]>
IRCT20240108060650N2 IRCT 2025-09-05 Bagheiat-allah University of Medical Sciences Evaluation of the Effect of Platelet-rich Fibrin on the Outcomes of Tympanoplasty Using Temporalis Fascia Graft: A Randomized Clinical Trial Randomized clinical trial; patients with tympanic membrane perforation, effect of Platelet-Rich Fibrin versus no PRF on graft uptake and hearing improvement after tympanoplasty using temporalis fascia graft. 2025-09-23 anticipated 60 Complete https://irct.ir/trial/85631 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block randomization was used, with the individual patient as the randomization unit. The random sequence was generated using statistical software (e.g., Random Allocation Software) with variable block sizes of 4 and 6 to minimize predictability. The sequence list was prepared by an independent researcher and placed in opaque, sealed, and sequentially numbered envelopes. Upon patient enrollment, the corresponding envelope was opened and the patient was allocated to the respective group. This ensured proper allocation concealment, with both investigators and patients blinded to the assignment until the moment of allocation, Blinding description: This trial is conducted as a single-blind study. In this design, patients are blinded to the type of intervention (use or non-use of PRF). Although the surgeon is necessarily aware of group allocation due to the nature of the procedure, outcome assessments (tympanic membrane examination and audiometric testing) are performed by an independent evaluator blinded to the intervention. In addition, data analysis is conducted by a statistician who remains unaware of the group assignments. Thus, patients, the outcome assessor, and the data analyst are blinded, while only the surgeon is aware of the intervention. 3 tympanic membrane perforation. Intervention 1: Intervention group: In the intervention group, following tympanoplasty with temporalis fascia graft, PRF is used as an adjunct to accelerate the healing process. PRF is obtained from the patient’s own blood and, after processing using a specialized device, is applied to the surgical site. Intervention 2: Control group: In the control group, the tympanic membrane is repaired using temporalis fascia alone. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No additional information available
public Keyarmin Ghavam
Eisargaran Shomali, Farhang 3rd, No. 14
Tehran Iran (Islamic Republic of) 1981776397 +98 21 2213 4625 kagh7495@gmail.com Bagheiat-allah University of Medical Sciences scientific Keyarmin Ghavam
Eisargaran Shomali, Farhang 3rd, No. 14
Tehran Iran (Islamic Republic of) 1981776397 +98 21 2213 4625 kagh7495@gmail.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) 1. Central tympanic membrane perforation larger than 25%. 2. No middle ear involvement on temporal bone CT. 3. No scutum erosion on CT scan. 4. Air–bone gap on audiogram less than 40 dB. 5. No active fungal otorrhea. 15 years 65 years Both 1. Lack of consent to participate in the study 2. Immunodeficiency 3. Chronic diseases requiring corticosteroid therapy 4. Nasal polyposis and chronic rhinosinusitis (CRS) H72.0 Central perforation of tympanic membrane Treatment - Surgery Treatment - Surgery Intervention group: In the intervention group, following tympanoplasty with temporalis fascia graft, PRF is used as an adjunct to accelerate the healing process. PRF is obtained from the patient’s own blood and, after processing using a specialized device, is applied to the surgical site. Control group: In the control group, the tympanic membrane is repaired using temporalis fascia alone. Hearing threshold. Timepoint: At 1 month and 3 months follow-up. Method of measurement: audiometric testing. Bagheiat-allah University of Medical Sciences Approved 2025-08-05 Research Ethics Committees of Baqiyatallah of medical sciences Molla Sadra Street, at the intersection with Sheikh Bahayi tehran Tehran Iran (Islamic Republic of)