非无菌手套和敷料与无菌手套、敷料和铺巾在急诊科缝合创伤性伤口的比较：一项非劣效性多中心随机对照试验。

Non-sterile gloves and dressing versus sterile gloves, dressings and drapes for suturing of traumatic wounds in the emergency department: a non-inferiority multicentre randomised controlled trial.

机构信息

Department of Emergency Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands

Department of Emergency Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.

出版信息

Emerg Med J. 2022 Sep;39(9):650-654. doi: 10.1136/emermed-2021-211540. Epub 2022 Jul 26.

DOI:10.1136/emermed-2021-211540

PMID:35882525

Abstract

BACKGROUND

Patients with traumatic wounds frequently present to the ED. Literature on whether to treat these wounds sterile or non-sterile is sparse. Non-sterile treatment has the advantage of saving resources and costs, and could be of value in health settings where sterile materials are not readily available. Our objective was to compare the rate of wound infection after suturing traumatic lacerations with non-sterile gloves and dressings versus sterile gloves, dressings and drapes in the ED. We hypothesised that non-sterile gloves and dressings would be non-inferior to sterile gloves, dressings and drapes. The non-inferiority margin was set at 2%.

METHODS

A multicentre single-blinded randomised controlled trial testing for non-inferiority of non-sterile gloves and dressings versus sterile gloves, dressings and drapes for suturing of traumatic wounds was performed in 3 EDs in The Netherlands. Adults with uncomplicated wounds were included from July 2012 to December 2016. At the time of treatment, patient and wound characteristics and management were documented. The outcome was wound infection, which was identified during follow-up in the treating ED at 5-14 days postprocedure.

RESULTS

From 2468 eligible patients, 1480 were randomised in a sterile (n=747) or non-sterile (n=733) protocol. Baseline characteristics were similar in both study arms. The observed wound infection rate in the non-sterile group was 5.7% (95% CI 4.0% to 7.5%) vs 6.8% (95% CI 5.1% to 8.8%) in the sterile group. The mean difference of the wound infection rate of the two groups was -1.1% (95% CI -3.7% to 1.5%).

CONCLUSION

Although recruitment ceased prior to reaching our planned sample size, the findings suggest that there is unlikely to be a large difference between the non-sterile gloves, dressings and sterile gloves, dressings and drapes for suturing of traumatic wounds in the ED.

TRIAL REGISTRATION NUMBER

NL 34798.078.11, NTR3541.

摘要

背景

创伤性伤口患者经常到急诊科就诊。关于这些伤口是应进行无菌处理还是非无菌处理的文献很少。非无菌处理具有节省资源和成本的优势，并且在无菌材料不易获得的卫生环境中可能具有价值。我们的目的是比较在急诊科用非无菌手套和敷料与无菌手套、敷料和手术巾缝合创伤性撕裂伤后的伤口感染率。我们假设非无菌手套和敷料与无菌手套、敷料和手术巾相比不劣效。非劣效性边界设定为 2%。

方法

在荷兰的 3 家急诊科进行了一项多中心、单盲、随机对照试验，以检验非无菌手套和敷料与无菌手套、敷料和手术巾在缝合创伤性伤口方面的非劣效性。纳入 2012 年 7 月至 2016 年 12 月期间无并发症的伤口的成年人。在治疗时，记录患者和伤口特征以及治疗情况。结果是伤口感染，在治疗后的 5-14 天内在治疗急诊科通过随访确定。

结果

从 2468 名符合条件的患者中，有 1480 名患者按无菌（n=747）或非无菌（n=733）方案随机分组。两组的基线特征相似。非无菌组的观察到的伤口感染率为 5.7%（95%CI 4.0%至 7.5%），而无菌组为 6.8%（95%CI 5.1%至 8.8%）。两组之间的伤口感染率平均差异为-1.1%（95%CI -3.7%至 1.5%）。