Comparative Study of Mitomycin C and Internal Nasal Septal Splint in the Treatment of Nasal Synechiae
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Recurrence or absence of synechiae
研究概览
简要总结
This study evaluates whether Mitomycin C is an effective alternative to septal splints in the treatment of nasal synechiae.
详细描述
Nasal synechiae is an important cause for the failure of many a nasal surgery. Septal splints have been widely used for the treatment of nasal synechiae, but are associated significant morbidity until removal. To the best of our knowledge there are no studies in literature comparing Mitomycin C with septal splints as an atraumatic alternative in the treatment of nasal synechiae. This is a preliminary study taken up to evaluate the therapeutic efficacy of Mitomycin C in the treatment of nasal synechiae.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with nasal mucosal synechiae due to surgical or non-surgical trauma
排除标准
- •Patients with nasal vestibular stenosis
- •Patients with nasal synechiae due to diseases like Hansen's disease, Syphilis, Rhinoscleroma, Atrophic Rhinitis etc.
研究组 & 干预措施
Mitomycin C
Cases recruited into this arm receive topical application of mitomycin c (1mg/ml)following surgical synechiolysis
干预措施: Mitomycin C (Drug)
Teflon septal splint
Cases recruited into this arm receive insertion of teflon internal nasal septal splint following surgical synechiolysis
干预措施: Teflon nasal septal splint (Device)
结局指标
主要结局
Recurrence or absence of synechiae
时间窗: 1 week, 1 month, 2 months
次要结局
- Symptoms and complications(1 week, 1 month, 2 months)