Intracochlear Platelet-rich Fibrin Application in Cochlear Implantation

Pamukkale University

Status: Enrolling

Conditions: Hearing Loss, Sensorineural

Treatments: Drug: intracochlear platelet rich fibrin administration

Study type: Interventional

Funder types: Other

Identifiers

NCT05215197

11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

intracochlear prf administration group

Experimental group

Description:

intracochlear prf administration group

Treatment:

Drug: intracochlear platelet rich fibrin administration