An interventional study of Tympanoplasty using hyaluronic acid gel as an adjunct to temporalis fascia and Tympanoplasty using temporalis fascia in Tympanoplasty, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-20.
Sponsored by Mansoura University · Not applicable, Interventional, and Treatment
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:
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:
Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Procedure: Tympanoplasty using hyaluronic acid gel as an adjunct to temporalis fascia
Procedure: Tympanoplasty using 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
Underlay tympanoplasty through postauricular approach using temporalis fascia
Graft success
Prescence of an intact non-retracted tympanic membrane
Time frame: 6 months
Hearing improvement
Reduction of postoperative mean air conduction threshold and air bone gap in comparison to the preoperative results
Time frame: 6 months
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Mansoura University