This phase II trial tests how well chlorhexidine gluconate (Irrisept, registered trademark) bladder irrigation works in reducing urinary tract infections (UTIs) in patients with bladder cancer undergoing surgery to remove the bladder (radical cystectomy) and urinary diversion. UTIs are the most common complication after radical cystectomy and are responsible for over half of the readmissions to the hospital. Antiseptic solutions, such as chlorhexidine, are commonly used to reduce bacterial contamination in wounds. Irrisept is a device containing chlorhexidine gluconate intended for cleansing and removal of debris and foreign materials, including microorganisms from wounds. Bladder irrigation with using Irrisept may reduce the rate of urinary tract infections in patients with bladder cancer undergoing radical cystectomy with urinary diversion.
Additional locations may be listed on ClinicalTrials.gov for NCT06689176.
Locations matching your search criteria
United States
New York
New York
Icahn School of Medicine at Mount SinaiStatus: Active
Contact: John Sfakianos
PRIMARY OBJECTIVES:
I. To estimate the rate of negative urine cultures at 30 ± 7 days from patients with urinary diversion.
II. To estimate the proportion of participants with incident UTI by 30 ± 7 days post radical cystectomy with urinary diversion.
SECONDARY OBJECTIVES:
I. Evaluation of safety of instillation of chlorhexidine antiseptic solution for irrigation of neobladders and ileal conduits.
II. Any complications of Clavien Dindo grade III or higher.
III. Need for antibiotic therapy.
IV. Occurrence of symptomatic UTI.
OUTLINE:
Patients undergo standard of care (SOC) radical cystectomy with urinary diversion on day 0 and receive Irrisept irrigation intraoperatively and then via neobladder or ileal conduit for 1 minute twice daily (BID) for up to 30 days in the absence of unacceptable toxicity. Additionally, patients undergo computed tomography (CT) or magnetic resonance imaging (MRI) during screening and blood and urine sample collection on study.
After completion of study treatment, patients are followed for up to 30 days.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationIcahn School of Medicine at Mount Sinai
Principal InvestigatorJohn Sfakianos
