跳至主要内容
临床试验/CTRI/2019/02/017468
CTRI/2019/02/017468招募中1 期

A Randomised controlled trial on the efficacy of topical application of autologous Platelet Rich Plasma(PRP) on graft uptake rate in adults undergoing Type 1 Tympanoplasty for inactive COM mucosal disease

Dr Rakesh Datta1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年2月18日最近更新:

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
Tympanoplasty Graft Uptake Rate

研究概览

简要总结

Chronic Otitis Media (COM) is a common ailment in the country and a leading cause of treatable deafness. It is defined as chronic inflammation of the mucosal lining of the middle ear cleft. In the mucosal type of COM, there is a permanent perforation of pars tensa. Surgery in the form of Tympanoplasty is the standard of care of such patients. A common cause of failure of this surgery includes graft failure. Platelet-rich plasma (PRP) is emerging biotechnology and a simple and minimally invasive method to obtain a high concentration of autologous growth factors at sites of healing. The usage of PRP as a topical packing material in Type 1 Tympanoplasty has been reported to enhance the graft uptake and closure rate of perforation as compared to traditional method. However, the data available is limited and no properly conducted RCTs are available to provide evidence of this adjuvant to surgery.

Accordingly, it is hypothesised that using autologous PRP as an adjuvant to standard treatment (type 1 Tympanoplasty) would enhance healing rates and minimise graft failures. The present study will get the much-needed level of evidence to prove a simple and efficacious adjuvant to improve outcomes of this common disorder.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.All cases of Chronic Otitis Media(COM) Mucosal type needing Type 1 tympanoplasty 2.Dry central perforation from last 3 months 3.Healthy middle ear mucosa.

排除标准

  • 1.COM Squamous 2.Active ear discharge 3.Ossicular chain defect/pathology 4.Presence of overt complications of COM 5.Revision surgery of COM.

结局指标

主要结局

Tympanoplasty Graft Uptake Rate

时间窗: 03 Months Post operative

次要结局

  • Hearing loss as judged by Pure TOne audiometry(03 months post operative)

研究者

发起方
Dr Rakesh Datta
申办方类型
Other [Principal investigator]

研究点 (1)

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