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COMPLETED
NCT07664319
NA

Effect of Platelet-Rich Plasma on Eardrum Healing and Hearing After Tympanoplasty in Adults

Sponsor: Ebubekir Toprak

View on ClinicalTrials.gov

Summary

This single-center controlled trial evaluated whether intraoperative application of autologous platelet-rich plasma (PRP)-impregnated absorbable gelatin sponge improves graft take rates and audiological outcomes in adults undergoing tympanoplasty for chronic otitis media with tympanic membrane perforation. Forty-eight patients were allocated by systematic alternation to a PRP group (PRP-impregnated Spongostan placed in the middle ear and lateral to the graft) or a control group (dry Spongostan). The primary outcome was graft integrity at two months; the secondary outcome was improvement in the air-bone gap.

Official title: Intraoperative Use of Platelet-Rich Plasma in Tympanoplasty: Effects on Graft Success and Audiological Outcomes - A Prospective Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2023-04-01

Completion Date

2023-08-31

Last Updated

2026-06-24

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

Autologous platelet-rich plasma (PRP)-impregnated Spongostan

PRP-impregnated absorbable gelatin sponge placed in the middle ear and lateral to the graft during tympanoplasty

OTHER

Dry Spongostan (absorbable gelatin sponge)

Dry absorbable gelatin sponge placed in the same positions without PRP

Locations (1)

Sbü Sisli Hamidiye Etfal Eah

Istanbul, Sisli, Turkey (Türkiye)