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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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * Provision of signed and dated informed consent form. * 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. * Male or female, ≥ 18 years of age * Confirmed diagnosis of bladder cancer * Candidate for radical cystectomy with urinary diversion * ECOG performance status of 0-2 * Serum creatinine ≤ 1.5 mg/dL Exclusion Criteria: * Has undergone or planned to undergo urinary diversion other than ileal conduit or neobladder. * Pregnancy or lactation. * Known allergic reactions to components of the Irrisept irrigating system, chlorhexidine. * 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/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
About the study
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.
What is being tested
- Irrisept® Antimicrobial Wound Lavage (device)
Sponsor: Icahn School of Medicine at Mount Sinai · Participants: 23 · Started: Aug 1, 2024
Contact the study team
- Monali Fatterpekar, PhD · Phone: (212) 241-0751
- Sagar Shah, BS · Phone: (212) 241-0751
Official record on ClinicalTrials.gov — NCT06689176
Locations in the U.S.
| New York | Mount Sinai Hospital, New York |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.