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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07233226
Enrollment
60
Registered
2025-11-18
Start date
2023-01-25
Completion date
2025-09-25
Last updated
2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tympanoplasty

Keywords

hyaluronic acid gel, tympanoplasty, total tympanic membrane perforation

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

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

Interventions

PROCEDURETympanoplasty 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

PROCEDURETympanoplasty using temporalis fascia

Underlay tympanoplasty through postauricular approach using temporalis fascia

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Graft success6 monthsPrescence of an intact non-retracted tympanic membrane

Secondary

MeasureTime frameDescription
Hearing improvement6 monthsReduction of postoperative mean air conduction threshold and air bone gap in comparison to the preoperative results

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026