General and Specialized Nursing Department, Ribeirão Preto College of Nursing, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.
Department of Rehabilitation Medicine, School of Medicine, University of Washington, Seattle, WA, USA.
Aust Crit Care. 2019 Nov;32(6):471-478. doi: 10.1016/j.aucc.2018.11.001. Epub 2018 Dec 15.
In patients with short-term percutaneous central venous catheter (CVC), it is recommended that a dressing be applied to the catheter insertion site to prevent catheter-related infections.
The objective of this study was to assess the feasibility of a randomised controlled trial to compare the efficacy of chlorhexidine-impregnated dressing with that of polyurethane dressing in the prevention of catheter-related infections in critically ill adult patients with short-term percutaneous CVC.
One hundred fifteen patients with a CVC were randomised to chlorhexidine-impregnated gel dressing (chlorhexidine gel group) or transparent polyurethane dressing (polyurethane group) between April and December 2014. Feasibility outcomes included data on eligibility, recruitment, missing data, and protocol violation. The primary outcome measure of efficacy was the presence of colonisation with the same microorganism in both the skin swab around catheter insertion site and the catheter tip.
Of 526 patients assessed for eligibility, 411 (78%) did not meet inclusion criteria, and 115 (22%) were randomised. Among participants of both groups, there were 14 missing primary outcomes of which 10 were due to failure to collect the catheter tip (a protocol violation). The final sample had 47 and 54 individuals in the chlorhexidine and polyurethane groups, respectively. Skin and catheter tip were colonised by the same microorganism for 13% of the participants in the chlorhexidine group and 8% in the polyurethane group, although the difference was not statistically significant (p = 0.51). There were no differences between the two groups for catheter tip colonisation, skin site colonisation, catheter insertion site infection, catheter-related bloodstream infection, skin irritation, and the number of unplanned dressing changes.
Our preliminary results found that a large randomised controlled trial would be feasible. This study provides valuable information that can be used to design more robust studies to prevent infection among patients with short-term percutaneous CVC when using either chlorhexidine or polyurethane dressing.
在短期经皮中心静脉导管（CVC）患者中，建议在导管插入部位应用敷料，以预防导管相关性感染。
本研究旨在评估一项随机对照试验的可行性，以比较氯己定浸渍敷料与聚氨酯敷料在预防短期经皮 CVC 的危重症成年患者导管相关性感染方面的疗效。
2014 年 4 月至 12 月期间，将 115 例 CVC 患者随机分为氯己定凝胶敷料（氯己定凝胶组）或透明聚氨酯敷料（聚氨酯组）。可行性结局包括合格性、招募、缺失数据和违反方案的数据。疗效的主要结局测量指标是导管插入部位周围皮肤拭子和导管尖端存在相同微生物定植。
在评估合格性的 526 例患者中，有 411 例（78%）不符合纳入标准，115 例（22%）被随机分组。两组参与者中，有 14 例主要结局缺失，其中 10 例是由于未能采集导管尖端（违反方案）。最终样本中，氯己定组和聚氨酯组分别有 47 例和 54 例。氯己定组有 13%的参与者皮肤和导管尖端被同一微生物定植，聚氨酯组有 8%，但差异无统计学意义（p=0.51）。两组间导管尖端定植、皮肤部位定植、导管插入部位感染、导管相关血流感染、皮肤刺激和计划外更换敷料的次数均无差异。
我们的初步结果发现，大型随机对照试验是可行的。本研究提供了有价值的信息，可用于设计更稳健的研究，以预防短期经皮 CVC 患者使用氯己定或聚氨酯敷料时发生感染。
