A Prospective Comparative Study of Dry vs Wet Temporalis Fascia Graft in Tympanoplasty
This study was conducted to compare two methods of using temporalis fascia graft in tympanoplasty, namely wet temporalis fascia graft and dry temporalis fascia graft. Tympanoplasty is an ear surgery performed to repair a hole in the ear drum and to improve hearing in patients with chronic otitis media. Temporalis fascia is a thin layer of tissue taken from the area over the temple muscle and is commonly used as graft material for repair of the ear drum.
The study included adult patients aged 18 to 60 years who had chronic otitis media with inactive mucosal disease, a large central perforation of the ear drum, and conductive hearing loss confirmed on pure-tone audiometry. Patients were assigned to one of two treatment groups. One group underwent tympanoplasty using a wet temporalis fascia graft, while the other group underwent tympanoplasty using a dry temporalis fascia graft.
The main purpose of the study was to assess whether one graft preparation technique gave better surgical and hearing outcomes than the other. The outcomes were assessed three months after surgery. Hearing improvement was measured by comparing the air-bone gap before and after surgery on pure-tone audiometry. Graft success was assessed by otoscopic examination to determine whether the graft had healed properly, remained in correct position, and closed the ear drum perforation. Complete air-bone gap closure was also assessed as an additional hearing outcome.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Shaikh Zayed Medical college/hospital, Lahore
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Patients aged 18 to 60 years.
- Patients of either gender.
- Patients diagnosed with chronic otitis media.
- Patients with inactive mucosal disease, with no active ear discharge.
- Patients with a large central perforation of the tympanic membrane.
- Tympanic membrane perforation persisting for at least 6 weeks.
- Patients with pure conductive hearing loss confirmed on pure-tone audiometry.
Exclusion Criteria:
- Patients with active otitis media, acute infection, or active ear discharge.
- Patients with tympanosclerosis or ossicular necrosis affecting ossicular chain mobility.
- Patients with a history of previous ear surgery that could affect tympanoplasty outcomes, such as ossiculoplasty or mastoidectomy, except prior myringotomy.
- Patients with sensorineural hearing loss or mixed hearing loss.
- Patients with conditions impairing wound healing or postoperative care compliance, including uncontrolled diabetes mellitus or immunodeficiency disorders.
- Patients with confirmed Eustachian tube dysfunction.
- Patients with active infection in the throat, nose, paranasal sinuses, or oral cavity.
- Patients with bleeding disorders.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Group Wet Temporalis Fascia Graft
Participants in this group underwent tympanoplasty using the wet temporalis fascia graft technique for repair of tympanic membrane perforation.
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Tympanoplasty was performed using a wet temporalis fascia graft to repair the tympanic membrane perforation.
Postoperative assessment was performed at 3 months using otoscopic examination and pure-tone audiometry
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Aktiver Komparator: Group Dry Temporalis Fascia Graft
Participants in this group underwent tympanoplasty using the dry temporalis fascia graft technique for repair of tympanic membrane perforation.
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Tympanoplasty was performed using a dry temporalis fascia graft to repair the tympanic membrane perforation.
Postoperative assessment was performed at 3 months using otoscopic examination and pure-tone audiometry.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Mean hearing gain after tympanoplasty
Zeitfenster: 3 months after surgery
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Mean hearing gain was measured by comparing the preoperative and postoperative air-bone gap on pure-tone audiometry.
The air-bone gap was assessed at 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz.
Mean hearing gain was calculated by subtracting the postoperative air-bone gap from the preoperative air-bone gap.
A greater reduction in air-bone gap indicated better hearing improvement after tympanoplasty.
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3 months after surgery
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Graft uptake rate after tympanoplasty
Zeitfenster: 3 months after surgery
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Graft uptake rate was assessed by otoscopic examination.
A successful graft uptake was defined as an intact and correctly positioned graft with closure of the tympanic membrane perforation, without evidence of graft rejection or active infection.
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3 months after surgery
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Complete Air-Bone Gap Closure
Zeitfenster: 3 months after surgery
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Complete air-bone gap closure was defined as a postoperative air-bone gap of 10 dB or less on pure-tone audiometry.
This outcome was used to assess clinically meaningful improvement in conductive hearing loss after tympanoplasty.
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3 months after surgery
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Hafiz Adil Ikram, Shaikh Zayed Hospital, Lahore
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
- ShaikhZayedH2
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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