[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"suppurative-otitis-media\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:suppurative-otitis-media":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":4},"100657050","does-adding-a-fascial-layer-to-the-cartilage-in-tympanoplasty-for-large-tympanic-membrane-perforation-affect-the-overall-results-100657050",false,"NCT07834892","Does Adding a Fascial Layer to the Cartilage in Tympanoplasty for Large Tympanic Membrane Perforation Affect the Overall Results?","Does Adding a Fascial Layer to the Cartilage in Tympanoplasty for Large Tympanic Membrane Perforation Affect the Overall Results? (Comparative Study)","Inclusion Criteria:\n\n* Age 18 years and older\n* Presence of a large or subtotal tympanic membrane perforation\n* Safe chronic suppurative otitis media (CSOM)\n* Undergoing primary or revision tympanoplasty\n\nExclusion Criteria:\n\n* Unsafe ear (e.g., presence of cholesteatoma, marginal perforation, or attic pathology)\n* Small or medium-sized tympanic membrane perforations\n* Age younger than 18 years\n* Patients unwilling or unable to attend scheduled postoperative follow-up visits through 6 months","ALL","18 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"NA","Large tympanic membrane (eardrum) perforations present a surgical challenge and are historically associated with lower graft take rates compared to smaller perforations. While autologous cartilage provides durable structural support and resistance to retraction, surgeons differ on whether placing an additional layer of temporalis fascia over the cartilage graft improves anatomical closure and functional hearing.\n\nThe primary purpose of this study is to determine whether adding a temporalis fascia layer to a conchal cartilage and perichondrium graft improves graft healing rates and audiological outcomes in patients undergoing tympanoplasty for large or subtotal perforations.\n\nAdult participants with safe chronic suppurative otitis media and large or subtotal tympanic membrane perforations are randomly assigned in a 1:1 ratio to one of two surgical arms:\n\n* Group A:Tympanoplasty using an autologous conchal cartilage graft with attached perichondrium alone.\n* Group B: Tympanoplasty using an autologous conchal cartilage and perichondrium graft reinforced with an additional outer layer of temporalis fascia placed between the cartilage and the tympanic membrane remnant.\n\nAll participants undergo clinical otomicroscopy\u002Fotoendoscopy to assess graft take, healing, and complications, alongside pure-tone audiometry (evaluating air-bone gap and hearing thresholds) preoperatively and at 6 months postoperatively.",[26,27,28,29],"Tympanic Membrane Perforation","Otitis Media","Suppurative Otitis Media","Chronic Suppurative Otitis Media",[31,32,33,34,35,36,37],"Tympanoplasty","Cartilage Tympanoplasty","Temporalis Fascia","Conchal Cartilage","Myringoplasty","Air-Bone Gap","Graft Take","NOT_YET_RECRUITING","2026-09-17",{"date":41,"type":42},"2026-09-22","ACTUAL",{"date":44,"type":20},"2026-10",{"date":46,"type":20},"2027-11",{"name":48,"class":49},"Assiut University","OTHER"]