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

NCT06689176 | Recruiting FDA Device

• 1 other identifier: STUDY-23-00340
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Number of participants that have negative urine culture

  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.

  30 ± 7 days post radical cystectomy with urinary diversion.

• Proportion of participants with incident symptomatic UTI

  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.

  30 ± 7 days post radical cystectomy with urinary diversion.

Secondary Outcomes (3)

• Percentage of urine leak from neobladder/ ileal conduit

  30 ± 7 days post radical cystectomy with urinary diversion

• Percentage of patients with sepsis

  30 ± 7 days post radical cystectomy with urinary diversion

• Percentage of symptomatic urinary tract infections

  30 ± 7 days post radical cystectomy with urinary diversion

Study Arms (1)

Patients undergoing radical cystectomy with urinary diversion

EXPERIMENTAL

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

Device: Irrisept® Antimicrobial Wound Lavage

Interventions

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.

Patients undergoing radical cystectomy with urinary diversion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Irrimax Corporation: collaborator

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Infections

Study Officials

• John P Sfakianos, MD

  Associate Professor of Urology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monali Fatterpekar, PhD

CONTACT

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

Sagar Shah, BS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Urology

Model Details: This is single center, open-label study where the participants will be identified from the principal investigator and sub-investigator's clinic. All the participants who meet the study criteria and sign the consent form will be assigned to the study intervention.

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 14, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose. Any purpose. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (TBD).

Locations

US (1)