Clinical trial NCT05282810: Cartilage Versus Temporalis Fascia Graft in Tympanoplasty for Recurrent Tympanic Membrane Perforation '' Comparative Study ''
Official title: Cartilage Versus Temporalis Fascia Graft in Tympanoplasty for Recurrent Tympanic Membrane
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tympanic Membrane Perforation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be randomly divided into Group 1, where only temporalis fascia alone will be used as a graft and Group 2, where cartilage will be used along with temporalis fascia graft.

Patients will be followed up and examined at 2 and 6 month to assess

1. graft take up (healing)
2. pure tone audiometry( hearing )

Brief summary: Use of Cartilage Versus Temporalis Fascia as a Graft in Tympanoplasty for Recurrent Tympanic Membrane Perforation

Detailed description: The main aim of successful tympanoplasty is to create a well aerated closed cavity after total removal of the disease. Numerous types of grafting materials have been used for closure of the tympanic membrane including fascia, periosteum, perichondrium, cartilage, vein, skin, and fat tissue . Autografts are thought to be the most compatible grafting materials with the best surgical results in tympanoplasty Temporal muscle fascia is composed of irregularly arranged elastic fibers and fibrous connective tissue. For this reason postoperative dimensions of temporal muscle fascia are unpredictable.

Cartilage has a constant shape, firmer than fascia and also lack fibrous tissue, so that postoperative dimensions remains the same and beside this, it is also nourished by diffusion and show great adaptation with TM . These advantages make the cartilage graft more preferable by otologists recently.

the use of cartilage graft in many different ways such as perichondrium cartilage island technique, palisade technique or cartilage reinforcement technique

Eligibility criteria: Inclusion Criteria:

* patients with safe chronic suppurative otitis media patient with recurrent perforation patirnt with coductive hearing loss

Exclusion Criteria:

* sensorineural hearing loss active infection compromised immune system

Primary outcomes:
measure: Cartilage Versus Temporalis Fascia Graft in Tympanoplasty for Recurrent Tympanic Membrane Perforation '' Comparative Study ''
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Jalali MM, Motasaddi M, Kouhi A, Dabiri S, Soleimani R. Comparison of cartilage with temporalis fascia tympanoplasty: A meta-analysis of comparative studies. Laryngoscope. 2017 Sep;127(9):2139-2148. doi: 10.1002/lary.26451. Epub 2016 Dec 9.
citation: Shakya D, Nepal A. Long-term results of type I tympanoplasty with perichondrium reinforced cartilage palisade vs temporalis fascia for large perforations: A retrospective study. J Otol. 2021 Jan;16(1):12-17. doi: 10.1016/j.joto.2020.07.004. Epub 2020 Jul 29.