A study to assess the safety and tolerability of VELNEZ nasal pack after surgery of nose
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2018/12/016535
- Lead Sponsor
- Datt Mediproducts Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
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.
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of population having failure to cease haemorrhage within 20 <br/ ><br>minutes of VELNEZ application (as a nasal pack), will be presented in <br/ ><br>frequency with percentages w.r.t. time. For evaluation of tolerability, the <br/ ><br>number of subjects with bleeding status â??Haemorrhage controlledâ?? or <br/ ><br>â??Haemorrhage sustainedâ?? will be considered for effectiveness of device.Timepoint: 20minutes
- Secondary Outcome Measures
Name Time Method â?¢Proportion of population having moderate pain <br/ ><br>â?¢Proportion of population having moderate obstruction <br/ ><br>â?¢Proportion of population having infection at site of VELNEZ application. <br/ ><br>â?¢Proportion of population having no adhesion. <br/ ><br>â?¢ Proportion of population having Pressure effect due to packing <br/ ><br>â?¢ Proportion of population having difficulty in swallowing <br/ ><br>â?¢ Proportion of population having sleep disturbance <br/ ><br>â?¢ Proportion of population having fluid discharge volumeTimepoint: Follow up