Lai Nai Ming, Lai Nai An, O'Riordan Elizabeth, Chaiyakunapruk Nathorn, Taylor Jacqueline E, Tan Kenneth
School of Medicine, Taylor's University, Subang Jaya, Malaysia.
Cochrane Database Syst Rev. 2016 Jul 13;7(7):CD010140. doi: 10.1002/14651858.CD010140.pub2.
The central venous catheter (CVC) is a device used for many functions, including monitoring haemodynamic indicators and administering intravenous medications, fluids, blood products and parenteral nutrition. However, as a foreign object, it is susceptible to colonisation by micro-organisms, which may lead to catheter-related blood stream infection (BSI) and in turn, increased mortality, morbidities and health care costs.
To assess the effects of skin antisepsis as part of CVC care for reducing catheter-related BSIs, catheter colonisation, and patient mortality and morbidities.
In May 2016 we searched: The Cochrane Wounds Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations and Epub Ahead of Print); Ovid EMBASE and EBSCO CINAHL Plus. We also searched clinical trial registries for ongoing and unpublished studies. There were no restrictions with respect to language, date of publication or study setting.
We included randomised controlled trials (RCTs) that assessed any type of skin antiseptic agent used either alone or in combination, compared with one or more other skin antiseptic agent(s), placebo or no skin antisepsis in patients with a CVC in place.
Two authors independently assessed the studies for their eligibility, extracted data and assessed risk of bias. We expressed our results in terms of risk ratio (RR), absolute risk reduction (ARR) and number need to treat for an additional beneficial outcome (NNTB) for dichotomous data, and mean difference (MD) for continuous data, with 95% confidence intervals (CIs).
Thirteen studies were eligible for inclusion, but only 12 studies contributed data, with a total of 3446 CVCs assessed. The total number of participants enrolled was unclear as some studies did not provide such information. The participants were mainly adults admitted to intensive care units, haematology oncology units or general wards. Most studies assessed skin antisepsis prior to insertion and regularly thereafter during the in-dwelling period of the CVC, ranging from every 24 h to every 72 h. The methodological quality of the included studies was mixed due to wide variation in their risk of bias. Most trials did not adequately blind the participants or personnel, and four of the 12 studies had a high risk of bias for incomplete outcome data.Three studies compared different antisepsis regimens with no antisepsis. There was no clear evidence of a difference in all outcomes examined, including catheter-related BSI, septicaemia, catheter colonisation and number of patients who required systemic antibiotics for any of the three comparisons involving three different antisepsis regimens (aqueous povidone-iodine, aqueous chlorhexidine and alcohol compared with no skin antisepsis). However, there were great uncertainties in all estimates due to underpowered analyses and the overall very low quality of evidence presented.There were multiple head-to-head comparisons between different skin antiseptic agents, with different combinations of active substance and base solutions. The most frequent comparison was chlorhexidine solution versus povidone-iodine solution (any base). There was very low quality evidence (downgraded for risk of bias and imprecision) that chlorhexidine may reduce catheter-related BSI compared with povidone-iodine (RR of 0.64, 95% CI 0.41 to 0.99; ARR 2.30%, 95% CI 0.06 to 3.70%). This evidence came from four studies involving 1436 catheters. None of the individual subgroup comparisons of aqueous chlorhexidine versus aqueous povidone-iodine, alcoholic chlorhexidine versus aqueous povidone-iodine and alcoholic chlorhexidine versus alcoholic povidone-iodine showed clear differences for catheter-related BSI or mortality (and were generally underpowered). Mortality was only reported in a single study.There was very low quality evidence that skin antisepsis with chlorhexidine may also reduce catheter colonisation relative to povidone-iodine (RR of 0.68, 95% CI 0.56 to 0.84; ARR 8%, 95% CI 3% to 12%; ; five studies, 1533 catheters, downgraded for risk of bias, indirectness and inconsistency).Evaluations of other skin antiseptic agents were generally in single, small studies, many of which did not report the primary outcome of catheter-related BSI. Trials also poorly reported other outcomes, such as skin infections and adverse events.
AUTHORS' CONCLUSIONS: It is not clear whether cleaning the skin around CVC insertion sites with antiseptic reduces catheter related blood stream infection compared with no skin cleansing. Skin cleansing with chlorhexidine solution may reduce rates of CRBSI and catheter colonisation compared with cleaning with povidone iodine. These results are based on very low quality evidence, which means the true effects may be very different. Moreover these results may be influenced by the nature of the antiseptic solution (i.e. aqueous or alcohol-based). Further RCTs are needed to assess the effectiveness and safety of different skin antisepsis regimens in CVC care; these should measure and report critical clinical outcomes such as sepsis, catheter-related BSI and mortality.
