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

Last updated: November 12, 2024
Sponsor: Icahn School of Medicine at Mount Sinai
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bladder Cancer

Bladder Disorders

Enuresis

Treatment

Irrisept® Antimicrobial Wound Lavage

Clinical Study ID

NCT06689176
STUDY-23-00340
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Provision of signed and dated informed consent form.

  • Stated availability for the duration of the study, and willingness to comply withall study procedures, including willingness to adhere to twice daily irrigation ofneobladder 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

Exclusion Criteria:

  • Has undergone or planned to undergo urinary diversion other than ileal conduit orneobladder.

  • Pregnancy or lactation.

  • Known allergic reactions to components of the Irrisept irrigating system,chlorhexidine.

  • Patient must not have any uncontrolled intercurrent illness including, but notlimited to, ongoing or active infection, symptomatic congestive heart failure,unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/socialsituations that, in the opinion of the investigator, would limit compliance withstudy requirements.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Irrisept® Antimicrobial Wound Lavage
Phase:
Study Start date:
August 01, 2024
Estimated Completion Date:
August 01, 2025

Study 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.

Connect with a study center

  • Mount Sinai Hospital

    New York, New York 10029
    United States

    Active - Recruiting

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