跳至主要内容
临床试验/CTRI/2017/04/008315
CTRI/2017/04/008315尚未招募不适用

A randomised control trial to assess efficacy of platelet rich fibrin in tympanoplasty.

Dr Nikhil Vallathukaran Mathew1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年10月4日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To assess to graft uptake following application of platelet rich fibrin.

研究概览

简要总结

This study is a randomised, single blinded, parallel group, single centre trial comparing the improved outcome with the use of platelet rich fibrin in Tympanoplasty ear surgery as compared with conventional technique without using the platelet rich fibrin.This study will be done for 15 month over 60 patients with chronic suppurative otitis media(Inactive) with no comorbidities. The primary outcome will measure the graft take up at 1st week, 1st month and 3rd month. The healing rate of of perforation and hearing improvement post tympanoplasty is also assessed at 3rd months.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
20.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Chronic Suppurative Otiti Media- Tubotympanic Disease(Inactive).

排除标准

  • Comorbities like Diabetes Mellitus, Hypertension, Bronchial Asthma, Tuberculosis.

结局指标

主要结局

To assess to graft uptake following application of platelet rich fibrin.

时间窗: At end of 1 week, 1 month and 3rd month

次要结局

  • To assess the rate of healing.(At end of 1 week,1 month and 3 month)
  • To assess the hearing improvement post tympanoplasty(At end of 3 months)

研究者

发起方
Dr Nikhil Vallathukaran Mathew
申办方类型
Other []

研究点 (1)

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