An observational study in Tympanic Membrane Perforation, Tympanoplasty and Myringoplasty, sponsored by Wolfson Medical Center. Completed at 1 site in Israel. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Wolfson Medical Center · Observational
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.
45 studies on the registry are indexed under Tympanic Membrane Perforation; 10 are open to participants now.
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Participants were selected from the otology practice of our department and included people diagnosed with a tympanic membrane perforation who underwent myringoplasty/tympanoplasty performed by our surgical team between 2020 and 2024. Cases were be identified from operative records and medical charts, with baseline and follow-up information obtained from routine clinic documentation and audiology testing performed as part of usual care
Exclusion Criteria:
Participants with tympanic membrane perforation who underwent myringoplasty/tympanoplasty using a porcine small intestinal submucosa (Biodesign) graft for perforation repair.
Procedure: tympanoplasty using Biodesign
Participants with tympanic membrane perforation who underwent myringoplasty/tympanoplasty using the participant's own tissue for perforation repair (tragal perichondrium, temporalis fascia, cartilage, or fat), as documented in the operative report.
Procedure: tympanoplasty using autologous tissue graft
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.
Also known as: Porcine small intestinal submucosa 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
Also known as: Tragal perichondrium, Temporalis fascia
Tympanic membrane perforation status (closed vs not closed)
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.
Time frame: Three months after surgery
Change in air-bone gap (operated ear)
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).
Time frame: Three months after surgery
Operative time
Operative time (in minutes) will be obtained from the operative record and compared between procedures performed using a porcine small intestinal submucosa graft (Biodesign) and procedures performed using autologous tissue grafts.
Time frame: Perioperative (day of surgery)
Adverse events
Comparing the rate of adverse events like infection and otorrhea
Time frame: three months after surgery
Plan to share: No
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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