Bladder CancerNCT06689176
Chlorhexidine Antiseptic Irrigation of the Bowel Segment During Radical Cystectomy and Urinary Diversion
A study testing Irrisept® Antimicrobial Wound Lavage in people with Bladder Cancer and Urinary Tract Infection, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Urinary Tract Infection
- What is being tested?
- Irrisept® Antimicrobial Wound Lavage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 1 Jul 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mount Sinai Hospital
New York, New York, 10029
John Sfakianos, MD, John.Sfakianos@mountsinai.org
John Sfakianos, MD
About this study
Official title: Chlorhexidine Antiseptic Irrigation of the Bowel Segment During Radical Cystectomy and Urinary Diversion After Chlorhexidine Irrigation in Patients Undergoing Radical Cystectomy
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.
Read the detailed description
Th research team proposes to increase the rate of sterilization of urine from patients with urinary diversion and reduce the incidence of UTI up to 30 ± 7 days post radical cystectomy and urinary diversion using 50 ± 25ml of Irrisept ® irrigation solution lavage of the bowel segment during surgery for a contact time of 2 minutes. For patients who obtain an ileal conduits irrigation using 50 ± 25ml of Irrisept ® will be performed daily for 10 days +/- 3 days and for those patients obtaining ileal neobladders irrigation using 50 ± 25ml of Irrisept ® will continue for 21 days +/- 7 days. The irrigation will continue for the given time described above as this is usually when stents and catheters are removed.
- Conditions
- Bladder Cancer, Urinary Tract Infection
- Being tested
- Irrisept® Antimicrobial Wound Lavage
- Keywords
- Bladder Cancer, Radical Cystectomy, Ileal Conduit, Neobladder, Chlorhexidine Gluconate, Irrisept
- Medical subject headings
- Urinary Bladder Neoplasms, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irrisept® Antimicrobial Wound LavageDevice
Irrisept® Antimicrobial Wound Lavage is a single-use, manual, self-contained irrigation device comprised of a 450mL bottle of 0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation, United States Pharmacopeia (USP) and an applicator (labeled Irriprobe®). The solution is aseptically filled in a Blow-Fill-Seal (BFS) bottle. The CHG acts as a preservative to inhibit microbial growth in the solution.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing radical cystectomy with urinary diversion | Experimental | Patients undergoing radical cystectomy and ileal conduit or ileal neobladder will receive Irrisept ® Antimicrobial Wound Lavage as intervention Receives: Device: Irrisept® Antimicrobial Wound Lavage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that have negative urine culture
Negative urine culture will be defined as a colony count of less than or equal to 100000 CFU/ml. The urine sample will be collected by catheterization of the conduit with a 16F Foley catheter, which provides the least number of CFU of bacteria compared to collection from the ostomy bag. Patients with ileal neobladder will give a spontaneously voided urine sample when able or will be obtained from catheterized urine for those who cannot void.
Measured: 30 ± 7 days post radical cystectomy with urinary diversion.
Proportion of participants with incident symptomatic UTI
Proportion of participants with incident symptomatic UTI by 30 ± 7 days post radical cystectomy with urinary diversion. Symptomatic UTI will be defined as a positive urine culture in the presence of fever (≥38°C) with or without associated flank/abdominal pain.
Measured: 30 ± 7 days post radical cystectomy with urinary diversion.
Secondary outcomes (3)
Percentage of urine leak from neobladder/ ileal conduit
Measured: 30 ± 7 days post radical cystectomy with urinary diversion
Percentage of patients with sepsis
Percentage of patients with sepsis (when the body reacts to an infection) will be assessed. In case >/= 10% of participants experience sepsis, the intervention will be considered unacceptable.
Measured: 30 ± 7 days post radical cystectomy with urinary diversion
Percentage of symptomatic urinary tract infections
Symptomatic urinary tract infection is when a person has positive UTI and has fever and other symptoms including pain when passing urine and pain in the lower belly.
Measured: 30 ± 7 days post radical cystectomy with urinary diversion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start1 Aug 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is single center, open-label study where the participants will be identified from the principal investigator and sub-investigator's clinic. All the participants who meet the study criteria and sign the consent form will be assigned to the study intervention.
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Irrimax Corporation
- Responsible party
- Principal investigator, John Sfakianos, Icahn School of Medicine at Mount Sinai
- Investigators
- John P Sfakianos, MD, Principal investigator, Associate Professor of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689176
- Sponsor's protocol ID
- STUDY-23-00340
- Status last verified
- Dec 2025
- First submitted
- 12 Nov 2024
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).