Enhancing the Outcomes of Temporalis Fascia Tympanoplasty Using Autologous Platelet-Rich Plasma and Gel: A Randomized Controlled Trial.

Abstract

Objectives: This study aimed to investigate the impact of platelet-rich plasma (PRP) and platelet-rich gel (PRG) on tympanic membrane closure rates, hearing improvement, and quality of life following tympanoplasty. Methods: Seventy-two patients with chronic tympanic membrane perforations were enrolled in a double-blinded, randomized controlled trial at a single tertiary referral center. All patients underwent tympanoplasty using a temporalis fascia graft and were randomly assigned to one of two groups: one group received standard tympanoplasty alone, while the other received intraoperative application of autologous PRP and PRG, in addition to the standard procedure. Results: The PRP group demonstrated a significantly higher rate of complete tympanic membrane closure compared to the control group (32/36; 88.9% vs. 24/36; 66.7%; p < 0.05). Bone conduction hearing remained unchanged in both groups, while air conduction hearing improved significantly from pre- to post-treatment in each group. However, the difference in air conduction improvement between the PRP group and the control group was not statistically significant (PRP group: Mdn = -8.25; control group: Mdn = -12.20; U = 618; z = -0.54; p = 0.30). Quality of life improved in both the PRP and control groups; however, the difference between the groups was not statistically significant (PRP group: 10.44 ± 10.46; control group: 10.47 ± 8.22; 95% CI [-4.45; 4.40]; t(66) = -0.01; p = 0.16). Conclusions: Our findings suggest that intraoperative application of autologous PRP and PRG may improve tympanoplasty outcomes, particularly in cases with lower expected success rates or when performing minimally invasive transcanal procedures under local anesthesia. However, variability in PRP preparation, application methods, and graft materials across studies limits direct comparisons. Standardized protocols and further controlled studies are necessary to clarify PRP's clinical value in tympanoplasty.