NCT04152720Unknown不适用
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
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- 1) Incidence of catheter-associated urinary tract infection (CAUTI) * 2 weeks after urethral catheterization
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 19 and 80 years old
- •Persons requiring urethral catheterization for more than 2 weeks after surgery * due to urological diseases
- •* Radical cystectomy
- •Subjects who voluntarily decided to participate and signed the written informed consent
- •A person who can understand and follow the instructions and participate in the pre-clinical period.
排除标准
- •A person with a congenital abnormality in the urinary or reproductive system
- •Immunodeficiency disease (eg HIV infected)
- •Urinary tract fistula
- •Allergic history of the material used in the catheter
- •Symptomatic UTI by baseline time point
- •Dermatitis at the catheter insertion site
- •Pregnant or lactating women
- •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.
- •Inappropriate participation in the study, as determined by the investigator or investigator, as it may affect ethical or clinical trial results.
- •Patients on anti-thrombotic medication (excluding low-dose aspirin (100 mg, up to 300 mg / day))
结局指标
主要结局
1) Incidence of catheter-associated urinary tract infection (CAUTI) * 2 weeks after urethral catheterization
时间窗: 2 weeks
次要结局
- 4) Catheter-associated urinary tract infection 2 weeks after urethral catheter insertion in test and control groups(2 weeks)
- 2) Incidence of Significant Bacterial Cultures in Urethral Catheter Tip Culture(2 weeks)
- 5) Antibiotic administration period due to catheter-related urinary tract infection(2 weeks)
- 3) Catheter related complication rate(2 weeks)
- 1) Period until catheter-associated urinary tract infection (CAUTI) occurs(2 weeks)
研究者
Ja Hyeon Ku
Professor
Seoul National University Hospital
研究点 (2)
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