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NCT Number: NCT06689176

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital

New York, 10029, United States

Location status: Recruiting

Location contact

John Sfakianos, MD

CONTACT

[email protected]

John Sfakianos, MD

PRINCIPAL_INVESTIGATOR

About this study

Th research team proposes to increase the rate of sterilization of urine from patients with urinary diversion and reduce the incidence of UTI up to 30 ± 7 days post radical cystectomy and urinary diversion using 50 ± 25ml of Irrisept ® irrigation solution lavage of the bowel segment during surgery for a contact time of 2 minutes. For patients who obtain an ileal conduits irrigation using 50 ± 25ml of Irrisept ® will be performed daily for 10 days +/- 3 days and for those patients obtaining ileal neobladders irrigation using 50 ± 25ml of Irrisept ® will continue for 21 days +/- 7 days. The irrigation will continue for the given time described above as this is usually when stents and catheters are removed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Irrisept® Antimicrobial Wound Lavage

Device

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 outcomes

  1. Number of participants that have negative urine culture

    Time frame: 30 ± 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.

  2. Proportion of participants with incident symptomatic UTI

    Time frame: 30 ± 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.

Secondary outcomes

  1. Percentage of urine leak from neobladder/ ileal conduit

    Time frame: 30 ± 7 days post radical cystectomy with urinary diversion

  2. Percentage of patients with sepsis

    Time frame: 30 ± 7 days post radical cystectomy with urinary diversion

    Percentage of patients with sepsis (when the body reacts to an infection) will be assessed. In case >/= 10% of participants experience sepsis, the intervention will be considered unacceptable.

  3. Percentage of symptomatic urinary tract infections

    Time frame: 30 ± 7 days post radical cystectomy with urinary diversion

    Symptomatic urinary tract infection is when a person has positive UTI and has fever and other symptoms including pain when passing urine and pain in the lower belly.

Study contacts

Contact information is provided by the study sponsor or research team.

Monali Fatterpekar, PhD

CONTACT

[email protected]

(212) 241-0751

Sagar Shah, BS

CONTACT

[email protected]

(212) 241-0751

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Irrimax Corporation

Registry information

Official study title

Chlorhexidine Antiseptic Irrigation of the Bowel Segment During Radical Cystectomy and Urinary Diversion After Chlorhexidine Irrigation in Patients Undergoing Radical Cystectomy

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 14, 2024
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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