Efficacy of Autologous Platelet Rich Fibrin (PRF) on successful closure rate in Type 1 Tympanoplasty : Open label randomized controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To study the successful closure rate (complete graft uptake and healing of perforation) in experimental group (Type 1 tympanoplasty with Platelet rich fibrin) and control group (Type 1 tympanoplasty without Platelet rich fibrin).
研究概览
简要总结
Thesis Protocol Summary
Title - “ Efficacy of Autologous Platelet Rich Fibrin (PRF) on successful closure rate in Type 1 Tympanoplasty : Open label randomized controlled trial â€
- Dr Mehul Barfa
Objectives –
Primary:
1. To study the successful closure rate (complete graft uptake and healing of perforation) in experimental group (Type 1 tympanoplasty with PRF) and control group (Type 1 tympanoplasty without PRF).
2.Secondary:
- To assess the healing time for repair of perforation in experimental group (Type 1 tympanoplasty with PRF) and control group (Type 1 tympanoplasty without PRF).
- To assess hearing outcome in terms of A-B gap closure in the experimental and control groups after six months of surgery
Justification- Use of PRF on the temporalis fascia as a graft material can have better dimensional stability, especially in large perforations. As it is a thin membrane, it does not impede sound conducting mechanism and subsequently leads to better outcome, particularly with respect to achieving an intact TM and hearing improvement .
Study design - A randomized control trial , active control, open label study.
Randomization - Systematic randomization using computer-based software. STUDY DURATION: 18 MONTHS
Sample size – Total study population – 50
Case – 25 , control – 25
Methodology – COM cases – inactive
In cases - Temporalis fascia placed beneath TM flap , platelet rich Fibrin (PRF) membrane will be placed over the tympanomeatal flap layer then gelfoam will be placed in EAC ,
In control - Temporalis fascia placed beneath TM flap , gel foam will be placed in EAC.
Patients will be followed up at 7 days , 1, 3 and 6 months and observe for Graft uptake – Full closure/ Residual perforation otoendoscopically , and note the time of healing.
And PTA will be performed at 3 and 6 months of surgery.
Autologus PRF preparations will be done from patients blood
30 ml of whole blood ,after process of centrifugation middle layer of PRF will be extracted and will be used for study .
All the data will be collected in excel sheet and
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age from 18 to 65 , inactive chronic otitis media mucosal type, hearing less than 50 db, unilateral case of chronic suppurative otitis media , Dry from last 4 weeks.
排除标准
- •Chronic otitis media squamous , Hearing loss more than 50 db , patient with active discharge , revision tympanoplasty , any co-morbidities like DM .
结局指标
主要结局
To study the successful closure rate (complete graft uptake and healing of perforation) in experimental group (Type 1 tympanoplasty with Platelet rich fibrin) and control group (Type 1 tympanoplasty without Platelet rich fibrin).
时间窗: Follow up the patients at 1,3and 6 months post intervention and observe for Graft uptake – Full closure/ Residual perforation.
次要结局
- To assess healing time in repair of perforation
研究者
Dr Mehul Barfa
AIIMS , Raipur