Platelet-Rich Fibrin–Supported Conchal Cartilage Graft for Revision Tympanoplasty
Official title: An Innovative Approach In Revision Cartilage Tympanoplasty: A Prospective Study With Platelet-Rich Fibrin (PRF) Support
Run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital · NCT07893418 · Data updated 2026-11-12
This study tests whether using a patient’s own conchal cartilage graft with platelet-rich fibrin can repair a recurrent perforation after prior cartilage tympanoplasty, done under local anesthesia.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 35 (estimated) |
| Sponsor | Bakirkoy Dr. Sadi Konuk Research and Training Hospital Government |
| Locations | 1 site (Istanbul, Bakırköy) |
| Status | Recruiting |
| Started | February 15, 2026 |
| Main results expected | February 1, 2027 |
| Study ends | February 1, 2027 |
| Registry record updated | October 26, 2026 |
| Trial ID | NCT07893418 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–65 years with recurrent perforation after prior cartilage tympanoplasty, dry ear, no cholesteatoma or granulation tissue, and a preference for this approach.
✕Probably not a fit
Patients with active infection, cholesteatoma, or factors preventing graft take may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-arm prospective study conducted at a Turkish otolaryngology center. Adults with recurrent tympanic membrane perforation after previous cartilage tympanoplasty will receive a revision graft harvested from the same ear, supported on both sides with autologous platelet-rich fibrin and repaired under local anesthesia. The primary outcome is anatomical success (graft integrity and perforation closure); secondary outcomes include hearing changes, quality of life, pain, analgesic use, perforation size change, complications, and operative time. Eligible participants are identified from patients treated between 2018 and 2025, with exclusion of active infection, cholesteatoma, and other contraindications. The study reports descriptive graft take rates and does not include a direct comparative analysis.
Why it matters
Potential benefit: If successful, patients may experience durable perforation closure with potentially improved hearing and quality of life after revision tympanoplasty.
How similar studies have gone: Prior work in autologous PRF and cartilage grafting in otologic surgery suggests potential benefit, but this specific revision tympanoplasty approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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University of Health Sciences, Bakırköy Dr. Sadi Konuk Training and Research Hospital
Istanbul, Bakırköy, Turkey (Türkiye) Recruiting
Study contacts
- Principal investigator: İbrahim Ömer Gürlek, MD — University of Health Sciences, Bakırköy Dr. Sadi Konuk Training and Research Hospital, Department of Otorhinolaryngology
- Study coordinator: İbrahim Ömer Gürlek, MD
- Email: drogurlek@gmail.com
- Phone: +905058628939
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.