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

NCT ID: NCT06689176

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2026-07-01

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.

Detailed Description

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.

Conditions

Bladder Cancer; Urinary Tract Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Irrisept® Antimicrobial Wound Lavage

Intervention Type: 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.

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Irrimax Corporation

INDUSTRY

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

John Sfakianos

Associate Professor of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John P Sfakianos, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Urology

Locations

Mount Sinai Hospital

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Monali Fatterpekar, PhD

Role: CONTACT

monali.fatterpekar@mountsinai.org

(212) 241-0751

Sagar Shah, BS

Role: CONTACT

sagar.shah@mountsinai.org

(212) 241-0751

Facility Contacts

John Sfakianos, MD

Role: primary

John.Sfakianos@mountsinai.org

Other Identifiers

STUDY-23-00340

Identifier Type: -

Identifier Source: org_study_id