[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569048":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":54,"collaborators":56,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":20,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":20,"enrollmentInfo":69,"targetDuration":20,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":38,"whyStopped":20,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Icahn School of Medicine at Mount Sinai","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients undergoing radical cystectomy with urinary diversion","EXPERIMENTAL","Patients undergoing radical cystectomy and ileal conduit or ileal neobladder will receive Irrisept ® Antimicrobial Wound Lavage as intervention",[13],"Device: Irrisept® Antimicrobial Wound Lavage",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Irrisept® Antimicrobial Wound Lavage","Irrisept® Antimicrobial Wound Lavage is a single-use, manual, self-contained irrigation device comprised of a 450mL bottle of 0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation, United States Pharmacopeia (USP) and an applicator (labeled Irriprobe®). The solution is aseptically filled in a Blow-Fill-Seal (BFS) bottle. The CHG acts as a preservative to inhibit microbial growth in the solution.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"John P Sfakianos, MD","Associate Professor of Urology","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Monali Fatterpekar, PhD","CONTACT","(212) 241-0751","monali.fatterpekar@mountsinai.org",{"name":33,"role":29,"phone":30,"phoneExt":20,"email":34},"Sagar Shah, BS","sagar.shah@mountsinai.org",[36],{"facility":37,"status":38,"city":39,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Mount Sinai Hospital","RECRUITING","New York","10029","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-74.00597,40.71427,{"lat":47,"lon":46},[50,53],{"name":51,"role":29,"phone":20,"phoneExt":20,"email":52},"John Sfakianos, MD","John.Sfakianos@mountsinai.org",{"name":51,"role":25,"phone":20,"phoneExt":20,"email":20},{"type":25,"investigatorFullName":55,"investigatorTitle":24,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"John Sfakianos",[57],{"name":58,"class":59},"Irrimax Corporation","INDUSTRY","100569048","chlorhexidine-antiseptic-irrigation-of-the-bowel-segment-during-radical-cystectomy-and-urinary-diversion-100569048",false,"NCT06689176","Chlorhexidine Antiseptic Irrigation of the Bowel Segment During Radical Cystectomy and Urinary Diversion","Chlorhexidine Antiseptic Irrigation of the Bowel Segment During Radical Cystectomy and Urinary Diversion After Chlorhexidine Irrigation in Patients Undergoing Radical Cystectomy","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form.\n* Stated availability for the duration of the study, and willingness to comply with all study procedures, including willingness to adhere to twice daily irrigation of neobladder or ileal conduit.\n* Male or female, ≥ 18 years of age\n* Confirmed diagnosis of bladder cancer\n* Candidate for radical cystectomy with urinary diversion\n* ECOG performance status of 0-2\n* Serum creatinine ≤ 1.5 mg\u002FdL\n\nExclusion Criteria:\n\n* Has undergone or planned to undergo urinary diversion other than ileal conduit or neobladder.\n* Pregnancy or lactation.\n* Known allergic reactions to components of the Irrisept irrigating system, chlorhexidine.\n* Patient must not have any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that, in the opinion of the investigator, would limit compliance with study requirements.","ALL","18 Years",{"count":70,"type":71},23,"ESTIMATED","INTERVENTIONAL",[74],"NA","This is a single arm, interventional pilot study of using chlorhexidine irrigation intra-operatively and post-operatively among patients undergoing radical cystectomy with urinary diversion. The intervention comprises of using irrigation of ileal conduit or ileal neobladder intra-operatively and then for irrigation of either post-surgery with Irrisept ®. The sterilization of urine will be assessed at 10 days after cystectomy. Incidence of symptomatic urinary tract infections within the 30-day post-operative period will be estimated.",[77,78],"Bladder Cancer","Urinary Tract Infection",[77,80,81,82,83,84],"Radical Cystectomy","Ileal Conduit","Neobladder","Chlorhexidine Gluconate","Irrisept","2025-12-08",{"date":87,"type":88},"2025-12-15","ACTUAL",{"date":90,"type":88},"2024-08-01",{"date":92,"type":71},"2026-07-01",{"name":5,"class":6},1]