Pig-Derived patch could simplify eardrum surgery

NCT ID NCT07698171

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Jan 2025

Lead sponsor

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

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

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.

Tympanic Membrane Perforation

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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