Comparing outcomes in perioperative only versus extended antimicrobial usage in tympanomastoid surgery for chronic otitis media: A randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Wound infection;Discharge from ear canal; Graft failure; adverse reaction to drug; Length of Hospital stay; revision due to failure
研究概览
简要总结
This study is randomized, double blind, parallel group, active controlled trial comparing outcomes in perioperative only versus extended antimicrobial usage in tympanomastoid surgery for active and inactive mucosal chronic otitis media that will be conducted at tertiary referal center ; Department of ENT, SDM College of Medical Sciences and Hospital, Dharwad, Karantaka, India.
The primary outcome measure will assess various parameters of infection leading surgical site infection and graft failure (re perforation) requiring revision surgery. Hence judicious and responsible antimicrobial policy can be practiced for these type of surgeries by otolaryngologists
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Active and inactive mucosal chronic otitis media.
排除标准
- •Squamosal chronic otitis media,Revision tympanomastoid surgery,Ossicular discontinuity requiring reconstruction, tympanosclerosis, Diabetes mellitus other systemic disorder.
结局指标
主要结局
Wound infection;Discharge from ear canal; Graft failure; adverse reaction to drug; Length of Hospital stay; revision due to failure
时间窗: All the primary outcomes assessed individually at 1st, 2nd and 3rd week postoperatively
次要结局
- Otoendoscopic examination(1 month)