Comparison of the outcomes of gel foam myringoplasty with hyaluronic acid myringoplasty in mucosal chronic otitis media.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- 1.To compare reduction in size of perforation of tympanic membrane after myringoplasty before or after surgery between gel foam myringoplasty and hyaluronic acid myringoplasty.
研究概览
简要总结
Hyaluronic acid is natural high molecular weight substance has the property of tissue repair and inflammation.It stimulates the healing of tympanic membrane .
Study compares the healing of tympanic membrane perforation with hyaluronic acid and gel foam myringoplasty.
This is non randomised experimental study .
Study analyses outcome of closure of tympanic membrane ,difference in pure ton average , complications and effects of procedure .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 12.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Inactive chronic otitis media with medium or large tympanic membrane 2.Central perforation of pars tensa 3.Age above 12 years 4.Non healing traumatic perforation.
排除标准
- •1.Marginal perforation in pars tensa 2.Pus or granulation in middle ear 3.Stenotic external auditory canal 4.Squamosal chronic otitis media 5.Tympanosclerosis 6.Immunocompromised patients 7.Complicated chronic otitis media 8.Non functional eustachian tube 9.Ossicular erosion and discontinuity.
结局指标
主要结局
1.To compare reduction in size of perforation of tympanic membrane after myringoplasty before or after surgery between gel foam myringoplasty and hyaluronic acid myringoplasty.
时间窗: Ear examination done at 15 days,1 month and 3 month.Pure tone audiometry test done at 1 month and 3 month follow up
2.To compare hearing gain or loss after procedure between 2 groups
时间窗: Ear examination done at 15 days,1 month and 3 month.Pure tone audiometry test done at 1 month and 3 month follow up
3.To estimate approximate time taken for healing of tympanic membrane .
时间窗: Ear examination done at 15 days,1 month and 3 month.Pure tone audiometry test done at 1 month and 3 month follow up
次要结局
- 1.Ear discharge,infection after procedure(2.Pain in ear canal after procedure)
研究者
Dr Amrith Smirk
Karnataka Medical College and Research Institute