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IRCT20240519061839N1 IRCT 2026-04-29 Shahid Beheshti University of Medical Sciences Effect of Using PRF on the Outcome of Tympanic Membrane Repair Surgery Comparison of the effectiveness of tympanoplasty with and without PRF on graft success in patients at high risk of graft failure 2026-02-14 anticipated 60 Complete https://irct.ir/trial/88339 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly assigned to either the tympanoplasty with PRF group or the tympanoplasty without PRF group using block randomization, with blocks generated from a random number table. This method ensures approximately equal numbers of participants in each group, Blinding description: This study is designed as a double-blind trial. Participants are unaware of their group allocation. Outcome assessors, including those evaluating graft uptake, postoperative infection, and audiometric results, are also blinded to group assignment. The surgeon performing the procedure is not blinded due to the nature of the intervention. N/A Condition 1: Tympanic Membrane Perforation. Condition 2: Chronic Otitis Media. Intervention 1: Intervention group:Participants undergo tympanoplasty using temporalis fascia with the underlay technique. Platelet-rich fibrin (PRF, used as an adjunct to reinforce the temporalis fascia graft) is prepared from autologous venous blood by collecting 10 to 15 milliliters in tubes without anticoagulant, followed by centrifugation at 2700 revolutions per minute for 12 minutes. The middle layer containing the PRF clot is extracted, compressed into a membrane, and placed over the temporalis fascia graft after graft positioning. Intervention 2: Control group: Participants undergo standard tympanoplasty using temporalis fascia with the underlay technique without the use of platelet rich fibrin. The temporalis fascia graft is harvested and placed in the tympanic membrane using the conventional underlay method without any adjunctive biological material. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to ethical considerations, patient privacy concerns, and the limited sample size of the study, there is no plan to share deidentified individual participant data. Data will be used solely for the purposes of this study.
public Behrouz Barati
Velenjak, Taleghani hospital, Eerabi Ave., Daneshjou Blvd., Tehran., Iran
Tehran Iran (Islamic Republic of) 1985717413 +98 21 2303 1443 b_barati@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Behrouz Barati
Velenjak, Taleghani hospital, Eerabi Ave., Daneshjou Blvd., Tehran., Iran
Tehran Iran (Islamic Republic of) 1985717413 +98 21 2303 1443 b_barati@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Adults aged 18-65 years with a history of Chronic Otitis Media (COM) Patients with at least one risk factor for graft failure Diabetes (controlled or uncontrolled) Long-term smoking history (at least 10 cigarettes per day for more than 5 years) Immunodeficiency (e.g., long-term treatment with steroids or other immunosuppressive drugs) History of failed tympanoplasty surgery (at least one previous unsuccessful tympanoplasty) Tympanic membrane perforation larger than 50% of the membrane surface History of recent active otorrhea (at least once in the past 3 months) with dry ear for at least 3 weeks before surgery Eustachian tube dysfunction 18 years 65 years Both Active ear infection (persistent otorrhea or resistant otorrhea at the time of surgery) Presence of cholesteatoma or internal mastoid complications Congenital anomalies of the ear (e.g., ossicular chain malformations or canal anomalies) H72 H66.1 Perforation of tympanic membrane Chronic tubotympanic suppurative otitis media Treatment - Surgery Treatment - Surgery Intervention group:Participants undergo tympanoplasty using temporalis fascia with the underlay technique. Platelet-rich fibrin (PRF, used as an adjunct to reinforce the temporalis fascia graft) is prepared from autologous venous blood by collecting 10 to 15 milliliters in tubes without anticoagulant, followed by centrifugation at 2700 revolutions per minute for 12 minutes. The middle layer containing the PRF clot is extracted, compressed into a membrane, and placed over the temporalis fascia graft after graft positioning. Control group: Participants undergo standard tympanoplasty using temporalis fascia with the underlay technique without the use of platelet rich fibrin. The temporalis fascia graft is harvested and placed in the tympanic membrane using the conventional underlay method without any adjunctive biological material. Graft success rate (tympanic membrane graft uptake). Timepoint: The size of the tympanic membrane perforation will be assessed by otoscopy at baseline, and graft uptake will be compared at 1- and 3-month follow-ups after the intervention. Method of measurement: Otosopic examination. Postoperative infection rate. Timepoint: 1, 3 months after surgery. Method of measurement: Physical examination, otoscopy, and evaluation of clinical signs of infection. Hearing status. Timepoint: measuring the Air-Bone Gap at baseline and at 1- and 3-month follow-ups after the intervention. Method of measurement: Pure Tone Audiometry. Shahid Beheshti University of Medical Sciences Approved 2025-12-20 Ethics committee of Shahid Beheshti University of Medical Sciences Arabi Street, Daneshjoo Boulevard, Shahriari Square, Velenjak, Shahid Beheshti University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)