Comparison of Topical Use of Platelet-rich Plasma Versus Hyaluronic Acid During Endoscopic Fat Gr… (NCT06505252) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparison of Topical Use of Platelet-rich Plasma Versus Hyaluronic Acid During Endoscopic Fat Graft Myringoplasty: a Randomized Clinical Study
60 participantsStarted 2024-08-30
Plain-language summary
This study aimed to compare the effect of adding HA versus PRP to endoscopic FGM in cases of small or medium-sized central TM perforation in the form of:
1. Evaluation of the graft uptake rate.
2. Evaluation and comparing audiological outcomes.
3. Finding out intraoperative and postoperative morbidity.
Who can participate
Age range
14 Years – 50 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:
* Patients with central small or median sized dry perforation
* Aged between 14 and 50 years
* In cases of CSOM the perforation must be dry with no otorrhea with healthy middle ear mucosa for at least three month without medications
* Conductive gap on audiometry not more than 40 dB.
Exclusion Criteria:
* Discharging CSOM .
* Concurrent URTI .
* CSOM with dry marginal perforation
* Patients who didn't come for follow up.
* Age less than 14 or more than 50.
* Unsafe CSOM with cholesteatoma, apparent retraction pockets, granulations, or extensive myringosclerosis reaching the edges of the perforation. Patients
* Patients who are suspected of having Eustachian tube dysfunction.
* Suspected ossicular pathology in safe CSOM if the ABG \> 40dB.
* Patients with history of Previous ear surgery.
* Patients unfit for surgery or having chronic medical illness.
* Narrow external auditory canal.
* Patients who refused to enrolled in our study
* Patients with sensorineural hearing loss or only functioning ear.
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
1
graft taking
Timeframe: 3 months
Trial details
NCT IDNCT06505252
SponsorAssiut University
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2026-07-09
Contact for this trial
Ahmed Gamal Ahmed Gamal Abdel-Hameed, Assistant lecture