Pig-Derived patch could simplify eardrum surgery
NCT ID NCT07698171
First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time
Summary
This study looks at whether a commercially available graft made from pig intestinal tissue (Biodesign) works as well as a patient's own tissue for closing a hole in the eardrum. Researchers will review medical records of 60 people who had eardrum repair surgery to compare closure rates, hearing improvement, and operating time between the two graft types. The goal is to see if the ready-made graft can be a safe and effective alternative that may shorten surgery time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Porcine small intestinal submucosa graft (Biodesign)
- What this could lead to
- If Biodesign works as well as a patient's own tissue, it could offer a simpler, faster surgical option for repairing eardrum holes without needing to harvest the patient's own tissue.
- What could go wrong
- This is a small, retrospective study, so results may not apply to everyone. The porcine graft might not close the hole as effectively or could cause unexpected reactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
60 people
The number who actually took part.
- Started
-
Jan 2020
- Finished
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Jan 2025
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Wolfson Medical Center
Holon, 5822012, Israel
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Other studies related to the condition(s) this trial covers.
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