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

NCT07664319 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-06-24

No results posted yet for this study

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.

Conditions

  • Chronic Otitis Media Tympanic Membrane Perforation

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

Sponsors & Collaborators

  • Ebubekir Toprak

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07664319 on ClinicalTrials.gov