Using chlorhexidine to reduce infections after bladder cancer surgery
Chlorhexidine Antiseptic Irrigation of the Bowel Segment During Radical Cystectomy and Urinary Diversion After Chlorhexidine Irrigation in Patients Undergoing Radical Cystectomy
This study is testing if using chlorhexidine during and after bladder cancer surgery can help reduce urinary tract infections for patients recovering from the procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 23 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06689176 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of bladder cancer who are scheduled for radical cystectomy with urinary diversion.
Not a fit: Patients who have undergone or are planning to undergo urinary diversion other than ileal conduit or neobladder may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of urinary tract infections in patients undergoing bladder cancer surgery.
How similar studies have performed: While the specific use of chlorhexidine in this context is novel, similar antiseptic irrigation approaches have shown promise in reducing infection rates in surgical settings.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.