Condition 1: Tympanic Membrane Perforation. Condition 2: Chronic Otitis Media. Perforation of tympanic membrane Chronic tubotympanic suppurative otitis media
Conditions
Interventions
Intervention 1: Intervention group:Participants undergo tympanoplasty using temporalis fascia with the underlay technique. Platelet-rich fibrin (PRF, used as an adjunct to reinforce the temporalis fas
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Adults aged 18-65 years with a history of Chronic Otitis Media (COM) Patients with at least one risk factor for graft failure Diabetes (controlled or uncontrolled) Long-term smoking history (at least 10 cigarettes per day for more than 5 years) Immunodeficiency (e.g., long-term treatment with steroids or other immunosuppressive drugs) History of failed tympanoplasty surgery (at least one previous unsuccessful tympanoplasty) Tympanic membrane perforation larger than 50% of the membrane surface History of recent active otorrhea (at least once in the past 3 months) with dry ear for at least 3 weeks before surgery Eustachian tube dysfunction
Exclusion criteria
Exclusion criteria: Active ear infection (persistent otorrhea or resistant otorrhea at the time of surgery) Presence of cholesteatoma or internal mastoid complications Congenital anomalies of the ear (e.g., ossicular chain malformations or canal anomalies)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Graft success rate (tympanic membrane graft uptake). Timepoint: The size of the tympanic membrane perforation will be assessed by otoscopy at baseline, and graft uptake will be compared at 1- and 3-month follow-ups after the intervention. Method of measurement: Otosopic examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative infection rate. Timepoint: 1, 3 months after surgery. Method of measurement: Physical examination, otoscopy, and evaluation of clinical signs of infection.;Hearing status. Timepoint: measuring the Air-Bone Gap at baseline and at 1- and 3-month follow-ups after the intervention. Method of measurement: Pure Tone Audiometry. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactBehrouz Barati
Shahid Beheshti University of Medical Sciences
Outcome results
None listed