Hearing Loss, Sensorineural
Conditions
Keywords
cochlear implant, platelet rich fibrin
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.
Interventions
DRUGintracochlear platelet rich fibrin administration
intracochlear platelet rich fibrin administration during routine cochlear implantation surgery
Sponsors
Pamukkale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
open uncontrolled
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Electrode Impedance(Ohm) | 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
| Measure | Time frame | Description |
|---|---|---|
| Electrode thresholds(CL) | 1-6 months | All intra-operative threshold values will be acquired after surgery. They will be repeated in first week, 1, 3 and 6th months |
Countries
Turkey (Türkiye)
Contacts
CONTACTFazil N Ardic, MD
Outcome results
None listed