Intracochlear Platelet-rich Fibrin Application in Cochlear Implantation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intracochlear Platelet-rich Fibrin Application in Cochlear Implantation

Conditions
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Hearing Loss, Sensorineural

Intervention / Treatment
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* Drug: intracochlear platelet rich fibrin administration


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: open uncontrolled
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intracochlear prf administration group<br>intracochlear prf administration group | Drug: intracochlear platelet rich fibrin administration<br>* intracochlear platelet rich fibrin administration during routine cochlear implantation surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrode Impedance(Ohm) | All intra-operative impedance values will be acquired after surgery. They will be repeated in first week, 1, 3 and 6th months | 1-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrode thresholds(CL) | All intra-operative threshold values will be acquired after surgery. They will be repeated in first week, 1, 3 and 6th months | 1-6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cochlear implant, platelet rich fibrin