Intracochlear Platelet-rich Fibrin Application in Cochlear Implantation

Not Applicable

Recruiting

• Conditions: Hearing Loss, Sensorineural
• Interventions: Drug: intracochlear platelet rich fibrin administration

• Registration Number: NCT05215197
• Lead Sponsor: Pamukkale University

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.

Study Timeline

• Study First Submitted: 2022-01-18
• Study First Submitted QC: 2022-01-18
• Study Start: 2022-01-31
• Study First Posted: 2022-01-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-24
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intracochlear prf administration group	intracochlear platelet rich fibrin administration	intracochlear prf administration group

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pamukkale University; 🇹🇷 Denizli, Turkey