Chlorhexidine-Impregnated Sponges and Less Frequent Dressing Changes for Prevention of Catheter-Related Infections in Critically Ill Adults A Randomized Controlled Trial
Chlorhexidine-Impregnated Sponges and Less Frequent Dressing Changes for Prevention of Catheter-Related Infections in Critically Ill Adults A Randomized Controlled Trial
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DOI：
10.1001/jama.2009.376
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发表时间：
2009-03-25
影响因子：
120.7
通讯作者：
Lucet, Jean-Christophe
中科院分区：
文献类型：
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作者：
Timsit, Jean-Francois;Schwebel, Carole;Lucet, Jean-Christophe
在血管内导管敷料中使用氯己定浸渍海绵（CHGIS）可减少导管相关感染（CRI）。每3天更换一次导管敷料的频率可能比必要的频率更高。目的评估CHGIS敷料在主要CRI发生率方面的优越性（临床脓毒症伴或不伴血流感染）和非劣效性设计、设置和患者评估者-盲法，2 × 2析因，2006年12月至2008年6月进行的随机对照试验，招募了来自法国3所大学和2所综合医院7个重症监护室的患者。患者为成年人（>18岁），预计需要动脉导管、中心静脉导管或两者均插入48小时或更长时间。每3天与每7天定期更换未污染的粘附敷料，立即更换任何污染或泄漏的敷料。主要结果测量主要CRI，用于比较CHGIS与对照敷料;定植率，用于比较3天与7天的敷料更换。结果在2095例符合条件的患者中，1636例（3778根导管，28931导管天）可以进行评价。导管插入的中位持续时间为6（四分位距[IQR]，4-10）天。干预措施之间没有相互作用。使用CHGIS敷料降低了重大CRI的发生率（10/1953 [0.5%]，0.6/1000导管-天vs 19/1825 [1.1%]，1.4/1000导管-天;风险比[HR]，0.39 [95%置信区间{CI}，0.17-0.93]; P= 0.03）和导管相关血流感染（6/1953导管，0.40/1000导管-天vs 17/1825导管，1.3/1000导管-天; HR，0.24 [95% CI，0.09-0.65]）。使用CHGIS敷料与导管取出时皮肤样本中细菌的耐药性无关。8例患者发生了重度CHGIS相关接触性皮炎（5.3/1000根导管）。使用CHGIS敷料防止了每117根导管发生1次重大CRI。导管定植率为142/1657根导管（7.8%）在3天组中（10.4/1000导管-天）和168/1828导管（8.6%）在7天组中（11.0/1000导管-天），平均绝对差异为0.8%（95% CI，-1.78%至2.15%）（HR，0.99; 95% CI，0.77-1.28），表明7天变化的非劣效性。3天组每根导管更换敷料的中位数为4次（IQR，3-6），7天组为3次（IQR，2-5）（P
Context Use of a chlorhexidine gluconate-impregnated sponge (CHGIS) in intravascular catheter dressings may reduce catheter-related infections (CRIs). Changing catheter dressings every 3 days may be more frequent than necessary.Objective To assess superiority of CHGIS dressings regarding the rate of major CRIs (clinical sepsis with or without bloodstream infection) and noninferiority (less than 3% colonization-rate increase) of 7-day vs 3-day dressing changes.Design, Setting, and Patients Assessor-blind, 2 x 2 factorial, randomized controlled trial conducted from December 2006 through June 2008 and recruiting patients from 7 intensive care units in 3 university and 2 general hospitals in France. Patients were adults (>18 years) expected to require an arterial catheter, central-vein catheter, or both inserted for 48 hours or longer.Interventions Use of CHGIS vs standard dressings (controls). Scheduled change of unsoiled adherent dressings every 3 vs every 7 days, with immediate change of any soiled or leaking dressings.Main Outcome Measures Major CRIs for comparison of CHGIS vs control dressings; colonization rate for comparison of 3-vs 7-day dressing changes.Results Of 2095 eligible patients, 1636 (3778 catheters, 28 931 catheter-days) could be evaluated. The median duration of catheter insertion was 6 (interquartile range [IQR], 4-10) days. There was no interaction between the interventions. Use of CHGIS dressings decreased the rates of major CRIs (10/1953 [0.5%], 0.6 per 1000 catheter-days vs 19/1825 [1.1%], 1.4 per 1000 catheter-days; hazard ratio [HR], 0.39 [95% confidence interval {CI}, 0.17-0.93]; P=.03) and catheter-related bloodstream infections (6/1953 catheters, 0.40 per 1000 catheter-days vs 17/1825 catheters, 1.3 per 1000 catheter-days; HR, 0.24 [95% CI, 0.09-0.65]). Use of CHGIS dressings was not associated with greater resistance of bacteria in skin samples at catheter removal. Severe CHGIS-associated contact dermatitis occurred in 8 patients (5.3 per 1000 catheters). Use of CHGIS dressings prevented 1 major CRI per 117 catheters. Catheter colonization rates were 142 of 1657 catheters (7.8%) in the 3-day group (10.4 per 1000 catheter-days) and 168 of 1828 catheters (8.6%) in the 7-day group (11.0 per 1000 catheter-days), a mean absolute difference of 0.8%(95% CI,-1.78% to 2.15%) (HR, 0.99; 95% CI, 0.77-1.28), indicating noninferiority of 7-day changes. The median number of dressing changes per catheter was 4(IQR, 3-6) in the 3-day group and 3 (IQR, 2-5) in the 7-day group (P