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NCT Number: NCT05215197

Intracochlear Platelet-rich Fibrin Application in Cochlear Implantation

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.

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Key information

Conditions

Hearing Loss, Sensorineural Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale University

Denizli, 20070, Turkey (Türkiye)

Location status: Recruiting

Location contact

Fazil N Ardic, MD

CONTACT

[email protected]

+902582965799

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intracochlear platelet rich fibrin administration

Drug

intracochlear platelet rich fibrin administration during routine cochlear implantation surgery

Primary outcomes

  1. Electrode Impedance(Ohm)

    Time frame: 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 outcomes

  1. Electrode thresholds(CL)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Fazil N Ardic, MD

CONTACT

[email protected]

902582965799

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Jan 31, 2022
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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