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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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

Locations
United States
New York
Mount Sinai Hospital
RECRUITING
New York
Contact Information
Primary
Monali Fatterpekar, PhD
monali.fatterpekar@mountsinai.org
(212) 241-0751
Backup
Sagar Shah, BS
sagar.shah@mountsinai.org
(212) 241-0751
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2025-08-01
Participants
Target number of participants: 40
Treatments
Experimental: Patients undergoing radical cystectomy with urinary diversion
Patients undergoing radical cystectomy and ileal conduit or ileal neobladder will receive Irrisept ® Antimicrobial Wound Lavage as intervention
Sponsors
Collaborators: Irrimax Corporation
Leads: Icahn School of Medicine at Mount Sinai

This content was sourced from clinicaltrials.gov