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Document Type

Original Study

Keywords

Tympanoplasty, Myringoplasty, Platelet-rich plasma, Tympanic membrane perforation, Chronic otitis media, Hearing outcomes, Temporalis fascia, Randomized controlled trial

Abstract

Objective: To evaluate hearing outcomes and functional success following tympanoplasty with and without platelet-rich plasma (PRP) in chronic tympanic membrane (TM) perforation cases. Methods: Thirty participants were randomized equally into two groups: one underwent tympanoplasty with PRP (n=15), and the other without PRP (control group, n=15). This single-center prospective randomized controlled trial was conducted at Capital University Hospital (Badr Hospital) from April 2024 to December 2024, and was registered in the Pan African Clinical Trials Registry (PACTR) (registration number: PACTR202609616749959). Preoperative and postoperative air-bone gap (ABG) values were evaluated to assess hearing improvement. Functional success was identified as an ABG gain >10 dB. disc The hearing results were also compared with findings from previously published studies. Results: Postoperative average ABG gains were higher in the PRP group than the control group. At 3 months, the PRP group achieved a significantly lower mean ABG of 13.87 ± 9.70 dB compared to 20.67 ± 5.22 dB in the control group (p = 0.026). Functional success was achieved in 11 of 15 cases (73.3%) in the PRP group and 9 of 15 cases (60.0%) in the control group. The difference in success rates among the groups did not reach statistical significance (p = 0.699, Fisher's exact test). Complete TM closure was observed in 93.3% of the PRP group versus 80% in the control group at 3 months (p = 0.598). These outcomes were consistent with prior studies, which demonstrated functional success rates of 65.6–90% in PRP-treated patients and 40.6–77.1% in controls. Conclusion: PRP-assisted tympanoplasty demonstrated a trend toward improved graft uptake and hearing outcomes. However, most differences did not reach statistical significance, which may be attributable to the small sample size and limited statistical power. The small sample size might have decreased statistical power to identify significant between-group differences, and the 3-month follow-up was inadequate to assess long-term graft stability. Larger randomized trials with longer follow-up are required before routine use can be recommended.

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