Intracochlear Platelet-rich Fibrin Application in Cochlear Implantation

Hearing Loss, Sensorineural Clinical Trial

Official title:

Intracochlear Platelet-rich Fibrin Application in Cochlear Implantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05215197
• Other study ID #: 11
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2022
• Est. completion date: December 20, 2024

Study information

• Verified date: September 2023
• Source: Pamukkale University
• Contact: Fazil N Ardic, MD
• Phone: 902582965799
• Email: fnardic[@]pau.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 20, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

Drug:
• intracochlear platelet rich fibrin administration
intracochlear platelet rich fibrin administration during routine cochlear implantation surgery

Locations

Country	Name	City	State
Turkey	Pamukkale University	Denizli

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electrode Impedance(Ohm)	All intra-operative impedance values will be acquired after surgery. They will be repeated in first week, 1, 3 and 6th months	1-6 months
Secondary	Electrode thresholds(CL)	All intra-operative threshold values will be acquired after surgery. They will be repeated in first week, 1, 3 and 6th months	1-6 months