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 and dressings for suturing of traumatic wounds and sterile gloves, dressings and drapes for suturing of traumatic wounds in the ED. Trial registration number NL 34798.078.11, NTR3541. Data are available on reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information.

中文翻译：

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非无菌手套和敷料与无菌手套、敷料和手术单用于急诊科创伤性伤口缝合：一项非劣效性多中心随机对照试验

背景 患有外伤的患者经常到急诊室就诊。关于是否对这些伤口进行无菌或非无菌治疗的文献很少。非无菌处理具有节省资源和成本的优点，并且在不易获得无菌材料的卫生环境中可能具有价值。我们的目的是比较急诊室使用非无菌手套和敷料与无菌手套、敷料和手术单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不劣于无菌手套、敷料和手术巾。非劣效裕度设定为2%。方法 在荷兰的 3 个急诊室进行了一项多中心单盲随机对照试验，测试非无菌手套和敷料与无菌手套、敷料和手术单缝合创伤伤口时的非劣效性。2012 年 7 月至 2016 年 12 月期间，有无复杂伤口的成年人被纳入研究。在治疗时，记录了患者和伤口的特征以及处理情况。结果是伤口感染，这是在术后 5-14 天的治疗 ED 随访过程中发现的。结果 在 2468 名符合条件的患者中，1480 名患者被随机分配到无菌 (n=747) 或非无菌 (n=733) 方案中。两个研究组的基线特征相似。观察到的非无菌组伤口感染率为 5.7%（95% CI 4.0% 至 7.5%），而无菌组为 6.8%（95% CI 5.1% 至 8.8%）。两组伤口感染率的平均差异为-1.1%（95% CI -3.7%至1.5%）。结论 尽管在达到我们计划的样本量之前就停止了招募，但研究结果表明，用于缝合外伤伤口的非无菌手套和敷料与用于缝合外伤伤口的无菌手套、敷料和手术巾之间不太可能有太大差异。急诊室。试用注册号 NL 34798.078.11、NTR3541。可根据合理要求提供数据。与研究相关的所有数据都包含在文章中或作为补充信息上传。