Using chlorhexidine to reduce infections after bladder cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study investigates the use of chlorhexidine irrigation during and after radical cystectomy with urinary diversion to improve urine sterilization and reduce urinary tract infections (UTIs). Patients will receive intra-operative irrigation of the bowel segment with Irrisept® and will continue with daily irrigation for a specified duration post-surgery. The study aims to assess the effectiveness of this intervention by measuring the incidence of symptomatic UTIs within 30 days after the procedure. The research will also evaluate the rate of urine sterilization at 10 days post-cystectomy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Mount Sinai Hospital
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: John P Sfakianos, MD — Associate Professor of Urology
• Study coordinator: Monali Fatterpekar, PhD
• Email: monali.fatterpekar@mountsinai.org
• Phone: (212) 241-0751

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Bladder cancer: test a biomarker-guided plan after neoadjuvant therapy

  This phase 2 study tests a biomarker- and response-guided plan to preserve the bladder in patients with muscle-invasive bladder cancer after neoadjuvant therapy.

  Recruiting Phase 2 Fox Chase Cancer Center · Philadelphia, Pennsylvania · NCT07908979

• Urinary Cell-Free DNA Test for Urothelial Cancer Origin

  This study tests a urine-based cell-free DNA test to help diagnose urothelial cancer and identify whether it started in the bladder or upper urinary tract in adults.

  Recruiting Ruijin Hospital · Shanghai · NCT07888374

• BL-M07D1: T-bren vs standard platinum chemo for HER2-expressing metastatic urothelial cancer after anti-PD-(L)1 therapy

  This trial tests whether T-bren can help people with HER2-expressing metastatic urothelial cancer who progressed after anti-PD-(L)1 therapy, compared with standard platinum-based chemotherapy.

  Recruiting at 2 sites Phase 3 SystImmune Inc. · Macon, Georgia and 1 other locations · NCT07869836

• Sac-TMT and pembrolizumab with chemoradiation for bladder muscle invasion

  This trial tests whether adding Sac-TMT and pembrolizumab to chemoradiation helps people with muscle-invasive bladder cancer live longer without the cancer growing or returning.

  Recruiting at 10 sites Phase 3 Merck Sharp & Dohme LLC · Kaohsiung City and 9 other locations · NCT07829783

• Personalized 3D Tumoroids from Your Tumor to Test Treatments

  Researchers are using patient tumor tissue and blood to grow personalized 3D, vascularized tumoroids with autologous immune cells to help tailor treatments for kidney, bladder, and prostate cancers.

  Recruiting University Hospital, Strasbourg, France · Strasbourg · NCT07820566

• Irreversible Electroporation for Recurrent Pelvic Tumors

  This study tests whether using irreversible electroporation (IRE) is safe and helps control recurrent pelvic tumors in adults who can’t have other local treatments.

  Recruiting Amsterdam UMC, location VUmc · Amsterdam, North Holland · NCT07782164

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.