Chronic otitis media. Perforation of tympanic membrane
Conditions
Interventions
Intervention 1: Control Group:Two-layer Tympanoplasty Technique: Underlay tympanoplasty using a composite tragal island cartilage-perichondrium graft. Following freshening of the perforation margins,
Sponsors
Shiraz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients must be between 18 and 65 years of age. Patients must be candidates for tympanoplasty surgery. The ear must be dry upon pre-operative examination. The tympanic membrane perforation must be of moderate size. The edges of the perforation must be acceptable and well-defined intraoperatively.
Exclusion criteria
Exclusion criteria: Presence of purulent discharge during intraoperative examination under anesthesia. Requirement for mastoidectomy due to mastoid pathology (e.g., cholesteatoma, advanced ear infection, granulation tissue, or extensive tympanosclerosis plaque). Individuals with diabetes or immune deficiency. History of smoking or tobacco use. Unstable ossicular chain status. Extensive or marginal tympanic membrane perforations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hearing improvement: measured by audiometry 2 months after surgery. This is the main quantitative measure used to assess the effect of the intervention (two-layer vs. three-layer graft).Graft success / tympanic membrane repair – evaluated by microscopic examination at 2 and 6 months after surgery. This is a separate outcome measuring anatomical success of the graft. Timepoint: 6 months after surgery. Method of measurement: Hearing improvement is measured by performing pure tone audiometry in a soundproof chamber and according to standard protocols. | — |
Secondary
| Measure | Time frame |
|---|---|
| Anatomical graft success, assessed via microscopic examination for graft integrity, absence of perforation, granulation tissue, discharge, or other local complications. Timepoint: 2 months and 6 months after surgery. Method of measurement: Pure-tone audiometry was performed in a soundproof booth according to standard protocols. Air conduction thresholds at 0.5, 1, 2, and 4 kHz were measured, and the average air-bone gap was calculated.;. Timepoint: . Method of measurement: . | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNazila Shiravani
Shiraz University of Medical Sciences
Outcome results
None listed