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临床试验/CTRI/2026/01/100793
CTRI/2026/01/100793尚未招募不适用

Efficacy of Autologous Platelet Rich Plasma Versus Platelet Rich Fibrin Augmented Tympanoplasty: A Randomized comparative study of graft uptake, hearing improvement and Complications in Adult Patients Of CSOM in A tertiary Care Centre in Jharkhand.

Multi-Disciplinary Research Unit1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2026年2月6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
36
试验地点
1

研究概览

简要总结

This study is a randomized participant- and outcome-assessor-blind, parallel-group trial of the efficacy of autologous platelet-rich plasma versus platelet-rich fibrin-augmented tympanoplasty, comparing graft uptake, hearing improvement, and complications in CSOM patients. It will be conducted atMGM Medical College and Hospital, Jamshedpur, Jharkhand. The primary outcome measure will be graft uptake, which will be checked at 3 weeks, 6 weeks, and 3 months after surgery. The secondary outcome will be a postoperative hearing improvement assessment at 3 months.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor 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

  • 1.Cases of chronic otitis media [COM], inactive mucosal disease with central perforation and conductive hearing loss in the age group of 18–55 years of both genders.
  • 2.Dry ear without discharge for at least 6 to 8 weeks 3.Hearing loss will be less than 60 dB.
  • 4.Patients consented for study.

排除标准

  • 1.Age less than 18 years and more than 55 years.
  • 2.Active ear disease.
  • 3.Total perforation.
  • 4.Marginal perforation.
  • 5.Tympanosclerosis.
  • 6.Cholesteatoma.
  • 7.Otosclerosis.
  • 8.Atopic ear conditions.
  • 9.Middle ear mucosa congested or polypoidal.
  • 10.Revision surgery.

研究者

发起方
Multi-Disciplinary Research Unit
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Nihar Topno

Mahatma Gandhi Memorial Medical College and Hospital, Jamshedpur

研究点 (1)

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