NCT05215197

Intracochlear Platelet-rich Fibrin Application in Cochlear Implantation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Pamukkale University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Hearing Loss, Sensorineural

Interventions

Type	Name	Description
DRUG	intracochlear platelet rich fibrin administration	intracochlear platelet rich fibrin administration during routine cochlear implantation surgery

Timeline

• Start date: 2022-01-31
• Primary completion: 2025-12-01
• Completion: 2025-12-20
• First posted: 2022-01-31
• Last updated: 2024-12-27

Locations

1 site across 1 country: Turkey (Türkiye)