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临床试验/NCT02446158
NCT02446158已完成4 期

A Randomized Trial of Daily Chlorhexidine Care at the Exit Site in Peritoneal Dialysis Patients for Bacterial Decolonization and Prevention of Infection

E-DA Hospital0 个研究点目标入组 89 人开始时间: 2010年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
89
主要终点
exit site bacterial colonization status

研究概览

简要总结

Chlorhexidine is used in central line dressing changes and is effective in reducing line infections. It is unclear if daily chlorhexidine care at the exit site in peritoneal dialysis (PD) patients can reduce the risk of Staphylococcus aureus (SA) colonization or exit site infection.

详细描述

There is no consensus on what regimen is optimal for topical care of the peritoneal dialysis (PD) catheter exit site. Several methods including soap and water, povidone-iodine, hydrogen peroxide, chlorhexidine, and topical antimicrobial agents such as gentamicin or mupirocin cream have been described for care of the exit site. However, many of these studies were small or short-term and lacked longitudinal evaluation of bacterial decolonization efficacy. Staphylococcus aureus (SA) is one of most common causes of peritonitis and exit-site infection and is associated with a high PD catheter removal rate. Carriers of SA had a higher rate of exit-site infection than non-carriers. In previous studies, staphylococcal carriage prophylaxis using either mupirocin or gentimicin ointment in the nares or exit site significantly reduced the rate of exit-site infection due to SA. However, emerging antibiotic resistance is a concern. In addition, MRSA infection in PD patients is more severe than other pathogens; therefore, choosing a good antiseptic for SA and/or MRSA decolonization is important.

In recent years, the use of chlorhexidine in bathing or central line dressing changes was implemented to prevent bacterial colonization and multidrug resistant bacterial infections and was also used in hemodialysis patients. Data regarding chlorhexidine used in the catheter care of PD patients are limited and it is unclear if the use of chlorhexidine for exit site care contributes to long-term bacterial decolonization and acts as a prophylaxis for exit site infections.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients > 20 years old who received PD for more than 3 months

排除标准

  • a history of psychological illness or condition that interferes with caring of a wound
  • recent (within 1 month) exit-site infection, peritonitis, or tunnel infection
  • recent treatment with an antibiotic administered by any route in the last month
  • or known hypersensitivity to or intolerance of chlorhexidine or mupirocin

研究组 & 干预措施

Chlorhexidine gluconate

Experimental

PD (peritoneal dialysis) paitents with daily chlorhexidine exit site care

干预措施: Chlorhexidine gluconate (Drug)

结局指标

主要结局

exit site bacterial colonization status

时间窗: 1 year

We performed swab cultures at the exit site and nasal site every month during follow-up at the hospital and analyzed the bacterial colonization status at 6 and 12 months as the primary outcome.

次要结局

  • The exit-site infection rate(1 year)

研究者

发起方
E-DA Hospital
申办方类型
Other
责任方
Sponsor

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