Myringoplasty, Tympanic Membrane Perforation, Tympanoplasty
Conditions
Keywords
Biodesign, Tragal perichondrium, Autologous tissue graft
Brief summary
The goal of this observational, retrospective study is to learn whether a ready-made graft patch (Biodesign, made from porcine small intestinal submucosa) works as well as a participant's own tissue graft (such as tragal perichondrium or temporalis fascia) to close a hole in the eardrum (tympanic membrane perforation). The main questions this study aims to answer are: Does the eardrum hole close after surgery, and is the closure rate similar between Biodesign and autologous tissue grafts? Do participants have similar hearing improvement after surgery (measured by the air-bone gap, a common hearing test measure)? Is the operating time different between the graft types? Are there differences in complications or adverse reactions? Study hypothesis: Biodesign will have a similar eardrum closure rate compared with autologous tissue grafts, with similar hearing improvement and low complication rates, and may be associated with a shorter operating time. How the study will work: Investigators will review medical records of participants who had myringoplasty/tympanoplasty for eardrum perforation in the department between 2020 and 2024. Data already recorded as part of usual care will be collected, including: pre-surgery eardrum findings (size and location of the perforation) and hearing tests; operative details (technique and operating time); and follow-up at about 3 months, including an ear exam to confirm closure and check for adverse reactions, plus a hearing test. Participants will be excluded if they have other ear conditions (such as cholesteatoma, otosclerosis, or tympanosclerosis), if the eardrum was described as flaccid, or if follow-up or post-operative hearing data are missing.
Interventions
PROCEDUREtympanoplasty using Biodesign
Porcine small intestinal submucosa graft (Biodesign) A commercially available extracellular matrix sheet made from porcine small intestinal submucosa (SIS), supplied as a sterile, freeze-dried soft-tissue graft. The surgeon uses the SIS sheet as the tympanic membrane graft to seal the perforation during myringoplasty.
PROCEDUREtympanoplasty using autologous tissue graft
A graft made from the participant's own tissue harvested at surgery and used to repair the tympanic membrane perforation. In this dataset, autologous grafts are primarily tragal perichondrium and temporalis fascia. This approach requires a donor-site harvest and the graft is shaped and placed to cover the perforation
Sponsors
Wolfson Medical Center
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with tympanic membrane perforation and undergoing myringoplasty by our department between 2020 and 2024
Exclusion criteria
* Patients with cholesteatoma, otosclerosis, tympanosclerosis. * Operations that describe a flaccid tympanic membrane and those that included more than one graft material. * No follow up data or no post-operative audiometry.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tympanic membrane perforation status (closed vs not closed) | Three months after surgery | Tympanic membrane status will be determined from postoperative ear examination (otoscopy or microscopy) documented in the medical record. The measure is the proportion of participants with an intact tympanic membrane (no residual perforation) at the follow-up visit closest to 3 months after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in air-bone gap (operated ear) | Three months after surgery | Air-bone gap will be calculated from standard pure-tone audiometry for the operated ear before surgery and at the follow-up visit closest to 3 months after surgery. The outcome is the change in air-bone gap from baseline to follow-up (in decibels). |
Countries
Israel
Outcome results
None listed