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Sterile versus non-sterile gloves for traumatic wounds in the ED
Emergency Medicine Journal ( IF 3.1 ) Pub Date : 2022-09-01 , DOI: 10.1136/emermed-2022-212517
David Metcalfe 1, 2 , Nick R Parsons 2 , Matthew L Costa 3
Affiliation  

In their Emergency Medicine Journal paper, Zwaans et al present a randomised controlled trial that asked whether the use of non-sterile gloves and dressings affects risk of infection when suturing traumatic wounds in the ED.1 Most randomised trials compare two treatments so they can determine which is better. However, such a ‘superiority’ design would not make sense when comparing the effect of sterile and non-sterile gloves as there is no reason to think that non-sterile gloves should be superior in terms of reducing wound infections. There may nevertheless be other reasons to prefer non-sterile gloves if they are ‘not much worse’—perhaps because they are cheaper, more accessible or generate less packaging waste. Zwaans et al therefore chose a non-inferiority trial design. Instead of asking whether sterile or non-sterile gloves are ‘better’, their trial asked whether non-sterile gloves are ‘much worse’ than sterile equivalents. To answer such a question, Zwaans et al first had to specify ‘how much worse’ they would be willing to accept. This ‘non-inferiority margin’ is a matter of judgement and depends on factors such as the downsides of sterile gloves (eg, cost, accessibility and environmental burden) and the magnitude of the risk they seek to avoid (eg, wound infection). The trial team chose a non-inferiority margin of 2%, which would have allowed them to conclude that non-sterile gloves are ‘non-inferior’ if the upper bound of the 95% …

中文翻译:

用于 ED 创伤伤口的无菌手套与非无菌手套

在他们的《急诊医学杂志》论文中,Zwaans 等人提出了一项随机对照试验,该试验询问在 ED 缝合创伤性伤口时,使用非无菌手套和敷料是否会影响感染风险。 大多数随机试验比较两种治疗方法,以便确定哪个更好。然而,在比较无菌手套和非无菌手套的效果时,这种“优越性”设计没有意义,因为没有理由认为非无菌手套在减少伤口感染方面应该更优越。尽管如此,如果非无菌手套“差不了多少”,可能还有其他理由更喜欢非无菌手套——也许是因为它们更便宜、更容易获得或产生的包装废物更少。Zwaans 等人因此选择了非劣效性试验设计。而不是问无菌或非无菌手套是否“更好”,他们的试验询问非无菌手套是否比无菌手套“差很多”。为了回答这样的问题,Zwaans 等人首先必须说明他们愿意接受的“差多少”。这种“非劣效性界限”是一个判断问题,取决于诸如无菌手套的缺点(例如成本、可及性和环境负担)以及它们试图避免的风险大小(例如伤口感染)等因素。试验小组选择了 2% 的非劣效性边际,如果 95% 的上限,他们可以得出结论,非无菌手套是“非劣质的”…… 这种“非劣效性界限”是一个判断问题,取决于诸如无菌手套的缺点(例如成本、可及性和环境负担)以及它们试图避免的风险大小(例如伤口感染)等因素。试验小组选择了 2% 的非劣效性边际,如果 95% 的上限,他们可以得出结论,非无菌手套是“非劣质的”…… 这种“非劣效性界限”是一个判断问题,取决于诸如无菌手套的缺点(例如成本、可及性和环境负担)以及它们试图避免的风险大小(例如伤口感染)等因素。试验小组选择了 2% 的非劣效性边际,如果 95% 的上限,他们可以得出结论,非无菌手套是“非劣质的”……
更新日期:2022-08-23
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