中心静脉导管(CVC)是一种用于多种功能的装置,包括监测血流动力学指标以及给予静脉内药物、液体、血液制品和肠外营养。然而,作为一种异物,它易被微生物定植,这可能导致导管相关血流感染(BSI),进而增加死亡率、发病率和医疗保健成本。
评估作为CVC护理一部分的皮肤消毒对降低导管相关BSI、导管定植以及患者死亡率和发病率的效果。
2016年5月,我们检索了:Cochrane伤口专业注册库;Cochrane对照试验中心注册库(CENTRAL)(Cochrane图书馆);Ovid MEDLINE(包括在研及其他未索引的引用文献和印刷前的电子版);Ovid EMBASE和EBSCO CINAHL Plus。我们还检索了临床试验注册库以查找正在进行和未发表的研究。对语言、出版日期或研究背景没有限制。
我们纳入了评估单独使用或联合使用的任何类型皮肤消毒剂的随机对照试验(RCT),并将其与一种或多种其他皮肤消毒剂、安慰剂或未进行皮肤消毒的情况进行比较,这些试验的对象为已置入CVC的患者。
两位作者独立评估研究的纳入资格、提取数据并评估偏倚风险。对于二分法数据,我们以风险比(RR)、绝对风险降低率(ARR)和为获得额外有益结果所需治疗的人数(NNTB)来表示结果;对于连续数据,以均数差(MD)表示结果,并给出95%置信区间(CI)。
13项研究符合纳入标准,但只有12项研究提供了数据,共评估了3446根CVC。由于一些研究未提供此类信息,因此纳入研究的参与者总数尚不清楚。参与者主要是入住重症监护病房、血液肿瘤病房或普通病房的成年人。大多数研究在CVC插入前评估皮肤消毒情况,并在此后CVC留置期间定期进行评估,时间间隔从每24小时至每72小时不等。由于纳入研究的偏倚风险差异很大,其方法学质量参差不齐。大多数试验未对参与者或人员进行充分的盲法处理,12项研究中有4项因结局数据不完整而存在较高的偏倚风险。三项研究将不同的消毒方案与未消毒进行了比较。在所有检查的结局中,包括导管相关BSI、败血症、导管定植以及在涉及三种不同消毒方案(水性聚维酮碘、水性氯己定和酒精与未进行皮肤消毒)的任何一项比较中需要全身性抗生素治疗的患者人数,均未发现明显差异。然而,由于分析效能不足以及所呈现证据的总体质量非常低,所有估计值都存在很大的不确定性。不同皮肤消毒剂之间进行了多次直接比较,活性物质和基础溶液有不同的组合。最常见的比较是氯己定溶液与聚维酮碘溶液(任何基础溶液)。有非常低质量的证据(因偏倚风险和不精确性而降级)表明,与聚维酮碘相比,氯己定可能降低导管相关BSI(RR为0.64,95%CI为0.41至0.99;ARR为2.30%,95%CI为0.06至3.70%)。该证据来自四项涉及1436根导管的研究。水性氯己定与水性聚维酮碘、酒精性氯己定与水性聚维酮碘以及酒精性氯己定与酒精性聚维酮碘的个体亚组比较中,均未显示出导管相关BSI或死亡率有明显差异(且通常分析效能不足)。仅在一项研究中报告了死亡率。有非常低质量的证据表明,与聚维酮碘相比,用氯己定进行皮肤消毒也可能减少导管定植(RR为0.68,95%CI为0.56至0.84;ARR为8%,95%CI为3%至12%;五项研究,1533根导管,因偏倚风险、间接性和不一致性而降级)。对其他皮肤消毒剂的评估通常在单个小型研究中进行,其中许多研究未报告导管相关BSI的主要结局。试验对其他结局(如皮肤感染和不良事件)的报告也很差。
与未进行皮肤清洁相比,用消毒剂清洁CVC插入部位周围的皮肤是否能降低导管相关血流感染尚不清楚。与用聚维酮碘清洁相比,用氯己定溶液进行皮肤清洁可能降低CRBSI和导管定植率。这些结果基于非常低质量的证据,这意味着真实效果可能有很大差异。此外,这些结果可能受消毒溶液的性质(即水性或酒精性)影响。需要进一步的RCT来评估不同皮肤消毒方案在CVC护理中的有效性和安全性;这些研究应测量和报告关键的临床结局,如败血症、导管相关BSI和死亡率。