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一种用于预防中心静脉导管感染的可附着银浸渍袖带:一项前瞻性随机多中心试验。

An attachable silver-impregnated cuff for prevention of infection with central venous catheters: a prospective randomized multicenter trial.

作者信息

Maki D G, Cobb L, Garman J K, Shapiro J M, Ringer M, Helgerson R B

机构信息

Department of Medicine, University of Wisconsin Medical School, Madison.

出版信息

Am J Med. 1988 Sep;85(3):307-14. doi: 10.1016/0002-9343(88)90579-7.

Abstract

PURPOSE

Percutaneously inserted central venous catheters are widely used. Catheter-related bacteremia or fungemia is the most frequent serious complication of these catheters. In an attempt to reduce the frequency of such infections, a subcutaneous cuff constructed of a biodegradable collagen matrix impregnated with bactericidal silver was developed. Our goal was to assess, in a multicenter clinical trial, the effectiveness of this cuff in preventing catheter-related infection.

MATERIALS AND METHODS

Central venous catheters needed for fluid or drug therapy, hemodynamic monitoring, or hyperalimentation in patients in three centers were randomly assigned to be inserted with or without the cuff. Patients and catheters in the two groups were comparable in terms of risk factors predisposing to infection, including colonization of skin about the insertion site.

RESULTS

The results with 234 catheters inserted into a new site showed that catheters inserted with the cuff were threefold less likely to be colonized on removal (more than 15 colony-forming units) than were control catheters (28.9 percent versus 9.1 percent, p = 0.002) and were nearly fourfold less likely to produce bacteremia (3.7 percent versus 1.0 percent). Adverse effects from the cuff were not seen. The cuff did not confer protection, however against infection with catheters inserted over a guidewire into old sites. Most of the catheter-related infections identified in this study, including four of the six bacteremias, appear to have been caused by microorganisms colonizing skin about the insertion site, affirming the pathogenetic basis for benefit seen with the cuff in this clinical trial; two may have derived from contamination of the catheter hub.

CONCLUSION

This novel, silver-impregnated, attachable cuff can substantially reduce the incidence of catheter-related infection with most percutaneously inserted central venous catheters, can extend the time catheters can be left in place safely, and can prove cost-beneficial.

摘要

目的

经皮插入中心静脉导管应用广泛。导管相关菌血症或真菌血症是这些导管最常见的严重并发症。为降低此类感染的发生率,研发了一种由浸渍有杀菌银的可生物降解胶原基质构成的皮下袖套。我们的目标是在一项多中心临床试验中评估该袖套预防导管相关感染的有效性。

材料与方法

三个中心中需要进行液体或药物治疗、血流动力学监测或胃肠外营养的患者所使用的中心静脉导管被随机分配为带袖套插入或不带袖套插入。两组患者和导管在易发生感染的危险因素方面具有可比性,包括插管部位周围皮肤的定植情况。

结果

234根插入新部位的导管的结果显示,带袖套插入的导管在拔除时被定植(超过15个菌落形成单位)的可能性比对照导管小三倍(28.9%对9.1%,p = 0.002),发生菌血症的可能性小近四倍(3.7%对1.0%)。未观察到袖套的不良反应。然而,袖套对经导丝插入旧部位的导管感染并无保护作用。本研究中鉴定出的大多数导管相关感染,包括六例菌血症中的四例,似乎是由插管部位周围皮肤定植的微生物引起的,这证实了在该临床试验中袖套有益的发病机制基础;两例可能源于导管接头的污染。

结论

这种新型的、浸渍银的、可附着的袖套可显著降低大多数经皮插入中心静脉导管相关感染的发生率,可延长导管安全留置的时间,并可证明具有成本效益。

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