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临床试验/NCT01919593
NCT01919593已完成4 期

The Efficacy of 2% Chlorhexidine Gluconate in 70% Alcohol Compared With 10% Povidone Iodine in Reducing Blood Culture Contamination in Pediatric Patients

Thammasat University1 个研究点 分布在 1 个国家目标入组 1,269 人开始时间: 2012年1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
入组人数
1,269
试验地点
1
主要终点
efficacy of 2% chlorhexidine gluconate in 70% alcohol compared with 10% povidone iodine

研究概览

简要总结

To evaluate the efficacy of 2% chlorhexidine gluconate in 70% alcohol compared with 10% povidone iodine in reducing blood culture contamination in pediatric patients.

详细描述

This is a prospective study of pediatric patients between 0-15 years of age who were admitted in three pediatric wards: general pediatric ward aged <5 years, general pediatric ward aged >5 years, and pediatric intensive care unit at a tertiary-care teaching hospital. Patients who needed percutaneous blood cultures were eligible for enrollment and were classified into two groups according to antiseptic used: 10% povidone iodine in odd months and 2% chlorhexidine gluconate in 70% alcohol in even months. Blood cultures were taken primarily by ward nurses using standard technique. The blood cultures were analysed and monitored for 5 days. Isolated organisms and their antimicrobial susceptibilities were determined using standard microbiologic techniques.

Blood culture isolates were categorized into two groups including a true pathogen and a contaminant by clinical criteria combined with laboratory data. A blood culture was classified as contaminated if common skin flora such as Coagulase negative staphylococci, Corynebacterium spp., Micrococcus spp., or Bacillus spp. were isolated from one of the blood culture samples without isolation of the same organism from another potential infection site (for example, intravenous catheter), or a common skin flora was isolated in a patient with incompatible clinical features and improved without specific treatment for that organism.

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
1 Day 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients between 0-15 years of age who were admitted in three pediatric wards: general pediatric ward aged <5 years, general pediatric ward aged >5 years, and pediatric intensive care unit. Patients who needed percutaneous blood cultures were eligible for enrollment.

排除标准

  • Preterm infant
  • Patient who had skin infection at site of venepuncture
  • Patient who had history allergy to 2% Chlorhexidine gluconate in 70% alcohol or 10% povidone-iodine

研究组 & 干预措施

2% Chlorhexidine Gluconate

Experimental

apply 2% Chlorhexidine Gluconate in 70% Alcohol on skin before venipuncture

干预措施: 2% chlorhexidine gluconate in 70% alcohol (Drug)

10% povidone iodine

Active Comparator

apply 10% povidone iodine on the skin before venipuncture

干预措施: 10%povidone iodine (Drug)

结局指标

主要结局

efficacy of 2% chlorhexidine gluconate in 70% alcohol compared with 10% povidone iodine

时间窗: 5 days

Pediatric patients who needed percutaneous blood cultures were recruited and were assigned 10% povidone iodine in odd months and 2% chlorhexidine gluconate in 70% alcohol in even months as an antiseptic for blood cultures. Blood culture isolates were categorized into two groups including a true pathogen and a contaminant by clinical criteria combined with laboratory data.

次要结局

  • safety of 2% chlorhexidine gluconate in 70% alcohol compared with 10% povidone iodine(48 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Auchara Tangsathapornpong

Associate Professor

Thammasat University

研究点 (1)

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