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Antiseptic

Chlorhexidine Irrigation for Bladder Cancer

N/A
Recruiting
Led By John P Sfakianos, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed diagnosis of bladder cancer
Candidate for radical cystectomy with urinary diversion
Must not have
Has undergone or planned to undergo urinary diversion other than ileal conduit or neobladder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 ± 7 days post radical cystectomy with urinary diversion
Awards & highlights
No Placebo-Only Group

Summary

This trial involves testing the use of chlorhexidine irrigation during and after surgery in patients having their bladder removed. They will irrigate the surgical area during the operation and then use a solution called Irrise

Who is the study for?
This trial is for patients undergoing radical cystectomy with urinary diversion due to bladder cancer. Participants must be suitable for surgery and willing to have their surgical site irrigated with a chlorhexidine solution both during and after the procedure.
What is being tested?
The study tests the effectiveness of Irrisept® (a chlorhexidine-based antimicrobial wound lavage) in sterilizing urine and reducing urinary tract infections when used during and after bladder surgery.
What are the potential side effects?
Potential side effects may include irritation or allergic reactions at the irrigation site, changes in skin flora, or resistance development. Specific side effects will depend on individual patient sensitivity to chlorhexidine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with bladder cancer.
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I am a candidate for major bladder surgery with a new way for urine to exit my body.
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I can take care of myself and am up and about more than half of the day.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had or will have surgery to redirect urine flow not using ileal conduit or neobladder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 ± 7 days post radical cystectomy with urinary diversion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 ± 7 days post radical cystectomy with urinary diversion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants that have negative urine culture
Proportion of participants with incident symptomatic UTI
Secondary study objectives
Percentage of patients with sepsis
Percentage of symptomatic urinary tract infections

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients undergoing radical cystectomy with urinary diversionExperimental Treatment1 Intervention
Patients undergoing radical cystectomy and ileal conduit or ileal neobladder will receive Irrisept ® Antimicrobial Wound Lavage as intervention

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
904 Previous Clinical Trials
541,765 Total Patients Enrolled
Irrimax CorporationIndustry Sponsor
10 Previous Clinical Trials
2,077 Total Patients Enrolled
John P Sfakianos, MDPrincipal InvestigatorAssociate Professor of Urology
~27 spots leftby Aug 2025
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