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Tympanic Membrane PerforationBiodesignNCT07698171

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

An observational study of Tympanic Membrane Perforation and Tympanoplasty, run by Wolfson Medical Center at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Any age
What is being tested?
tympanoplasty using Biodesign and tympanoplasty using autologous tissue graft
Type of treatment
Surgery or procedure
How many people
60 participants
Where
1 siteIsrael
Study dates
1 Jan 2020to 1 Jan 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • Patients diagnosed with tympanic membrane perforation and undergoing myringoplasty by our department between 2020 and 2024

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Wolfson Medical Center

    Holon, 5822012

Other trials in Israel

About this study

Official 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

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?

Read more

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.

Being tested
tympanoplasty using Biodesign, tympanoplasty using autologous tissue graft
Keywords
Biodesign, Tragal perichondrium, Autologous tissue graft
Medical subject headings
Tympanic Membrane Perforation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tympanoplasty using BiodesignProcedure or surgery

    Also called Porcine small intestinal submucosa 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.

  • tympanoplasty using autologous tissue graftProcedure or surgery

    Also called Tragal perichondrium, Temporalis fascia

    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

Study groups in NCT07698171
Study groupRoleWhat they receive
BiodesignParticipants with tympanic membrane perforation who underwent myringoplasty/tympanoplasty using a porcine small intestinal submucosa (Biodesign) graft for perforation repair.
Receives: Procedure: tympanoplasty using Biodesign
Autologous graftsParticipants 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.
Receives: Procedure: tympanoplasty using autologous tissue graft

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Three months after surgery

Secondary outcomes (1)

  1. 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).

    Measured: Three months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2026
  2. Study start1 Jan 2020
  3. Primary completion1 Jan 2025
  4. Study completion1 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07698171
Sponsor's protocol ID
0047-24-WOMC
Acronym
Biodesign
Status last verified
Jul 2026
First submitted
1 Jan 2026
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yawn RJ, Dedmon MM, O'Connell BP, Virgin FW, Rivas A. Tympanic Membrane Perforation Repair Using Porcine Small Intestinal Submucosal Grafting. Otol Neurotol. 2018 Jun;39(5):e332-e335. doi: 10.1097/MAO.0000000000001792.

    PubMed 29738388

  • D'Eredita R. Porcine small intestinal submucosa (SIS) myringoplasty in children: A randomized controlled study. Int J Pediatr Otorhinolaryngol. 2015 Jul;79(7):1085-9. doi: 10.1016/j.ijporl.2015.04.037. Epub 2015 Apr 30.

    PubMed 25956867

  • Cho YS, Choi SH, Park KH, Park HJ, Kim JW, Moon IJ, Rhee CS, Kim KS, Sun DI, Lee SH, Koo JW, Koh YW, Lee KH, Lee SW, Oh KW, Pyo EY, Lee A, Kim YT, Lee CH. Prevalence of otolaryngologic diseases in South Korea: data from the Korea national health and nutrition examination survey 2008. Clin Exp Otorhinolaryngol. 2010 Dec;3(4):183-93. doi: 10.3342/ceo.2010.3.4.183. Epub 2010 Dec 22.

    PubMed 21217958

  • Kim AS, Betz JF, Reed NS, Ward BK, Nieman CL. Prevalence of Tympanic Membrane Perforations Among Adolescents, Adults, and Older Adults in the United States. Otolaryngol Head Neck Surg. 2022 Aug;167(2):356-358. doi: 10.1177/01945998211062153. Epub 2021 Dec 7.

    PubMed 34874794

  • Pannu KK, Chadha S, Kumar D, Preeti. Evaluation of hearing loss in tympanic membrane perforation. Indian J Otolaryngol Head Neck Surg. 2011 Jul;63(3):208-13. doi: 10.1007/s12070-011-0129-6. Epub 2011 Feb 23.

    PubMed 22754796

Questions about this trial

What is this clinical trial studying?

An observational study of Tympanic Membrane Perforation and Tympanoplasty, run by Wolfson Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tympanic membrane perforation status (closed vs not closed) (time frame: Three months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07698171, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.

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