Platelet Rich Fibrin Augmented Tympanoplasty Versus Cartilage Tympanoplasty: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- Healing rate, or graft take rate.
研究概览
简要总结
This study was performed to compare healing and hearing outcomes of two tympanoplasty techniques, performed for patients with total or subtotal tympanic membrane perforations. The first group underwent temporalis fascia tympanoplasty, augmented with platelet rich fibrin, while the second group underwent cartilage tympanoplasty. preoperative data, operative techniques, and postoperative outcomes were analyzed.
详细描述
Two groups are included. In the platelet rich fibrin augmented tympanoplasty group, a piece of temporalis fascia is harvested and used as a graft material. A layer of platelet rich fibrin is added to improve healing process. In the cartilage tympanoplasty group, a piece of cartilage is harvested from the patient concha and used for grafting. Both groups will be compared in terms of healing and hearing. Healing is considered successful if an intact tympanic membrane is achieved withing 12 weeks follow up period. Hearing outcomes are analyzed by comparing the preoperative pure tone audiometry values with the postoperative values.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults patients older than 18 years.
- •Chronic suppurative otitis media mucosal type with total or subtotal perforation.
- •Inactive for 3 months.
排除标准
- •Recurrent perforation after previous tympanoplasty.
- •Active inflammation of middle ear.
- •Chronic suppurative otitis media epithelial type.
- •Ossicular disruption or fixation diagnosed intraoperatively.
- •Immunocompromised patients including uncontrolled diabetics, chronic liver and kidney diseases.
结局指标
主要结局
Healing rate, or graft take rate.
时间窗: 12 weeks
Closure of the tympanic membrane perforation. An intact tympanic membrane without residual perforation is considered as adequate healing and successful outcome.
次要结局
- Hearing outcomes(12 weeks)
研究者
Hisham Ebada
Assistant Professor
Mansoura University