[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569759":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":18,"responsibleParty":39,"collaborators":41,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":18,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":18,"enrollmentInfo":54,"targetDuration":18,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":69,"whyStopped":18,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":18},{"fullName":5,"class":6},"University of Florida","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"RADA16 Group","EXPERIMENTAL","Participants will undergo canal wall down mastoidectomy in standard fashion. All participants will have absorbable gelatin sponge placed into the mastoid cavity which is standard care. Only participants in this arm will receive RADA16 gel into the mastoid cavity before placement of the gelatin sponge.",[13],"Device: RADA16 gel application into mastoid cavity",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","NO_INTERVENTION","Participants will undergo canal wall down mastoidectomy in standard fashion. All participants will have absorbable gelatin sponge placed into the mastoid cavity which is standard care. Participants in this arm will not receive RADA16 gel.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","RADA16 gel application into mastoid cavity","A single application of RADA16 gel will be applied along the surface of the mastoid cavity intraoperatively prior to insertion of gelatin sponge packing. Application will involve a thin layer of gel just enough to cover the entire surface of the cavity.",[9],[26],"PuraGel",[28],{"name":29,"affiliation":5,"role":30},"Rex Haberman, MD","PRINCIPAL_INVESTIGATOR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":18,"email":36},"Braeden Lovett, MD","CONTACT","240-672-8082","braedenlovett@ufl.edu",{"name":29,"role":34,"phone":18,"phoneExt":18,"email":38},"rex.haberman@ent.ufl.edu",{"type":40,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[42],{"name":43,"class":44},"3-D Matrix UK Ltd.","INDUSTRY","100569759","rada16-on-mastoid-cavity-epithelialization-100569759",false,"NCT06698419","RADA16 on Mastoid Cavity Epithelialization","A Prospective Study: The Effect of RADA16 on Mastoid Cavity Epithelialization After Canal Wall Down Mastoidectomy","Inclusion Criteria:\n\n* English-speaking adults over the age of 18 years who require a canal wall down mastoidectomy for any reason including cholesteatoma, chronic suppurative middle ear disease, and neoplasm.\n* Participants with history of canal wall up mastoidectomy who now require canal wall down mastoidectomy for any reason.\n\nExclusion Criteria:\n\n* History of chronic immunodeficiency and autoimmune disease\n* History of head and neck radiation\n* Active tobacco use\n* History of coronary artery disease\n* History of peripheral vascular disease\n* History of diabetes mellitus\n* Known allergy to RADA16 gel or its components\n* Vulnerable populations including children, neonates, pregnant women, prisoners, institutionalized individuals, and other individuals who are unable to provide informed consent","ALL","18 Years",{"count":55,"type":56},14,"ESTIMATED","INTERVENTIONAL",[59],"NA","The goal of this clinical trial is to see if the application of RADA16 gel can expedite and improve the healing process in participants after canal wall down mastoidectomy. The main questions are:\n\n* Does application of RADA16 in the mastoid cavity after canal wall down mastoidectomy lead to faster healing (i.e. epithelialization)?\n* Is application of RADA16 in the mastoid cavity after canal wall down mastoidectomy associated with a decreased need for medications after surgery (i.e. antibiotics, steroids), less frequent in-office debridements, and less postoperative appointments?\n\nResearchers will compare the healing outcomes in participants treated with RADA16 gel to those in a control group who do not receive the treatment.\n\nParticipants will:\n\n* Undergo canal wall down mastoidectomy as recommended regardless of participation in the clinical trial\n* Follow-up postoperatively for clinical assessment at 1 month, 2 months, 3 months, 6 months, 1 year, 18 months, and 2 years. Participants may follow-up more frequently as needed.",[62],"Delayed Wound Healing",[64,65,66,67,68],"Mastoidectomy","Healing","Biologic","Mastoid cavity","Mastoid cavity disease","NOT_YET_RECRUITING","2024-11-18",{"date":72,"type":73},"2024-11-21","ACTUAL",{"date":75,"type":56},"2025-01-01",{"date":77,"type":56},"2027-01-01",{"name":5,"class":6}]