Recruiting

Chlorhexidine

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT06689176

Conditions

Bladder Cancer

Urinary Tract Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Irrisept® Antimicrobial Wound Lavage

Study Details

Brief summary:

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.

Conditions

Bladder Cancer

Urinary Tract Infection

Study ID

NCT06689176

Start date

Aug 1, 2024

Status verified date

Dec, 2025

Completion date

Jul 1, 2026

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

23 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Patients undergoing radical cystectomy with urinary diversion

Patients undergoing radical cystectomy and ileal conduit or ileal neobladder will receive Irrisept ® Antimicrobial Wound Lavage as intervention

Interventions

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.

Primary outcome measure

  • Number of participants that have negative urine culture [ Time Frame: 30 ± 7 days post radical cystectomy with urinary diversion. ]
  • Proportion of participants with incident symptomatic UTI [ Time Frame: 30 ± 7 days post radical cystectomy with urinary diversion. ]

Central Contacts and Locations

Central contacts

Monali Fatterpekar, PhD

(212) 241-0751monali.fatterpekar@mountsinai.org

Sagar Shah, BS

(212) 241-0751sagar.shah@mountsinai.org

Locations

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

John Sfakianos, MD

John.Sfakianos@mountsinai.org

Principal Investigator:

John Sfakianos, MD

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Dec 15, 2025

Last verified

Dec, 2025

Keywords

  • Bladder Cancer
  • Radical Cystectomy
  • Ileal Conduit
  • Neobladder
  • Chlorhexidine Gluconate
  • Irrisept

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2025-12-15.