Prevention of Nosocomial Escherichia Coli Infections After Placement of an Indwelling Catheter During Pelvic Surgery: a Randomized, Prospective, Double Blind Study for the Evaluation of Cranberry (Vaccinium Macrocarpon) Gel Capsules
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- Presence/absence of Asymptomatic bacteriuria
研究概览
简要总结
Indwelling urinary catheters are a primary site for nosocomial infections. The purpose of this study is to evaluate the anti-adhesive properties of Cranberry type A pro anthocyanidine gel capsules in the prevention Escherichia coli infections on indwelling urinary catheters placed in patients following pelvic surgery. The investigators primary working hypothesis is that cranberry treatment decreases E. coli colonization on indwelling urinary catheters, thus preventing nosocomial urinary infections following pelvic surgery.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is cared for by the department of the Gynecology at the Nîmes Unversity Hospital
- •The patient is programmed for surgery with placement an indwelling catheter for 48 hours with a sterile urinary cytobacteriologic exam at inclusion
排除标准
- •the urinary cytobacteriologic exam at inclusion is positive
- •the patient is taking antivitamin K
- •the patient is taking antibiotics
- •history of urolithiasis
- •the patient refuses to participate
- •the patient is pregnant or nursing
- •the patient is not associated with a social security system (no insurance)
- •the patient is under guardianship
结局指标
主要结局
Presence/absence of Asymptomatic bacteriuria
时间窗: 15 days post-op
Presence/absence of greater than 10\^5 unit forming E. coli colonies per ml of urine with absence of functional urinary infection symptoms (mictional burning, pollakiuria, dysuria, urgency, suprapubic heaviness)
次要结局
未报告次要终点