Reducing Urinary Tract Infection Rates Using a Controlled Aseptic Protocol for Catheter Insertion
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Number of Participants With a Catheter Associated Urinary Tract Infection (CAUTI)
研究概览
简要总结
Urinary Tract Infection (UTI) complications following catheter use in surgical patients remains high. Using an aseptic protocol has been shown to drastically reduce UTI incidence by 50%. Reducing UTIs will prevent extended hospital stays, readmission, and antibiotic use associated with this complication and improve cost-effectiveness of care. The investigators hypothesize that they can reduce the incidence of UTIs after catheter placement with the implementation of a Quality Improvement (QI) protocol to prevent excess exposure to the environment exposure of the catheter before, during and after insertion.
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
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women 18-89 years of age
- •admitted for surgery lasting >1 hour and requiring urinary catheter,
- •have normal urine analysis within 24 hours pre-surgery, and
- •able to provide informed consent.
排除标准
- •currently on dialysis,
- •chronic urinary infection,
- •hyperthyroidism,
- •current infection,
- •a history of allergy or sensitivity to iodine.
- •women who are pregnant or breast feeding
- •men due to their lower incidence of UTIs compared to the female population.
研究组 & 干预措施
Standard of care catheter insertion
Standard of care catheter insertion in which catheter is inserted right out of package/non-treated catheter.
干预措施: Standard of care catheter insertion (Procedure)
Aseptic protocol for catheter insertion
Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter
干预措施: Catheter insertion with Povidone Iodine (Drug)
结局指标
主要结局
Number of Participants With a Catheter Associated Urinary Tract Infection (CAUTI)
时间窗: Within 14 +/- 2 days post-surgery
Participants were monitored for up to 14 days. This was assessed with a rapid urine analysis (UA) test. A urinary tract infection was defined as \>10\^5 bacterial colony forming units per ML on urine culture regardless of symptoms. This is the number of participants who had at least one CAUTI during the time of observation.
次要结局
- Number of Participants That Were Readmitted, Had Additional Clinic Visits or Went to the Emergency Department (ED) for Any Reason(Day 14 (+/- 2 days))
- Average Patient Satisfaction(Day14 (+/- 2 days))
- Number of Participants With Extended Hospital Stay Due to a Urinary Tract Infection (UTI)(14 days (+/- 2 days) from surgery)
- Number of Patients That Used Antibiotics at the Time of Surgery and Post-surgery(Day 14 (+/- 2 days))
- Number of Participants Who Received the "Fill and Pull" Versus the "Pull and Void" Method of Catheter Discontinuation(Day 14 (+/- 2 days))
- Number of Participants With Closed Drainage System Disrupted During Placement of Catheter(Day 1 post op)