RecruitingNot ApplicableNCT06689176

Chlorhexidine Antiseptic Irrigation of the Bowel Segment During Radical Cystectomy and Urinary Diversion

Chlorhexidine Antiseptic Irrigation of the Bowel Segment During Radical Cystectomy and Urinary Diversion After Chlorhexidine Irrigation in Patients Undergoing Radical Cystectomy


Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

23 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

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. 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether rinsing a portion of the bowel with chlorhexidine (a common antiseptic) during bladder removal surgery (radical cystectomy) reduces the risk of infection. When bladder cancer requires removing the bladder, surgeons use part of the bowel to create a new urinary tract — this antiseptic rinse may reduce bacteria-related complications afterward. **You may be eligible if...** - You are 18 or older - You have been diagnosed with bladder cancer - You are scheduled for radical cystectomy (bladder removal) with urinary diversion surgery - You have a good performance status (ECOG 0–2) and acceptable kidney function **You may NOT be eligible if...** - You have untreated or unstable medical conditions - Your kidney function is significantly impaired (creatinine above 1.5 mg/dL) - You are unable or unwilling to follow the post-operative irrigation instructions Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEIrrisept® 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.


Locations(1)

Mount Sinai Hospital

New York, New York, United States

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NCT06689176


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