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Platelet-Rich Fibrin in Revision Cartilage Tympanoplasty

RecruitingNAAges 18 Years - 65 YearsAllBakirkoy Dr. Sadi Konuk Research and Training Hos…
NCT07893418 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The aim of this study is to evaluate the success rate of revision surgery using a conchal cartilage graft supported with autologous platelet-rich fibrin (PRF), performed under local anesthesia, in patients who previously underwent cartilage tympanoplasty and later developed a recurrent perforation of the graft requiring revision surgery. In this single-arm prospective study, the perforation will be repaired with a cartilage graft harvested from the concha of the same (previously operated) ear. Both surfaces of the graft will be covered with PRF obtained from the patient's own blood. Patients can be discharged on the same day without systemic antibiotics. The primary outcome is anatomical success, defined as graft integrity and closure of the perforation. Secondary outcomes include hearing results (air-conduction thresholds and air-bone gap), quality of life (COMQ-12), postoperative pai

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📋 Eligibility rules (as published)
Inclusion Criteria: Age between 18 and 65 years Recurrent tympanic membrane perforation after cartilage tympanoplasty performed at our clinic between January 2018 and October 2025 Perforation persisting for at least 3 months Air-bone gap below 30 dB; or air-bone gap above 30 dB with tympanosclerosis noted during the initial surgery, or patient preference for this procedure over open surgery Controlled otorrhea and a dry ear Absence of cholesteatoma and granulation tissue Willingness to participate and signed informed consent Exclusion Criteria: Hematological, autoimmune or malignant disease Active middle ear discharge Uncontrolled infection or presence of granulation tissue Clinically or radiologically confirmed cholesteatoma Any condition preventing venous blood sampling for autologous PRF Need for simultaneous ossicular (hearing) reconstruction Age under 18 or over 65 years
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What it tests

  • PRF-supported conchal cartilage tympanoplasty under local anesthesia
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Where

1 site
University of Health Sciences, Bakırköy Dr. Sadi Konuk Training and Research Hospital
Istanbul, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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