Assessing the Effectiveness of Autologous Platelet-Rich Plasma in Comparison to Conventional Myringoplasty Procedure:A Randomized Controlled Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Tympanic membrane closure success rate assessed by otoscopy and
研究概览
简要总结
Myringoplasty, a surgical procedure aimed at repairing tympanic membrane perforations, is crucial for restoring hearing and preventing middle ear infections. While conventional techniques have been the mainstay for decades, emerging evidence suggests the potential benefits of autologous platelet-rich plasma (PRP) in enhancing tissue healing and regeneration. This randomized controlled trial (RCT) aims to assess the comparative efficacy of PRP versus conventional myringoplasty in terms of surgical outcomes, hearing improvement, and complication rates. By evaluating these two approaches head- to-head, this study seeks to provide valuable insights into the potential role of PRP in optimizing myringoplasty outcomes and advancing the field of otologic surgery.
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
- 15.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •All cases of tubotympanic type of chronic suppurative otitis media with perforation of the tympanic membrane with dry ear for a period of 3 weeks before day of surgery.
- •No evidence of active infection in nose,throat or paranasal sinuses.
- •Includes patient in the age group of 15-70 years.
排除标准
- •All cases of Attico antral type of CSOM.
- •Patients with age less than 15 years and more than 70 years of age.
- •Otogenic intra cranial complications in the past.
- •External ear infective condition.
- •Per operative ossicular discontinuity, fixed foot plate.
- •Patients with evidence of focal sepsis.
结局指标
主要结局
Tympanic membrane closure success rate assessed by otoscopy and
时间窗: at 6 weeks and 3 months post surgery
tympanometry at specified follow-up intervals (e.g., 6 weeks & 3 months postsurgery).
时间窗: at 6 weeks and 3 months post surgery
次要结局
- Improvement in pure tone audiometry (PTA) thresholds,(postoperative complications (e.g.,graft displacement, infection), and patient reported)
研究者
Sharan Prakash
Aarupadai Veedu Medical College and Hospital