Clinical trial NCT04152720: Evaluate the Efficacy and Safety of Prevention of Infection Foley Catheter as Compared to Conventional Foley Catheter
Official title: A Randomized, Multi-center, Open, Active-controlled Prospective Design Pilot Clinical Study to Evaluate the Efficacy and Safety of Prevention of Infection Foley Catheter as Compared to Conventional Foley Catheter in Patient Who Underwent Radical Cystectomy for Urological Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urological Disease
Radical Cystectomy
Keywords: CAUTI
Catheter-associated urinary tract infection
Prevention of infection Foley Catheter
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
name: Samsung Medical Center
First posted: 2019-11-05
Enrollment: 160
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Comparison of effectiveness and safety of infection prevention silicone urinary catheters and conventional catheters for patients scheduled to perform urinary catheterization after radical cystectomy for urological diseases for more than 2 weeks Want to prove the clinical efficacy and safety.


Eligibility criteria: Inclusion Criteria:

1. Between 19 and 80 years old
2. Persons requiring urethral catheterization for more than 2 weeks after surgery \* due to urological diseases

   \* Radical cystectomy
3. Subjects who voluntarily decided to participate and signed the written informed consent
4. A person who can understand and follow the instructions and participate in the pre-clinical period.

Exclusion Criteria:

1. A person with a congenital abnormality in the urinary or reproductive system
2. Immunodeficiency disease (eg HIV infected)
3. Urinary tract fistula
4. Allergic history of the material used in the catheter
5. Symptomatic UTI by baseline time point
6. Dermatitis at the catheter insertion site
7. Pregnant or lactating women
8. A person who does not agree to contraceptive \* in a medically accepted manner until the end of the study and 4 weeks after the end of the study.

   Medically acceptable contraceptive methods: condoms, oral contraceptives lasting at least 12 weeks, injectable or injectable contraceptives, intrauterine contraceptives, etc.
9. Inappropriate participation in the study, as determined by the investigator or investigator, as it may affect ethical or clinical trial results.
10. Patients on anti-thrombotic medication (excluding low-dose aspirin (100 mg, up to 300 mg / day))

Primary outcomes:
measure: 1) Incidence of catheter-associated urinary tract infection (CAUTI) * 2 weeks after urethral catheterization
timeFrame: 2 weeks
Secondary outcomes:
measure: 1) Period until catheter-associated urinary tract infection (CAUTI) occurs
timeFrame: 2 weeks
measure: 2) Incidence of Significant Bacterial Cultures in Urethral Catheter Tip Culture
timeFrame: 2 weeks
measure: 3) Catheter related complication rate
timeFrame: 2 weeks
measure: 4) Catheter-associated urinary tract infection 2 weeks after urethral catheter insertion in test and control groups
timeFrame: 2 weeks
measure: 5) Antibiotic administration period due to catheter-related urinary tract infection
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: