CompletedNot Applicable

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

Turkey (Türkiye)48 participantsStarted 2023-04-01

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Central tympanic membrane perforation present for at least 6 months No active discharge in the preceding 3 months Able to undergo and cooperate with preoperative pure-tone audiometry Available for follow-up Exclusion Criteria: * Planned concurrent mastoidectomy Cholesteatoma (on imaging or intraoperative inspection) History of ventilation tube insertion on the affected side Revision surgery Uncontrolled hypertension or diabetes mellitus Coagulation disorder or antiplatelet/anticoagulant therapy Anaemia (Hgb \<12 g/dL) or thrombocytopenia (platelets \<150,000/µL) Active malignancy Serious psychiatric illness Occupation involving high pressure changes (e.g., diver, pilot) Rheumatic disease history

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Graft integrity (intact tympanic membrane)

Timeframe: 2 months postoperatively

Trial details

NCT IDNCT07664319

SponsorEbubekir Toprak

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-30

View on ClinicalTrials.gov More Chronic Otitis Media Tympanic Membrane Perforation trials