跳至主要内容
临床试验/CTRI/2024/07/070204
CTRI/2024/07/070204尚未招募不适用

A study to compare the outcomes of Type 1 Tympanoplasty with the Use of Platelet Rich Fibrin versus Platelet Rich Plasma

Dr Vanshika Singhal1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年7月22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
40
试验地点
1
主要终点
To compare the graft uptake in type 1 tympanoplasty using Temporalis Fascia with PRF and with the application of PRP

研究概览

简要总结

The study " A study to compare the outcomes of Type 1 Tympanoplasty with the use of Platelet Rich Fibrin versus Platelet Rich Plasma " will be Conducted in department of Otorhinolaryngology , Varun Arjun Medical College and Rohilkhand Hospital, Banthra, Shahjahanpur, Uttar Pradesh 242307

A. The study will be conducted on subjects having tympanic membrane perforation attending the

Outpatient clinic in department of Otorhinolaryngology , Varun Arjun Medical College and

Rohilkhand Hospital, Banthra, Shahjahanpur, Uttar Pradesh based on inclusion and exclusion

Criterias

B. All patients selected for the study will undergo detailed history taking and written informed

Consent

C. Otorhinolaryngology assessment

D. Laboratory assessment

E. Patients will be admitted one day before the surgery

F. Patients will be allocated randomly into 2 groups

Group A :- Patients undergoing Type 1 Tympanoplasty with Platelet Rich Fibrin

Group B :- Patients undergoing Type 1 Tympanoplasty with  Platelet Rich Plasma

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
12.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients admitted and willing for the procedure Patients with Chronic Otitis Media Tubotympanic Type Patients with conductive hearing loss less than 40db Dry ear for atleast 6 weeks.

排除标准

  • Patients with Uncontrolled DM SHTN Bleeding Diathesis CAD Patients with mixed hearing loss.

结局指标

主要结局

To compare the graft uptake in type 1 tympanoplasty using Temporalis Fascia with PRF and with the application of PRP

时间窗: Once weekly for one month | Fortnightly for three months | Six months | ELVE MONTHS

次要结局

  • To compare the hearing outcomes in type 1 tympanoplasty using Temporalis Fascia with PRF & with the application of PRP(To assess the complications of applications of PRF & PRP in type 1 tympanoplasty)

研究者

发起方
Dr Vanshika Singhal
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr VANSHIKA SINGHAL

Varun Arjun Medical College and Rohilkhand Hospital

研究点 (1)

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