Actively Recruiting
Chlorhexidine Antiseptic Irrigation of the Bowel Segment During Radical Cystectomy and Urinary Diversion
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-12-15
23
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
Sponsors
I
Icahn School of Medicine at Mount Sinai
Lead Sponsor
I
Irrimax Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Chlorhexidine Antiseptic Irrigation of the Bowel Segment During Radical Cystectomy and Urinary Diversion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness and availability to comply with all study procedures, including twice daily irrigation of neobladder or ileal conduit
- Male or female, 18 years of age or older
- Confirmed diagnosis of bladder cancer
- Candidate for radical cystectomy with urinary diversion
- ECOG performance status of 0 to 2
- Serum creatinine level less than or equal to 1.5 mg/dL
You will not qualify if you...
- Has undergone or plans to undergo urinary diversion other than ileal conduit or neobladder
- Pregnancy or breastfeeding
- Known allergy to chlorhexidine or components of the Irrisept irrigation system
- Uncontrolled illnesses such as active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social conditions that may limit study compliance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
Research Team
M
Monali Fatterpekar, PhD
CONTACT
S
Sagar Shah, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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