Health Condition 1: H73- Other disorders of tympanic membrane Health Condition 2: H73- Other disorders of tympanic membrane
Conditions
Interventions
Intervention1: VELNEZ®: VELNEZ® is a biodegradable composite dressing, designed to disintegrate within a few days of its application.
Control Intervention1: Gelatin based dressing: A Sterile Compres
Sponsors
Datt Meproducts Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: The participants must meet all the following criteria: 1. Male and female participants in the age group of 18 to 65 years. (Both Included). 2. Participant is confirmed diagnosis of inactive Chronic Suppurative Otitis Media (CSOM mucosal disease type). 3. Participant for the use of ear dressing pack (either VELNEZ® or Gelatin based dressing) in routine clinical practice after a planned otologic surgery for middle ear. 4. Participant who can provide informed consent form in writing or through his LAR. 5. Participants who are able and willing to comply with all study procedures and allow their study data to be collected at pre-defined follow-up period/ time and used for study objectives.
Exclusion criteria
Exclusion criteria: The Participants must not meet any of the following criteria: 1. Participants who are unable to be treated with either VELNEZ® or Gelatin based dressing in routine clinical practice after a planned middle ear surgery. 2. Participant with a sign of active infection at the site of surgery [Presence of active middle ear infection or otorrhea (ear discharge).] 3. Participant having history of previous ear surgery on the same ear planned for the study procedure. 4. Participant with uncontrolled cholesteatoma, malignant otologic tumors, complications of chronic ear disease. 5. Participation in another interventional clinical trial within 30 days prior to screening or during the study period. 6. Pregnant and nursing women. 7. Participant with uncontrolled hypertension. 8. Participants who have a history of allergy (Hypersensitive) reactions with any of the ingredients of the device (VELNEZ® / Gelatin based dressing) i.e., Chitosan, Gelatin and Psyllium husk etc. 9. Participant with bleeding disorders or is on anticoagulants or antiplatelet medications (e.g., warfarin, clopidogrel, NOACs). 10. Any medical condition that, in the opinion of the investigator, would make the participant unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study) or Presence of severe systemic illness like cardiovascular disease, liver dysfunction or psychiatric illness. 11. Participant with history of postoperative recurrent infections and participants with bleeding diathesis. 12. Participant testing positive for serological markers indicating systemic infection (e.g., HIV, hepatitis B/C). 13. Participant with medical conditions known to impair healing, including: • Uncontrolled diabetes mellitus. (HbA1c > 8%) • Severe immunosuppression (Other than HIV/AIDS) • Chronic systemic steroid use ( >10 mg/day of prednisone or equivalent) • Active malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs) within 90 days post-surgery.Timepoint: 90 ± 5 Days post surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Change from baseline in Pure Tone Audiometry (PTA) parameters, including air-conduction thresholds & airâ??bone gap, assessed at Day 30, Day 60, & Day 90 post-surgery. â?¢ Proportion of subjects demonstrating normal or improved middle-ear healing status, as assessed by standardized otoscopy findings & Impedance Audiometry parameters, on day 60 & 90. â?¢ Proportion of participants achieving successful graft uptake, & granulation in the external auditory canal, defined as complete tympanic membrane closure, as assessed at Day 15, Day 30, Day 60, & Day 90 post-surgery. Timepoint: 90 ± 5 days post surgery | — |
Countries
India
Contacts
Public ContactDr Pankaj Bablani
Datt Mediproducts Pvt Ltd
Outcome results
None listed