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

Role of Hyaluronic Acid in Type I Tympanoplasty for Total and Subtotal Tympanic Membrane Perforations

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. Graft success rate.
2. Hearing outcome
3. Surgical complications

Study Overview

• Status: Completed
• Conditions: Tympanoplasty
• Intervention / Treatment: Procedure: Tympanoplasty using hyaluronic acid gel as an adjunct to temporalis fascia; Procedure: Tympanoplasty using temporalis fascia

Detailed Description

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. 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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia Governorate
    • Al Mansurah, Dakahlia Governorate, Egypt, 35511
      • Otorhinolaryngology Department, Faculty of Medicine, Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tympanoplasty using hyaluronic acid gel as an adjunct to temporalis fascia	Procedure: 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
Experimental: Tympanoplasty using temporalis fascia	Procedure: Tympanoplasty using temporalis fascia; Underlay tympanoplasty through postauricular approach using temporalis fascia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft success	Prescence of an intact non-retracted tympanic membrane	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hearing improvement	Reduction of postoperative mean air conduction threshold and air bone gap in comparison to the preoperative results	6 months

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2023
• Primary Completion (Actual): August 20, 2025
• Study Completion (Actual): September 25, 2025

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Estimated): November 18, 2025

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: tympanoplasty; hyaluronic acid gel; total tympanic membrane perforation
• Other Study ID Numbers: MS.22.01.1835

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No