Intracochlear Platelet-rich Fibrin Application in Cochlear Implantation
NCT ID: NCT05215197
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2022-01-31
2025-12-20
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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intracochlear prf administration group
intracochlear prf administration group
intracochlear platelet rich fibrin administration
intracochlear platelet rich fibrin administration during routine cochlear implantation surgery
Interventions
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intracochlear platelet rich fibrin administration
intracochlear platelet rich fibrin administration during routine cochlear implantation surgery
Eligibility Criteria
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Inclusion Criteria
* Patients who will have cochlear implant surgery with CI422 electrode
Exclusion Criteria
* Patients with auditory neuropathy
ALL
No
Sponsors
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Pamukkale University
OTHER
Responsible Party
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Fazıl Necdet Ardıç
Head of Department of Otolaryngology
Locations
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Pamukkale University
Denizli, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Fazil N Ardic, MD
Role: primary
Other Identifiers
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11
Identifier Type: -
Identifier Source: org_study_id