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RECRUITINGINTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Provision of signed and dated willing to sign a consent form 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 - You should be able to carry out daily activities with 0 level of ability (ECOG 0)-2 - Serum creatinine ≤ 1.5 mg/dL Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DEVICE

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.

Locations (1)

Mount Sinai Hospital
New York, New York, United States