A post marketing surveillance (PMS), single centric study to evaluate safety and tolerability of VELNEZ asa space occupying dressing pack after ear surgery.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- • Study participant who does-not achieve disintegration of the dressing/ ear plug within 49 days.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
• Study participant who does-not achieve disintegration of the dressing/ ear plug within 49 days.
时间窗: 60 days
• Study participants who does-not achieve complete hemostasis with 20 minutes.
时间窗: 60 days
• Study participant whose dressing got removed before the study period.
时间窗: 60 days
次要结局
- • Proportion of population having moderate pain.(• Proportion of population having infection at surgery site.)