Actively Recruiting
Chlorhexidine Antiseptic Irrigation of the Bowel Segment During Radical Cystectomy and Urinary Diversion After Chlorhexidine Irrigation in Patients Undergoing Radical Cystectomy
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-12-15
23
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the use of chlorhexidine antiseptic irrigation during and after surgery in patients undergoing radical cystectomy with urinary diversion for bladder cancer. This pilot interventional study aims to increase the rate of urine sterilization and reduce urinary tract infections within 30 days after surgery by applying an antimicrobial irrigation solution called Irrisept4. Patients will receive irrigation with 50 7 25 ml of Irrisept4 during surgery for a contact time of 2 minutes on the bowel segment used for urinary diversion. After surgery, those with ileal conduits will have daily irrigation for about 10 days, while those with ileal neobladders will continue irrigation daily for about 21 days. This irrigation schedule corresponds to the typical time when stents and catheters are removed. Participants will be monitored through urine cultures taken around 30 days after surgery to assess sterilization and track symptomatic urinary tract infections. Other outcomes include measuring urine leaks, incidence of sepsis, and infection rates within the first month post-operation. The study will last throughout the irrigation period and includes follow-up assessments to evaluate infection and safety outcomes.
CONDITIONS
Brief Title
Chlorhexidine Antiseptic Irrigation of the Bowel Segment During Radical Cystectomy and Urinary Diversion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provision of signed and dated informed consent form
- Availability for the study duration and willingness to follow twice daily irrigation for 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 less than or equal to 1.5 mg/dL
You will not qualify if you...
- Previous or planned urinary diversion other than ileal conduit or neobladder
- Pregnancy or lactation
- Known allergy to chlorhexidine or components of the Irrisept system
- Uncontrolled illnesses including active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social conditions limiting study compliance
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo radical cystectomy with urinary diversion and receive Irrisept® Antimicrobial Wound Lavage irrigation of the bowel segment during surgery.
1 visit (in-person)
Duration - 10 ± 3 days for ileal conduit or 21 ± 7 days for ileal neobladder
Participants receive daily irrigation with Irrisept® Antimicrobial Wound Lavage of the ileal conduit for 10 ± 3 days or ileal neobladder for 21 ± 7 days, corresponding to the usual period until stent and catheter removal.
Daily irrigation visits during treatment period
Duration - Up to 30 ± 7 days post-surgery
Participants are monitored for incidence of urinary tract infection and urine culture status up to 30 ± 7 days after surgery.
Approximately 1 to 2 follow-up visits
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
S
Sagar Shah, BS
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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