CTRI/2023/02/049434CompletedUnknown
A post marketing surveillance (PMS), single centric study to evaluate safety and tolerability of VELNEZ asa space occupying dressing pack after ear surgery.
Datt Mediproducts Private Limited1 site in 1 country21 target enrollmentStarted: February 13, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Completed
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- • Study participant who does-not achieve disintegration of the dressing/ ear plug within 49 days.
Study Overview
Brief Summary
The adhesive properties of a dressing could lead to reactive and secondary bleeding in the ear canal, leading to post-operative infections. This ear packing is used in the external and middle ear surgery. The pain associated with removal procedures is not necessary on application of VELNEZ. Also reduces fibrosis at the same time promote healing and clotting. The study has been conducted to assess the effectiveness of a VELNEZ (space occupying dressing pack) after ear surgery on the basis of its healing rate on clinical evaluation and wound analysis.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Subject eligible to receive the ear plug in routine clinical practice after planned ear surgery (External and middle ear surgeries).
- •subjects of any sex of age between 18-60 years.
- •(Both included).
- •Subjects who can give informed consent in writing for participation in the trial.
- •Subjects allowing their data to be collected for the study at predefined followups.
- •Female subject who is willing to take contraception for the entire duration of the study.
Exclusion Criteria
- •Subject who cannot be treated with ear plug after planned ear surgery.
- •Subjects who cannot provide informed consent.
- •Subjects unwilling or unable to comply with the postoperative visits necessary for data collection.
- •Subjects suffering from cholesteatoma or granulations in the middle ear.
- •Subjects suffering from complicated chronic suppurative otitis media.
- •Subject having an active infection at the surgical site.
- •Subjects having a history of diabetes mellitus.
- •Subject on aspirin/anti-platelet drugs /oral anticoagulants therapy.
- •Hypertensive subject.
- •Pregnant females.
- •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.
- •Concurrent participation in another clinical trial that involves an investigational drug or dressing that would interfere with this study.
- •Subject with Immunosuppression, corticosteroids or chemotherapy.
- •Subject with decision making impairment.
- •Subject with a severe comorbid disorder, not expected to survive more than 12 months.
Outcomes
Primary Outcomes
• Study participant who does-not achieve disintegration of the dressing/ ear plug within 49 days.
Time Frame: 60 days
• Study participants who does-not achieve complete hemostasis with 20 minutes.
Time Frame: 60 days
• Study participant whose dressing got removed before the study period.
Time Frame: 60 days
Secondary Outcomes
- • Proportion of population having moderate pain.(• Proportion of population having infection at surgery site.)
Investigators
Study Sites (1)
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