[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536114":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":49,"responsibleParty":82,"collaborators":85,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":44,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":44,"enrollmentInfo":98,"targetDuration":44,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":110,"overallStatus":52,"whyStopped":44,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Central Adelaide Local Health Network Incorporated","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Gelfoam Arm","ACTIVE_COMPARATOR","The current standard of care in middle ear packing material has been Gelfoam, Gelfoam is an absorbable gelatin sponge manufactured from denatured porcine skin. Generally, Gelfoam resides within the middle ear for 2 to 9 weeks prior to being degraded via phagocytosis.\n\nA single Gelfoam sponge is divided into small pieces and used within the ear. One piece of Gelfoam can typically be cut into over 200 smaller pieces. The surgeon uses approximately 10 to 20 of these smaller pieces per surgery. Approx a third of the product is applied into the middle ear, as a support material for the graft. After graft suturing is complete, the remaining two thirds are applied into the external ear canal as a packing agent.\n\nThe surgeon administers the foam during the surgery as they would with the standard TMP repair surgery. The product comes in a sterile package to be opened and cut up by Scrub Nurse.",[13],"Device: Gelfoam",{"label":15,"type":16,"description":17,"interventionNames":18},"Chitodex Arm","EXPERIMENTAL","Chitosan-dextran gel is packaged within a syringe and has a cannula attached, much like the Gelfoam syringe system. Approx 3-5mL of product is applied during the surgery. Approx 2mL into the middle ear, as a support material for the graft. After graft suturing is complete, another 3mL (approx) is applied into the external ear canal as a packing agent. This is the same procedure as Gelfoam is currently used for this purpose.\n\nThe surgeon will administer the gel during the surgery as they would with the standard of care Gelfoam. The product comes in a sterile kit to be opened by Scrub Nurse.",[19],"Device: Chitodex",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Gelfoam","GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is a water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine skin, Gelatin USP Granules and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids.",[9],[27],"Gelfoam® absorbable gelatin compressed sponge, USP",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Chitodex","The Chitogel Endoscopic Sinus Surgery Kit contains components and equipment for the preparation of a nasal gel to be applied to the sinus cavities via a supplied and specifically designed malleable cannula.\n\nThe Gel preparation will take approximately 30 minutes, so preparation must start sufficiently in advance of when the Gel is expected to be used in surgery.\n\nOnce the Gel has been prepared it should be applied to the sinus cavities on both sides within six hours using the malleable cannula supplied with the Kit.\n\nThe Gel must be prepared on a sterile surface following these instructions. There are two main components to the Gel.\n\n1. Dextran Aldehyde (B), which is a dry powder, and is reconstituted into a liquid form through mixing the powder with a liquid Sodium Phosphate Buffer (A). Both of these components are supplied sterile.\n2. The second component Chitosan Succinamide (C), is a liquid and is also supplied sterile.",[15],[33],"Chitosan-Dextran, Chitogel Endoscopic Sinus Surgery Kit",[35],{"name":36,"affiliation":37,"role":38},"Prof Peter-John Wormald, MD","Central Adelaide Local Health Network","PRINCIPAL_INVESTIGATOR",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Prof Peter-John Wormald, MD,","CONTACT","+61 8 82227158",null,"pjwormald@gmail.com",{"name":47,"role":42,"phone":43,"phoneExt":44,"email":48},"Emma Barry, BSc (Hons)","emma.barry@adelaide.edu.au",[50,70],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"The Queen Elizabeth Hospital","RECRUITING","Adelaide","South Australia","5011","Australia","AU",{"type":59,"coordinates":60},"Point",[61,62],138.59863,-34.92866,{"lat":62,"lon":61},[65,68,69],{"name":66,"role":42,"phone":67,"phoneExt":44,"email":45},"Prof Peter John Wormald, MD","+61 8 8222 7158",{"name":47,"role":42,"phone":67,"phoneExt":44,"email":48},{"name":66,"role":42,"phone":44,"phoneExt":44,"email":44},{"facility":71,"status":52,"city":72,"state":54,"zip":73,"country":56,"countryCode":57,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"The Memorial Hospital","North Adelaide","5006",{"type":59,"coordinates":75},[76,77],138.59141,-34.90733,{"lat":77,"lon":76},[80],{"name":66,"role":42,"phone":67,"phoneExt":44,"email":81},"prwormald@gmail.com",{"type":38,"investigatorFullName":83,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"Peter-John Wormald","Prof Peter John Wormald MD, FAHMS, FRACS, FACS, FCS(SA), FRCS (Ed), MBChB Chairman Otolaryngology Head and Neck Surgery Professor of Skull Base Surgery , CAHLN and University of Adelaide",[86],{"name":87,"class":88},"University of Adelaide","OTHER","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":99,"type":100},44,"ESTIMATED","INTERVENTIONAL",[103],"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.",[106,107,108,109],"Tympanic Membrane Perforation","Tympanic Membrane Inflammation","Surgery","Otitis Media",[111,112,113,114,115,116,117,118,119,120,121,122],"tympanic membrane","surgery","single blinded","chitogel","chitosan-dextran","otitis media","gelfoam","medical device","chitodex","myringoplasty","mastoidectomy","ossiculoplasty","2024-11-11",{"date":125,"type":126},"2024-11-13","ACTUAL",{"date":128,"type":126},"2021-11-20",{"date":130,"type":100},"2025-05-13",{"name":5,"class":6},2]