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.

Comparison of tympanoplasty outcomes using temporalis fascia graft alone versus temporalis fascia graft combined with PRF in patients referred to Baqiyatallah Hospital.

This study is a randomized single-blind clinical trial (the surgeon is aware of the clinical procedure and PRF preparation, while the patients are blinded to the type of intervention). Patient allocation to groups is performed using block randomization; the first patient is assigned to group one, the second to group two, and so on until the groups are completed

Patients aged 15–65 years undergoing tympanoplasty at Baqiyatallah Hospital will be followed at 1 week, 1 month, and 3 months for assessment of graft healing, hearing, and complications.

Patients aged 15–65 years Inclusion criteria: 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. Exclusion criteria: 1. Lack of consent to participate in the study. 2. Immunodeficiency. 3. Chronic diseases requiring corticosteroid therapy. 4. Nasal polyposis and chronic rhinosinusitis (CRS).

After allocation, patients will undergo tympanoplasty. The surgical procedure is identical in both groups, except that in the intervention group, PRF is used as an adjunct to accelerate the healing process. PRF is obtained from the patient’s own blood and, after processing with a specialized device, is applied to the surgical site. In the control group, the tympanic membrane is repaired using temporalis fascia alone.

TM closure at 3 months; PTA change and ABG reduction at 3 months; complications (infection, graft necrosis, revision); healing time

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.

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.