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临床试验/NCT01359046
NCT01359046已完成不适用

Randomized Control Trial of Silver-alloy Impregnated Suprapubic Catheters in Urogynecology Patients

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 288 人开始时间: 2011年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
288
试验地点
2
主要终点
Urinary Tract Infection Rate

研究概览

简要总结

The purpose of this study is to compare urinary tract infection rates among women undergoing urogynecological procedures with a silver-alloy suprapubic catheter compared to the standard suprapubic catheter.

详细描述

Urinary catheters are used routinely in the postoperative care of urogynecology patients after surgery involving the genitourinary tract. However, Urinary tract infections(UTI) associated with indwelling catheter is the second leading cause of nosocomial infections. 20% of hospital acquired bacteremia arise from UTI with an associated mortality of 10%.

There are many different types of catheters available for use. Standard indwelling catheters are made from a variety of materials including polyvinyl chlorine, plastic, plain latex, polytetrafluoroethylene, silicone elastomer, pure silicone hydrogel and polymer hydromer. Specialized catheters have been developed with the aim of reducing infection. Strategies generally involved coating the inner, outer or both surfaces of the catheter with antimicrobial materials. These materials can be antibiotic or antiseptic with the most common antiseptic material used being silver. Silver ions are bactericidal, are used safely when applied topically to humans and used in controlling infections.

Previous studies comparing UTI rates in transurethral catheters have reported a significant reduction of UTI rate in silver-alloy catheters with a range of 5-12% compared to standard catheters with a range of 7-50%. There are no studies comparing the UTI rate in silver-alloy supra-pubic catheters to standard supra-pubic catheters. The investigators hypothesize that this study will show a statistically significant decrease in UTI rate among the individuals with a silver-alloy suprapubic catheter compared to the standard silver-alloy catheter.

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, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • patients requiring intra-operative placement of suprapubic catheters as part of routine post-operative care for repair of vaginal anterior compartment prolapse i.e. patients undergoing anterior colporrhaphy, Burch colposuspension, with or without mid-urethral sling

排除标准

  • Known UTI at time of surgery
  • Unable to provide informed consent
  • Use of chronic intermittent self-catheterization pre-operatively
  • Use of chronic prophylactic antibiotics
  • Use of antibiotics for any indication other than UTI during peri-operative and 6-week post-operative period
  • Presence of fistula involving urogenital tract
  • Use of chronic steroids or immunosuppressant
  • Immunocompromised patient

研究组 & 干预措施

silver SPC

Experimental

Subjects randomized to receive silver-impregnated SPC.

干预措施: silver SPC (Device)

standard SPC

Active Comparator

subjects randomized to receive standard SPC.

干预措施: standard SPC (Device)

结局指标

主要结局

Urinary Tract Infection Rate

时间窗: within 6 weeks post surgery

Number of subjects diagnosed with a urinary tract infection (UTI) within 6 weeks of surgery. A UTI is defined as any symptoms requiring antibiotic treatment, a urine culture with \>10\^5 cfu/mL, or a urine culture with \>10\^3 cfu/mL and evidence of pyuria.

次要结局

  • Risk of Urinary Tract Infections in Diabetics(within 6 weeks post surgery)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

John B. Gebhart

PI

Mayo Clinic

研究点 (2)

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