TympanoplastyNCT07233226
Role of Hyaluronic Acid Gel as an Adjunct to Temporalis Facia Graft in Tympanoplasty for Total Tympanic Membrane Perforation
A study testing Tympanoplasty using hyaluronic acid gel as an adjunct to temporalis fascia and Tympanoplasty using temporalis fascia in people with Tympanoplasty, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tympanoplasty
- What is being tested?
- Tympanoplasty using hyaluronic acid gel as an adjunct to temporalis fascia and Tympanoplasty using temporalis fascia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jan 2023to 25 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Grade IV tympanic membrane perforation based on Saliba classification for tympanic membrane perforation.
- Inactive dry ear for at least 2 months prior to surgeries.
Who cannot join
- Revision cases.
- Cases who missed to follow up.
- Cases with active (discharging) ear.
- Immunocompromised cases.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Otorhinolaryngology Department, Faculty of Medicine, Mansoura University
Al Mansurah, Dakahlia Governorate, 35511
About this study
Official title: 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.
Read more
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:
- Graft success rate.
- Hearing outcome
- Surgical complications
Read the 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:
- Graft success rate.
- Hearing outcome
- Surgical complications
- Conditions
- Tympanoplasty
- Being tested
- Tympanoplasty using hyaluronic acid gel as an adjunct to temporalis fascia, Tympanoplasty using temporalis fascia
- Keywords
- hyaluronic acid gel, tympanoplasty, total tympanic membrane perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tympanoplasty using hyaluronic acid gel as an adjunct to temporalis fasciaProcedure or surgery
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 fasciaProcedure or surgery
Underlay tympanoplasty through postauricular approach using temporalis fascia
| Study group | Role | What they receive |
|---|---|---|
| Tympanoplasty using hyaluronic acid gel as an adjunct to temporalis fascia | Experimental | Not described Receives: Procedure: Tympanoplasty using hyaluronic acid gel as an adjunct to temporalis fascia |
| Tympanoplasty using temporalis fascia | Experimental | Not described Receives: Procedure: Tympanoplasty using temporalis fascia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft success
Prescence of an intact non-retracted tympanic membrane
Measured: 6 months
Secondary outcomes (1)
Hearing improvement
Reduction of postoperative mean air conduction threshold and air bone gap in comparison to the preoperative results
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start25 Jan 2023
- Primary completion20 Aug 2025
- Study completion25 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TympanoplastyStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hemdan, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233226
- Sponsor's protocol ID
- MS.22.01.1835
- Status last verified
- Oct 2025
- First submitted
- 14 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Hyaluronic Acid in Type I Tympanoplasty for Total and Subtotal Tympanic Membrane Perforations
- ClinicalTrials.gov ID
- NCT07233226
- Acronym / sponsor ID
- MS.22.01.1835
- Conditions
- Tympanoplasty
- Keywords
- hyaluronic acid gel, tympanoplasty, total tympanic membrane perforation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 20 Aug 2025 (actual)
- Study completion
- 25 Sep 2025 (actual)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Graft success rate.
- Hearing outcome
- 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:
- Graft success rate.
- Hearing outcome
- Surgical complications
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Grade IV tympanic membrane perforation based on Saliba classification for tympanic membrane perforation.
- Inactive dry ear for at least 2 months prior to surgeries.
Key exclusion criteria (4 listed)
- Revision cases.
- Cases who missed to follow up.
- Cases with active (discharging) ear.
- Immunocompromised cases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tympanoplasty using hyaluronic acid gel as an adjunct to temporalis fasciaUnderlay tympanoplasty through postauricular approach using hyaluronic acid gel that will be added to the temporalis fascia graft as well as the perforation edges | Procedure or surgery | Tympanoplasty using hyaluronic acid gel as an adjunct to temporalis fascia |
| Tympanoplasty using temporalis fasciaUnderlay tympanoplasty through postauricular approach using temporalis fascia | Procedure or surgery | Tympanoplasty using temporalis fascia |
Primary outcome
Graft success
Time frame: 6 months
Prescence of an intact non-retracted tympanic membrane
1 secondary outcome
Hearing improvement
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tympanoplasty using hyaluronic acid gel as an adjunct to temporalis fascia and Tympanoplasty using temporalis fascia in people with Tympanoplasty, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft success (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.