drugset / Trial / NCT07664319

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

NCT07664319

Completed 48 enrolled Ebubekir Toprak
Non-randomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2023-04-01
Primary completion
2023-06-30
Completion
2023-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Platelet Rich Plasma Other / unclassified Other

Indications