Comparison of Results of Myringoplasty Using Biodesign - an Otologic Graft Made From Porcine Small Intestinal Submucosa, Temporalis Fascia, or Tragal Perichondrium - a Retrospective Cohort Analysis (Biodesign)

July 6, 2026 updated by: Wolfson Medical Center

Comparison of Myringoplasty Using Porcine Small Intestinal Submucosa (Biodesign) Versus Autologous Grafts (Perichondrium, Temporalis Fascia, Cartilage, or Fat) for Tympanic Membrane Perforation Closure: A Retrospective Cohort Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Holon, Israel, 5822012
        • Wolfson Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Biodesign
Participants with tympanic membrane perforation who underwent myringoplasty/tympanoplasty using a porcine small intestinal submucosa (Biodesign) graft for perforation repair.
Procedure: tympanoplasty 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.
Other Names:
  • Porcine small intestinal submucosa graft
Autologous grafts
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
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
Other Names:
  • Tragal perichondrium
  • Temporalis fascia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tympanic membrane perforation status (closed vs not closed)
Time Frame: 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.
Three months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in air-bone gap (operated ear)
Time Frame: 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).
Three months after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: Perioperative (day of surgery)
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.
Perioperative (day of surgery)
Adverse events
Time Frame: three months after surgery
Comparing the rate of adverse events like infection and otorrhea
three months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wolfson Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

January 1, 2025

Study Completion (Actual)

January 1, 2025

Study Registration Dates

First Submitted

January 1, 2026

First Submitted That Met QC Criteria

July 6, 2026

First Posted (Actual)

July 13, 2026

Study Record Updates

Last Update Posted (Actual)

July 13, 2026

Last Update Submitted That Met QC Criteria

July 6, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0047-24-WOMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tympanic Membrane Perforation

Clinical Trials on tympanoplasty using Biodesign

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe