Efficacy of Secondary Obliteration of Chronically Discharging Old Radical Cavities Using S53P4 Bioactive Glass
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Number or participants with a dry ear pre- and postoperatively
研究概览
简要总结
In canal wall down surgeries, the posterior bony wall of the external auditory canal (EAC) is removed to increase exposure. The creation of a so-called radical cavity comes with several possible disadvantages, such as higher rates of postoperative otorrhea and purulence, pain, adherence to water precautions and dizziness. Secondary obliteration of the mastoid cavity and reconstruction of the posterior wall of the EAC can help alleviate these symptoms. Our goal is to study the efficacy of secondary obliteration using S53P4 bioactive glass as obliteration material. This bioactive glass has several important characteristics, such as retaining of volume over time and antibacterial effects. The main outcome will be postoperative otorrhea as indicated by the Merchant grading scale.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Old canal wall down cavity
- •Operated between 2011 and 2022
排除标准
- •Middle ear cholesteatoma
- •Previous obliteration
结局指标
主要结局
Number or participants with a dry ear pre- and postoperatively
时间窗: At 1, 3 and 5-year postoperatively.
Postoperative otorrhea as indicated by the Merchant grading system. Grade 0-1 was defined as control of infection and grade 2-3 was defined as failure.
次要结局
- Pre- and postoperative air conduction(pre-operatively, in the first 6 months following surgery and 6-12 months postoperatively)
- Pre- and postoperative air-bone gap(pre-operatively, in the first 6 months following surgery and 6-12 months postoperatively)
- The number of patients with postoperative surgical complications(First year following surgery)