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临床试验/CTRI/2020/04/024416
CTRI/2020/04/024416已完成不适用

Efficacy of Autologous Platelet-rich plasma on Graft Uptake in Myringoplasty : A Single Blinded Randomized Control Trial

Mahatma Gandhi Medical College and Research Institute1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2020年6月4日最近更新:
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试验速览

阶段
不适用
状态
已完成
入组人数
76
试验地点
1
主要终点
Age,sex,graft uptake, percentage of perforation closure, audiology outcome
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is done to assess the Efficacy of Autologous platelet rich plasma on Graft Uptake in Myringoplasty in terms of percentage of perforation closure and audiological outcome. All patients with chronic suppurative otitis media between 18-55years of age will be included in the study to attain a sample size of 76 over a period of 18 months.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)（—）
性别
All

入选标准

  • •Diagnosis of chronic suppurative otitis Media.

排除标准

  • •Patients with active infection, attico-antral disease, chronic granulomatous disease and tumors of the ear, co-morbidities like uncontrolled diabetes, previous history of Myringoplasty or mastoidectomy , contraindication to general anesthesia, patient who smoke.

结局指标

主要结局

Age,sex,graft uptake, percentage of perforation closure, audiology outcome

时间窗: 3rd and 6th month

次要结局

  • Graft uptake, percentage of perforation closure, audiological outcome(3rd and 6th month)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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