- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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 (Biodesign)
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Holon, Israel, 5822012
- Wolfson Medical Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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Biodesign
Participants with tympanic membrane perforation who underwent myringoplasty/tympanoplasty using a porcine small intestinal submucosa (Biodesign) graft for perforation repair.
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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.
Andere Namen:
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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.
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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
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Tympanic membrane perforation status (closed vs not closed)
Zeitfenster: Three months after surgery
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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.
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Three months after surgery
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in air-bone gap (operated ear)
Zeitfenster: Three months after surgery
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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).
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Three months after surgery
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Operative time
Zeitfenster: Perioperative (day of surgery)
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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.
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Perioperative (day of surgery)
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Adverse events
Zeitfenster: three months after surgery
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Comparing the rate of adverse events like infection and otorrhea
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three months after surgery
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Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
- 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.
- 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.
- 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.
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 0047-24-WOMC
Plan für individuelle Teilnehmerdaten (IPD)
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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