Intracochlear Platelet-rich Fibrin Application in Cochlear Implantation
ConditionHearing Loss, Sensorineural
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorPamukkale University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with sensorineural hearing loss
Patients who will have cochlear implant surgery with CI422 electrode
Disqualifiers
Patients with cochlear abnormality
Patients with auditory neuropathy
Trial design
Design model
Single group
Treatments tested in this trial
intracochlear platelet rich fibrin administration
Drugintracochlear platelet rich fibrin administration during routine cochlear implantation surgery
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: intracochlear prf administration groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
1-6 monthsSecondary outcomes
1
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
Time frame
1-6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov