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Completed

NCT Number: NCT07233226

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

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

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Key information

Conditions

Tympanoplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Otorhinolaryngology Department, Faculty of Medicine, Mansoura University

Al Mansurah, Dakahlia Governorate, 35511, Egypt

About this study

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:

  • Graft success rate.
  • Hearing outcome
  • Surgical complications

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 temporalis fascia

Procedure

Underlay tympanoplasty through postauricular approach using temporalis fascia

Primary outcomes

  1. Graft success

    Time frame: 6 months

    Prescence of an intact non-retracted tympanic membrane

Secondary outcomes

  1. Hearing improvement

    Time frame: 6 months

    Reduction of postoperative mean air conduction threshold and air bone gap in comparison to the preoperative results

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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