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Chlorhexidine Irrigation for Bladder Cancer Surgery

This study is looking at whether using Irrisept® Antimicrobial Wound Lavage, which contains 0.05% Chlorhexidine Gluconate (CHG), can help prevent urinary tract infections (UTIs) after bladder cancer surgery. If you are having a radical cystectomy (surgery to remove the bladder) with urinary diversion (creating a new way for urine to leave the body), you might be able to join. The study will use Irrisept® to wash the bowel segment during surgery and then for daily irrigation after surgery. Researchers will measure how many participants have sterile urine and how many get a UTI within about a month after surgery. This is a small study aiming to enroll 23 participants.

Study design
This is a single-arm pilot study, meaning all participants will receive the Irrisept® irrigation. It is designed to see if this treatment is promising for future, larger studies.
What's involved
You would need to agree to daily irrigation of your neobladder or ileal conduit for 10 to 21 days after surgery. You will also have your urine checked around 30 days after surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for about 30 days after their surgery to check for UTIs and urine sterility.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06689176

Chlorhexidine Antiseptic Irrigation of the Bowel Segment During Radical Cystectomy and Urinary Diversion

Recruiting
NAAges 18+InterventionalTreatment
Icahn School of Medicine at Mount Sinai
~23 participants
Updated 2025-12-15 on ClinicalTrials.gov
What's tested:Irrisept® Antimicrobial Wound Lavage

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants that have negative urine culture
Measured over 30 ± 7 days post radical cystectomy with urinary diversion.
+1 more outcome measured

Conditions

Bladder Cancer
Urinary Tract Infection

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NCT06689176

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mount Sinai Hospital

    New York, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • John P Sfakianos, MD · PRINCIPAL_INVESTIGATOR · Associate Professor of Urology

Who to contact

Monali Fatterpekar, PhD
[email protected]
(212) 241-0751
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of participants that have negative urine culture30 ± 7 days post radical cystectomy with urinary diversion.

    Negative urine culture will be defined as a colony count of less than or equal to 100000 CFU/ml. The urine sample will be collected by catheterization of the conduit with a 16F Foley catheter, which provides the least number of CFU of bacteria compared to collection from the ostomy bag. Patients with ileal neobladder will give a spontaneously voided urine sample when able or will be obtained from catheterized urine for those who cannot void.

  • Proportion of participants with incident symptomatic UTI30 ± 7 days post radical cystectomy with urinary diversion.

    Proportion of participants with incident symptomatic UTI by 30 ± 7 days post radical cystectomy with urinary diversion. Symptomatic UTI will be defined as a positive urine culture in the presence of fever (≥38°C) with or without associated flank/abdominal pain.