[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tympanic-membrane-inflammation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tympanic-membrane-inflammation":27},{"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":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100536114","effect-of-chitodex-gel-in-tympanoplasty-surgery-100536114",false,"NCT06260618","Effect of Chitodex Gel in Tympanoplasty Surgery","A Single-blinded Randomised Trial Evaluating the Efficacy of Chitosan-dextran (Chitodex) Gel Versus Gelfoam Sponge Instillation Within the Middle Ear and External Auditory Canal During Tympanoplasty Surgery","Inclusion Criteria:\n\n1. Individuals who have otoscopic evidence of tympanic membrane perforation that is also confirmed by tympanometry (Defined as a Type B tympanogram, with elevated EAC volume) AND\n\n   1. The TM perforation is associated with at least 15dB of conductive hearing loss on the affected side AND\n   2. Are indicated to undergo closure of the perforation via tympanoplasty surgery\n2. OR Individuals who are indicated for ossiculoplasty due to ossicular chain disruption and its sequelae\n3. OR Individuals who are indicated for mastoidectomy for COM or its sequelae eg cholesteatoma\n4. Demonstrate healthy, dry middle ear mucosal cavities at time of surgery AND\n5. Are 18 years of age or over AND\n6. Are able to give written informed consent AND\n7. Are committed to returning for post-operative assessments at 2 and 6 weeks post-op, 3-, and 6- months post-op\n\nExclusion Criteria:\n\n1. Operative ear is the better or only hearing ear\n2. The ear has evidence of cholesteatoma or other middle ear tumour during otoscopic examination\n3. dysfunction during otoscopic and tympanometric examination\n4. Known allergy to shellfish or ciprofloxacin antibiotics\n5. Pregnant or breastfeeding\n6. Hepatitis, HIV or any blood disorders\n7. COVID-19 positive patients\n8. Contra-indications for MRI","ALL","18 Years",{"count":19,"type":20},44,"ESTIMATED","INTERVENTIONAL",[23],"NA","The general purpose of this study is to compare Chitosan-dextran (Chitodex) gel versus current standard of care, Gelfoam, as a middle ear (ME) and external auditory canal (EAC) packing agent as part of tympanoplasty, ossiculoplasty and mastoidectomy procedures.",[26,27,28,29],"Tympanic Membrane Perforation","Tympanic Membrane Inflammation","Surgery","Otitis Media",[31,32,33,34,35,36,37,38,39,40,41,42],"tympanic membrane","surgery","single blinded","chitogel","chitosan-dextran","otitis media","gelfoam","medical device","chitodex","myringoplasty","mastoidectomy","ossiculoplasty","RECRUITING","2024-11-11",{"date":46,"type":47},"2024-11-13","ACTUAL",{"date":49,"type":47},"2021-11-20",{"date":51,"type":20},"2025-05-13",{"name":53,"class":54},"Central Adelaide Local Health Network Incorporated","OTHER_GOV",2]