Nasal Septal Perforation Closure Using a 3-dimensional Fabricated Polycaprolactone Nasal Mesh
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Mean Change in Post-operative healing of septal perforation
研究概览
简要总结
The goal of this clinical trial is to investigate if a 3-dimensional fabricated nasal mesh works to close nasal septal perforations. Under general anesthesia, during nasal septal perforation repair surgery, the investigator will place the mesh between the elevated mucoperichondrial flaps opposite the site of the perforation and confirm its original position at both sides under nasal endoscope. Endoscopic examination for septal mucosa status will be done monthly for a three months follow up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 58 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing nasal septal perforation repair surgery.
排除标准
- •Patients with known allergy to polycaprolactone.
- •Pregnancy or lactation.
结局指标
主要结局
Mean Change in Post-operative healing of septal perforation
时间窗: for a three months follow up period
Endoscopic evaluation of nasal septal mucosa status will be classified as complete bilateral healing, complete unilateral healing, no healing, and perforation.
次要结局
- Postoperative complications(for a three months follow up period)
研究者
Mohamed Hossam Sebaey
Assistant lecturer of otorhinolaryngology
Helwan University