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RECRUITING
NCT06689176
NA

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

Sponsor: Icahn School of Medicine at Mount Sinai

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

23

Start Date

2024-08-01

Completion Date

2026-07-01

Last Updated

2025-12-15

Healthy Volunteers

No

Interventions

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