Skip to main content
OpenTrials
Completed

NCT Number: NCT07698171

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Wolfson Medical Center

Holon, 5822012, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tympanoplasty using Biodesign

Procedure

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

tympanoplasty using autologous tissue graft

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

Other outcomes

  1. 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.

  2. Adverse events

    Time frame: three months after surgery

    Comparing the rate of adverse events like infection and otorrhea

Sponsors and collaborators

Lead sponsor

Wolfson Medical Center

Other Gov

Registry information

Official study title

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

Acronym: Biodesign

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.