Health Condition 1: H65-H75- Diseases of middle ear and mastoid
Conditions
Interventions
Intervention1: VELNEZ : VELNEZ is a single timed used dressing pack designed to be placed in the ear canal to stop ear-bleeding, post ear surgery.
Control Intervention1: None: None
Sponsors
Datt Mediproducts Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject for the use of VELNEZ as a dressing pack in a routine clinical practice after a planned otologic surgery. (Tympanoplasty or Myringoplasty or any other middle ear surgeries) 2. Male and female in the age group of 18 to 60 years, (Both Included). 3. Subjects who can provide informed consent form in writing or through his/her LAR. 4. Subjects who allow their study data to be collected at pre-defined follow-up period/ time and used for study objectives.
Exclusion criteria
Exclusion criteria: 1. Subject who are unable to be treated with the VELNEZ as a dressing packing in routine clinical practice after a 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 a sign of active infection at the site of surgery. 5. Subject with uncontrolled cholesteatoma, malignant tumors, complications of chronic ear disease. 6. Subject who are on aspirin or anti-platelet drugs therapy. 7. Pregnant and nursing women. 8. Subject with uncontrolled hypertensive subjects. 9. Subjects who have a history of allergy (Hypersensitive) reactions with any of the ingredients of the device (VELNEZ ) i.e., Chitosan, Gelatin and Psyllium husk etc. 10. Subject with bleeding disorders. 11. 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). 12. Subject with history of postoperative recurrent infections and subjects with bleeding diathesis. 13. Subject found to be positive in serology. 14. Subject on immunosuppressive drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence of adverse events reported that directly attributes to the use of VELNEZ as an ear dressing. 2. Incidence of post-operative primary and secondary bleeding during the conduct of the study. 3. Proportion of study participants achieving degradation of the VELNEZ dressing within 28 2 days post-application. 4. Proportion of study participants achieving degradation of the VELNEZ dressing within 60 5 days post-applicationTimepoint: Degradation of Ear dressing (VELNEZ) achieved in 28 2 days & 60 5 days (i,e 4 weeks & 8 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Incidence of moderate to severe pain reported by study participants by visit 09/end of study visit. 2. Occurrence of signs of infection at the site of VELNEZ application among study participants. 3. Observation of absence of adhesion of VELNEZ dressing during the removal in study participants (in case device is not dissolved within 60 5 days). 4. Measurement of increased pressure effect in the ear canal attributed to VELNEZ application during study visits.Timepoint: 2 months (60 days 5 days) | — |
Countries
India
Contacts
Public ContactPANKAJ BABLANI
Datt Mediproducts Pvt Ltd
Outcome results
None listed