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临床试验/NCT03101371
NCT03101371
已完成
2 期

Reducing Urinary Tract Infection Rates Using a Controlled Aseptic Protocol for Catheter Insertion

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 99 人2017年10月10日

概览

阶段
2 期
干预措施
Standard of care catheter insertion
疾病 / 适应症
Urinary Tract Infections
发起方
University of Colorado, Denver
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)
状态
已完成
最后更新
6年前

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.

注册库
clinicaltrials.gov
开始日期
2017年10月10日
结束日期
2019年2月15日
最后更新
6年前
研究类型
Interventional
研究设计
Parallel
性别
Female

研究者

责任方
Sponsor

入排标准

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

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

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)

研究点 (1)

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