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NCT06689176 | RECRUITING | Bladder Cancer

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

Icahn School of Medicine at Mount Sinai

Information provided by (Responsible Party):

Sfakian

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.

Condition or disease

Bladder Cancer

Urinary Tract Infection

Intervention/treatment

Irrisept® Antimicrobial Wound Lavage

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Chlorhexidine Antiseptic Irrigation of the Bowel Segment During Radical Cystectomy and Urinary Diversion After Chlorhexidine Irrigation in Patients Undergoing Radical Cystectomy
Actual Study Start Date : 2024-08-01
Estimated Primary Completion Date : 2025-08-01
Estimated Study Completion Date : 2025-08-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Chlorhexidine Antiseptic Irrigation of the Bowel Segment During Radical Cystectomy and Urinary Diversion

Location Details

NCT06689176

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Locations

RECRUITING

United States, New York

Mount Sinai Hospital

New York, New York, United States, 10029