葡萄糖酸氯己定或聚六亚甲基双胍圆盘敷料减少中心静脉相关血流感染的发生率：一项可行性随机对照试验（CLABSI 试验）。

Chlorhexidine gluconate or polyhexamethylene biguanide disc dressing to reduce the incidence of central-line-associated bloodstream infection: a feasibility randomized controlled trial (the CLABSI trial).

机构信息

Royal Brisbane and Women's Hospital, Herston, Queensland, Australia; Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia; National Centre of Research Excellence in Nursing, Griffith University, Nathan, Queensland, Australia.

出版信息

J Hosp Infect. 2017 Jul;96(3):223-228. doi: 10.1016/j.jhin.2017.04.009. Epub 2017 Apr 16.

DOI:10.1016/j.jhin.2017.04.009

PMID:28526171

Abstract

BACKGROUND

A number of antimicrobial-impregnated discs to prevent central-line-associated bloodstream infection (CLABSI) are marketed but it is unclear which disc is most effective.

AIM

To investigate the feasibility and safety of comparing two antimicrobial-impregnated discs to prevent CLABSI.

METHODS

A single-centre, parallel group, randomized controlled trial was conducted in a 929-bed tertiary referral hospital. Hospital inpatients requiring a peripherally inserted central catheter were randomized to chlorhexidine gluconate (CHG) or polyhexamethylene biguanide (PHMB) disc dressing group. Dressings were replaced every seven days, or earlier, if clinically required. Participants were followed until device removal or hospital discharge. Feasibility outcomes included: proportion of potentially eligible participants who were enrolled; proportion of protocol violations; and proportion of patients lost to follow-up. Clinical outcomes were: CLABSI incidence, diagnosed by a blinded infection control practitioner; all-cause bloodstream infection (BSI); and product-related adverse events.

FINDINGS

Of 143 patients screened, 101 (71%) were eligible. Five (3.5%) declined participation. There was one post-randomization exclusion. Two (2%) protocol violations occurred in the CHG group. No patients were lost to follow-up. Three (3%) BSIs occurred; two (2%) were confirmed CLABSIs (one in each group) and one a mucosal barrier injury-related BSI. A total of 1217 device-days were studied, resulting in 1.64 CLABSIs per 1000 catheter-days. One (1%) disc-related adverse event occurred in the CHG group.

CONCLUSION

Disc dressings containing PHMB are safe to use for infection prevention at catheter insertion sites. An adequately powered trial to compare PHMB and CHG discs is feasible.

摘要

背景

有许多种抗菌浸渍盘可用于预防中心静脉导管相关性血流感染（CLABSI），但哪种盘最有效尚不清楚。

目的

调查比较两种抗菌浸渍盘预防 CLABSI 的可行性和安全性。

方法

在一家拥有 929 张床位的三级转诊医院进行了一项单中心、平行组、随机对照试验。需要外周插入中心导管的住院患者被随机分配到葡萄糖酸氯己定（CHG）或聚六亚甲基双胍（PHMB）盘敷贴组。如果临床需要，敷贴每 7 天或更早更换一次。参与者随访至导管拔出或出院。可行性结果包括：潜在合格参与者的纳入比例；方案违反比例；以及失访患者比例。临床结果为：通过盲法感染控制医生诊断的 CLABSI 发生率；所有原因的血流感染（BSI）；以及与产品相关的不良事件。

结果

在 143 名筛选患者中，有 101 名（71%）符合条件。5 名（3.5%）患者拒绝参与。随机分组后有 1 例排除。CHG 组发生 2 例（2%）方案违反。无患者失访。发生 3 例（3%）BSI；2 例（2%）为确诊 CLABSI（每组 1 例），1 例为黏膜屏障损伤相关 BSI。共研究了 1217 个设备日，每 1000 个导管日发生 1.64 例 CLABSI。CHG 组发生 1 例（1%）与敷贴相关的不良事件。