Intracochlear Platelet-rich Fibrin Application in Cochlear Implantation
Overview
- Phase
- Not Applicable
- Intervention
- intracochlear platelet rich fibrin administration
- Conditions
- Hearing Loss, Sensorineural
- Sponsor
- Pamukkale University
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Electrode Impedance(Ohm)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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. Custom Sound EP 5.0 (5.0.4.136) program provided by Cochlear company will be used for these measurements.
Investigators
Fazıl Necdet Ardıç
Head of Department of Otolaryngology
Pamukkale University
Eligibility Criteria
Inclusion Criteria
- •Patients with sensorineural hearing loss
- •Patients who will have cochlear implant surgery with CI422 electrode
Exclusion Criteria
- •Patients with cochlear abnormality
- •Patients with auditory neuropathy
Arms & Interventions
intracochlear prf administration group
intracochlear prf administration group
Intervention: intracochlear platelet rich fibrin administration
Outcomes
Primary Outcomes
Electrode Impedance(Ohm)
Time Frame: 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
Secondary Outcomes
- Electrode thresholds(CL)(1-6 months)