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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
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.
Mount Sinai Hospital
New York, New York, United States
RECRUITINGNumber 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.
Time frame: 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.
Time frame: 30 ± 7 days post radical cystectomy with urinary diversion.
Percentage of urine leak from neobladder/ ileal conduit
Time frame: 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.
Time frame: 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.
Time frame: 30 ± 7 days post radical cystectomy with urinary diversion
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