concha bullosa, or Allergic turbinate hypertrophy in contact with the septum. 12. Subjects with a history of postoperative recurrent rhinosinusitis or bleeding diathesis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be achieved if the following criteria are met: 1. Study participants achieve complete cessation of reactive and secondary bleeding within 20 minutes post-application of VELNEZ. 2. Study participants tolerate the use of VELNEZ as a nasal pack, with no significant safety concerns reported during the study. Timepoint: 60 5 days from device application | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Absence of post-operative adhesions at the surgical site following the use of VELNEZ. 2. Effectiveness of VELNEZ in promoting coagulation as assessed through clinical observation. 3. Monitoring & reporting of any adverse events associated with the application of VELNEZ throughout the study. 4. Evaluation of pain levels throughout the study 5. Change in the Parameters assessed by endoscopy examination. 6. Assessment of changes in Nasal Obstruction Symptom Evaluation (NOSE score) to determine improvements in nasal symptoms & overall quality of life.Timepoint: 60 5 days from device application | — |
Countries
India
Contacts
Public ContactPANKAJ BABLANI
Datt Mediproducts Pvt. Ltd.
Outcome results
None listed