Status:

NOT_YET_RECRUITING

Comparison of Topical Use of Platelet-rich Plasma Versus Hyaluronic Acid During Endoscopic Fat Graft Myringoplasty: a Randomized Clinical Study

Lead Sponsor:

Assiut University

Conditions:

Chronic Suppurative Otitis Media

Eligibility:

All Genders

14-50 years

Phase:

NA

Brief 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. Ev...

Detailed Description

Tympanic membrane (TM) perforations result in recurrent middle ear infection and hearing loss. Both these hazards can be prevented by the reconstructive surgery of the tympanic membrane. Fat graft my...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

August 30 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 10 2026

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT06505252

Start Date

August 30 2024

End Date

October 10 2026

Last Update

July 17 2024

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