Intracochlear Platelet-rich Fibrin Application in Cochlear Implantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Electrode Impedance(Ohm)
研究概览
简要总结
Fibrosis due to surgical trauma is a common problem with cochlear implants. Fibrosis limits the effectiveness of implant and increases the power consumption. Our aim in this study is to benefit from the anti-inflammatory effects of autologous platelet-rich fibrin to reducing the fibrotic cascade.
详细描述
The most common problem with cochlear implants is that their effectiveness decreases over time and they are not functional enough mainly due to fibrosis.
Our aim in this study is to benefit from the anti-inflammatory effects of autologous platelet-rich fibrin to reducing the fibrotic cascade.
Cochlear implant application will be performed under general anesthesia. After the postauricular incision and mastoidectomy, posterior tympanotomy will find the middle ear and from there the round window, and platelet fibrin prepared with the i-prf technique will be locally applied to the round window during the operation, and then implantation will be performed.
The points where the electrode enters the cochlea will be covered with fascia.
Intraoperative NRT and impedances will be measured on all electrodes in all patients, and NRT and impedance measurements will be repeated in the 1st week, 1st month, 3rd and 6th months postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with sensorineural hearing loss
- •Patients who will have cochlear implant surgery with CI422 electrode
排除标准
- •Patients with cochlear abnormality
- •Patients with auditory neuropathy
研究组 & 干预措施
intracochlear prf administration group
intracochlear prf administration group
干预措施: intracochlear platelet rich fibrin administration (Drug)
结局指标
主要结局
Electrode Impedance(Ohm)
时间窗: 1-6 months
All intra-operative impedance values will be acquired after surgery. They will be repeated in first week, 1, 3 and 6th months
次要结局
- Electrode thresholds(CL)(1-6 months)
研究者
Fazıl Necdet Ardıç
Head of Department of Otolaryngology
Pamukkale University