Intracochlear Platelet-rich Fibrin Application in Cochlear Implantation

  • STATUS
    Recruiting
  • days left to enroll
    14
  • participants needed
    10
  • sponsor
    Pamukkale University
Updated on 1 July 2022

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.

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.

Details
Condition Hearing Loss, Sensorineural
Treatment intracochlear platelet rich fibrin administration
Clinical Study IdentifierNCT05215197
SponsorPamukkale University
Last Modified on1 July 2022

Eligibility

Yes No Not Sure

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
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