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| Name | Class |
|---|---|
| Irrimax Corporation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irrisept® Antimicrobial Wound Lavage | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 30 ± 7 days post radical cystectomy with urinary diversion. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of urine leak from neobladder/ ileal conduit | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Monali Fatterpekar, PhD | Contact | (212) 241-0751 | monali.fatterpekar@mountsinai.org | |
| Sagar Shah, BS | Contact | (212) 241-0751 | sagar.shah@mountsinai.org |
| Name | Affiliation | Role |
|---|---|---|
| John P Sfakianos, MD | Associate Professor of Urology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | Recruiting | New York | New York | 10029 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Immediately following publication. No end date.
Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose. Any purpose. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (TBD).
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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.
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| 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. | 30 ± 7 days post radical cystectomy with urinary diversion |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D007239 | Infections |