Chlorhexidine Antiseptic Irrigation of the Bowel Segment During Radical Cystectomy and Urinary Diversion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Irrisept® Antimicrobial Wound Lavage.
- Who it may be relevant to
- Registry conditions: Bladder Cancer, Urinary Tract Infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Chlorhexidine Antiseptic Irrigation of the Bowel Segment During Radical Cystectomy and Urinary Diversion After Chlorhexidine Irrigation in Patients Undergoing Radical Cystectomy
Overview
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.
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.
Interventions
- Device Irrisept® Antimicrobial Wound Lavage
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.
Primary outcome measures
- Number of participants that have negative urine culture [Time frame: 30 ± 7 days post radical cystectomy with urinary diversion.]
- Proportion of participants with incident symptomatic UTI [Time frame: 30 ± 7 days post radical cystectomy with urinary diversion.]
Secondary outcome measures (3)
- Percentage of urine leak from neobladder/ ileal conduit [Time frame: 30 ± 7 days post radical cystectomy with urinary diversion]
- Percentage of patients with sepsis [Time frame: 30 ± 7 days post radical cystectomy with urinary diversion]
- Percentage of symptomatic urinary tract infections [Time frame: 30 ± 7 days post radical cystectomy with urinary diversion]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mount Sinai Hospital — New York
Identifiers
NCT: NCT06689176 · STUDY-23-00340