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

NCT07698171 | Completed

• 1 other identifier: 0047-24-WOMC
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Tympanic Membrane Perforation; Tympanoplasty; Myringoplasty

Keywords

Biodesign; Tragal perichondrium; Autologous tissue graft

Outcome Measures

Primary Outcomes (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.

  Three months after surgery

Secondary Outcomes (1)

• Change in air-bone gap (operated ear)

  Three months after surgery

Other Outcomes (2)

• Operative time

  Perioperative (day of surgery)

• Adverse events

  three months after surgery

Study Arms (2)

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

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

Interventions

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.

Also known as: Porcine small intestinal submucosa graft

Biodesign

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

Also known as: Tragal perichondrium, Temporalis fascia

Autologous grafts

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wolfson Medical Center: lead

Study Sites (1)

Wolfson Medical Center

Holon, 5822012, Israel

Location

Related Publications (5)

• 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.

  PMID: 29738388 RESULT

• 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.

  PMID: 25956867 RESULT

• 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.

  PMID: 21217958 RESULT

• 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.

  PMID: 34874794 RESULT

• 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.

  PMID: 22754796 RESULT

MeSH Terms

Conditions

Tympanic Membrane Perforation

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2026
• First Posted: July 13, 2026
• Study Start: January 1, 2020
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)