Outcomes of Surgical Management of Chronic Otitis Media with Silastic Sheet Graft Reinforcement - A Randomised Controlled Trial.
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- 1. Hearing outcome
研究概览
简要总结
This study is a randomized controlled trial, open blinded, studying the effect of Silastic sheet in middle ear surgeries assessing post operative hearing improvement and graft uptake in comparison to temporalis fascia graft. This study will be done for a period of 12 months and all patients from the inclusion criteria would be included in the study and randomised into two groups- Group A and Group B. In Group A, Silastic sheet would be used as a graft material. In Group B, Temporalis fascia graft would be used. Post operatively, Hearing improvement and Graft uptake would be assessed comparing the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 15.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients suffering from chronic otitis media -Patients who offered informed and written consent to undergo the surgical procedure.
排除标准
- •Presence of middle ear mucosal edema -Presence of ossicular necrosis -Cholesteatoma -Granulation tissue tympanosclerosis and -Poor eustachian tube function.
结局指标
主要结局
1. Hearing outcome
时间窗: 1. 1 month, 2 months | 2. 1 month, 2 months
2. Graft uptake
时间窗: 1. 1 month, 2 months | 2. 1 month, 2 months
次要结局
- At the end of follow-up period, to assess any complications like purulent ear discharge(One and two months post operatively to assess any complications that could arise)
研究者
Dr Sharika Sakunthala A
SRM Medical College Hospital And Research Centre