Overview
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 pain (VAS), paracetamol use, change in perforation size, complications and operative time. Patients will be followed for 6 months after surgery. A total of 35 patients are planned to be enrolled.
Description
Background and Study Design This is a single-center, single-arm prospective study conducted at the Department of Otorhinolaryngology, University of Health Sciences Bakırköy Dr. Sadi Konuk Training and Research Hospital, Istanbul, Turkey. To identify eligible participants, patients who underwent cartilage tympanoplasty at our clinic between January 2018 and October 2025 will be screened retrospectively. Patients who developed a graft perforation during follow-up and have an indication for revision surgery will be identified, and those meeting the eligibility criteria will be enrolled prospectively. Graft take rates observed during this screening will be reported only as descriptive data on the clinic's general surgical outcomes, without a direct comparative analysis.
Study Procedure Revision surgery will be performed under local anesthesia. Lidocaine hydrochloride with epinephrine, diluted 1:1, will be infiltrated into the external auditory canal and the conchal region. Perforation size will be measured intraoperatively, and a conchal cartilage graft will be harvested from the ipsilateral (previously operated) ear and shaped accordingly. The graft will be supported on both its medial and lateral surfaces with autologous platelet-rich fibrin (PRF), and the perforation will be repaired. Operative time will be recorded in minutes.
PRF Preparation For the preparation of platelet-rich fibrin, 9 mL of venous blood will be collected from each patient into a red-top BD Vacutainer® Clot Activator tube and centrifuged. After centrifugation, the PRF layer formed in the upper part of the tube will be separated and used in the surgical field. The material is fully autologous and contains no additional biomaterials or chemical agents.
Perforation Measurement Perforation size will be measured in two axes (antero-posterior and supero-inferior) in millimeters using a standardized measuring tool. When needed, the estimated area will be calculated assuming an elliptical shape: Area (mm²) = AP diameter × SI diameter × 0.785. Cases with complete graft integrity will be recorded as 0. Postoperative measurements will be taken after cleaning/aspiration of the external auditory canal.
Postoperative Follow-up Patients may be discharged on the same day with oral paracetamol only, without antibiotics. Ear drops containing ciprofloxacin and dexamethasone (5 drops, three times daily) will be used for 2 weeks, from postoperative week 1 to week 3. The COMQ-12 questionnaire will be administered to all patients before surgery.
Postoperative hour 4: pain assessed with VAS Postoperative week 1: VAS pain score, number of paracetamol tablets used, and clinical evaluation for complications Postoperative week 3: graft status assessed after aspiration of the external auditory canal Postoperative months 3 and 6: pure-tone audiometry Postoperative month 6: COMQ-12 repeated to assess change in quality of life
Data Collection Demographic data (age, sex), indication for revision and clinical characteristics of the perforation, operative time, perioperative and postoperative complications, and postoperative analgesic requirement will be recorded for all patients.
Statistical Analysis Analyses will be performed using IBM SPSS Statistics version 26.0. Normality will be assessed with the Shapiro-Wilk test and histograms. Changes over time in air-conduction thresholds, air-bone gap, COMQ-12 scores, VAS scores and perforation area will be analyzed with repeated measures ANOVA or the Friedman test, as appropriate, followed by Bonferroni-corrected or Wilcoxon signed-rank post-hoc comparisons. Changes in binary outcomes such as graft success will be analyzed with the McNemar test. Correlations will be assessed with Pearson or Spearman analysis, and univariate logistic regression may be used to explore factors associated with graft success. A p value \< 0.05 will be considered statistically significant.
Sample Size Based on the literature, the sample size was calculated with G\*Power (Wilcoxon signed-rank test, one-sample case; effect size d = 0.5, α = 0.05, power = 0.80), yielding a total of 35 patients.
Eligibility
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
