Role of Hyaluronic Acid Gel as an Adjunct to Temporalis Facia Graft in Tympanoplasty for Total Tympanic Membrane Perforation

NCT07233226 | Completed

• 1 other identifier: MS.22.01.1835
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: the aim of the study is to compare the results of tympanoplasty using hyaluronic acid gel as an adjunct to temporalis fascia graft with tympanoplasty using temporalis fascia graft. 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. 1.Graft success rate.
2. 2.Hearing outcome
3. 3.Surgical complications

Conditions

Tympanoplasty

Keywords

hyaluronic acid gel; tympanoplasty; total tympanic membrane perforation

Outcome Measures

Primary Outcomes (1)

• Graft success

  Prescence of an intact non-retracted tympanic membrane

  6 months

Secondary Outcomes (1)

• Hearing improvement

  6 months

Study Arms (2)

Tympanoplasty using hyaluronic acid gel as an adjunct to temporalis fascia

EXPERIMENTAL

Procedure: Tympanoplasty using hyaluronic acid gel as an adjunct to temporalis fascia

Tympanoplasty using temporalis fascia

EXPERIMENTAL

Procedure: Tympanoplasty using temporalis fascia

Interventions

Tympanoplasty using hyaluronic acid gel as an adjunct to temporalis fascia PROCEDURE

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 hyaluronic acid gel as an adjunct to temporalis fascia

Tympanoplasty using temporalis fascia PROCEDURE

Underlay tympanoplasty through postauricular approach using temporalis fascia

Tympanoplasty using temporalis fascia

Eligibility Criteria

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

You may qualify if:

• Grade IV tympanic membrane perforation based on Saliba classification for tympanic membrane perforation.
• Inactive dry ear for at least 2 months prior to surgeries.

You may not qualify if:

• Revision cases.
• Cases who missed to follow up.
• Cases with active (discharging) ear.
• Immunocompromised cases.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Otorhinolaryngology Department, Faculty of Medicine, Mansoura University

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Otorhinolaryngology

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: January 25, 2023
• Primary Completion: August 20, 2025
• Study Completion: September 25, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-10

Locations

EG (1)