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

NCT07233226 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-11-20

No results posted yet for this study

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

Conditions

  • Tympanoplasty

Interventions

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

PROCEDURE

Tympanoplasty using temporalis fascia

Underlay tympanoplasty through postauricular approach using temporalis fascia

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-25
Primary Completion
2025-08-20
Completion
2025-09-25

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07233226 on ClinicalTrials.gov