Role of Hyaluronic Acid Gel as an Adjunct to Temporalis Facia Graft in Tympanoplasty for Total Tympanic Membrane Perforation
NCT ID: NCT07233226
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2023-01-25
2025-09-25
Brief Summary
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Study Design: A prospective single blinded randomized controlled trial that will be carried out on 60 cases with total tympanic membrane perforation who will undergo tympanoplasty at our tertiary referral center. All involved cases will have grade IV tympanic membrane perforation based on Saliba classification for tympanic membrane perforation.
The patients will be randomly divided into 2 groups A and B. Patients in group A will undergo underlay tympanoplasty using temporalis fascia graft with the utilization of hyaluronic acid gel was used as an adjunct to temporalis fascia graft. Patients in group B will undergo classic underlay tympanoplasty using temporalis fascia graft.
The two group will be compared as regards:
1. Graft success rate.
2. Hearing outcome
3. Surgical complications
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Detailed Description
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Study Design: A prospective single blinded randomized controlled trial that will be carried out on 60 cases with total tympanic membrane perforation who will undergo tympanoplasty at our tertiary referral center. Prior to study conduction, institutional ethics committee approval was obtained (code: MS.19.04.576). Informed written consents well be obtained from all cases before surgeries.
All involved cases will have grade IV tympanic membrane perforation based on Saliba classification for tympanic membrane perforation where the perforation was total perforation involving the entire four quadrants of the tympanic membrane. All the cases will have inactive dry ear for at least 2 months prior to surgeries. All involved cases will be ≥18 years old. Excluded cases include revision cases, cases with active (discharging ear), cases \< 18 years old, immunocompromised cases and cases who missed to follow up.
The patients will be randomly divided into 2 groups A and B using computer generated block randomization. Patients in group A will undergo underlay tympanoplasty using temporalis fascia graft through postauricular approach with the utilization of hyaluronic acid gel was used as an adjunct to temporalis fascia graft. Patients in group B will undergo classic underlay tympanoplasty using temporalis fascia graft through postauricular approach.
The two group will be compared as regards:
1. Graft success rate.
2. Hearing outcome
3. Surgical complications
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tympanoplasty using hyaluronic acid gel as an adjunct to temporalis fascia
Tympanoplasty using hyaluronic acid gel as an adjunct to temporalis fascia
Underlay tympanoplasty through postauricular approach using hyaluronic acid gel that will be added to the temporalis fascia graft as well as the perforation edges
Tympanoplasty using temporalis fascia
Tympanoplasty using temporalis fascia
Underlay tympanoplasty through postauricular approach using temporalis fascia
Interventions
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Tympanoplasty using hyaluronic acid gel as an adjunct to temporalis fascia
Underlay tympanoplasty through postauricular approach using hyaluronic acid gel that will be added to the temporalis fascia graft as well as the perforation edges
Tympanoplasty using temporalis fascia
Underlay tympanoplasty through postauricular approach using temporalis fascia
Eligibility Criteria
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Inclusion Criteria
* Inactive dry ear for at least 2 months prior to surgeries.
Exclusion Criteria
* Cases who missed to follow up.
* Cases with active (discharging) ear.
* Immunocompromised cases.
18 Years
ALL
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Ahmed Hemdan
Assistant Professor of Otorhinolaryngology
Locations
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Otorhinolaryngology Department, Faculty of Medicine, Mansoura University
Al Mansurah, Dakahlia Governorate, Egypt
Countries
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Other Identifiers
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MS.22.01.1835
Identifier Type: -
Identifier Source: org_study_id
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