SILASTIC SHEET INTERPOSITIONING FOR PREVENTION OF CRANIOFACIAL PAIN SECONDARY TO HARVESTING OF TEMPORALIS FASCIA IN MYRINGOPLASTY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- To determine whether silastic sheet interpositioning has effect on reducing craniofacial pain secondary to harvesting of temporalis fascia in myringoplasty.
研究概览
简要总结
v Patients who undergo myringoplasty accompanied by temporalis fascia harvest complain of craniofacial pain in the ipsilateral temporal area during mastication or even while resting, this may arise either from direct injury to temporalis muscle or from post operative adhesions. Silastic is a known bio-inert and biofriendly material that has been extensively used as a barrier to prevent adhesion, particularly in the treatment of atelectatic tympanic membrane . This cost effective material can be conveniently cut and sized as per requirements. Therefore, in our study we are evaluating the antiadhesive effect of silastic sheet in reducing postoperative craniofacial pain after temporalis fascia harvest during myringoplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Tubo tympanic type of CSOM Ear to be operated should be dry for at least 4 weeks prior to surgery Eustachian tube function normal.
排除标准
- •Squamosal otitis media Revision ear surgeries Canal wall down mastoidectomies Compromised immunity Diabetes Preoperative craniofacial pain.
结局指标
主要结局
To determine whether silastic sheet interpositioning has effect on reducing craniofacial pain secondary to harvesting of temporalis fascia in myringoplasty.
时间窗: Days 7,15,70,90
次要结局
- To evaluate craniofacial pain following temporalis fascia grafting in myringoplasty
研究者
Dr V Srinivasa
Vinayaka Missions University: Vinayaka Missions Research Foundation (Deemed to be University)