PEDEGO Research Unit, Medical Research Centre, University of Oulu, Oulu, Finland; Oulu University Hospital, Department of Children and Adolescents, Oulu, Finland.
PEDEGO Research Unit, Medical Research Centre, University of Oulu, Oulu, Finland; Oulu University Hospital, Department of Children and Adolescents, Oulu, Finland.
Lancet Infect Dis. 2017 Jan;17(1):50-57. doi: 10.1016/S1473-3099(16)30373-5. Epub 2016 Sep 19.
Surgical site infections (SSIs) are a pervasive problem in surgery. Sutures coated or impregnated with triclosan might reduce the occurrence of SSIs, but evidence of their efficacy is limited, especially in children.
We designed a randomised, double-blind, controlled trial in patients who underwent elective or daytime emergency surgery at Oulu University Hospital (Oulu, Finland). We included children younger than 18 years staying in the paediatric surgery and orthopaedics ward for any elective or emergency surgery during the daytime and with anticipated use of absorbing sutures. Children were randomly allocated (1:1) to receive either triclosan-containing sutures or ordinary absorbing sutures. The primary outcome was the occurrence of superficial or deep surgical site infections according to the Centers for Disease Control and Prevention criteria within 30 days after surgery. The primary analysis was with modified intention to treat. This trial is registered at ClinicalTrials.gov, number NCT01220700.
Between September, 2010, and December, 2014, 1633 children were recruited. In the modified intention-to-treat group, SSIs occurred in 20 (3%) of 778 patients allocated to receive triclosan-containing sutures and in 42 (5%) of 779 patients allocated to receive control sutures (risk ratio 0·48, 95% CI 0·28-0·80). To prevent one SSI, triclosan-containing sutures had to be used in 36 children (95% CI 21-111). One patient died from suspected mitochondrial disease; no other expected or unexpected adverse events were reported in either of the groups.
Use of triclosan-containing sutures effectively reduced the occurrence of all SSIs compared with normal sutures. The results accord with the results of meta-analyses of previous studies in adults. Use of triclosan-containing sutures is a simple way to reduce SSIs in children.
The Alma and K A Snellman Foundation.
手术部位感染（SSI）是手术中普遍存在的问题。用三氯生涂覆或浸渍的缝线可能会减少 SSI 的发生，但它们的疗效证据有限，尤其是在儿童中。
我们在奥卢大学医院（芬兰奥卢）进行了一项随机、双盲、对照试验，纳入白天择期或紧急手术的患者。我们纳入了在儿科外科和骨科病房接受日间择期或紧急手术且预计使用可吸收缝线的 18 岁以下儿童。将儿童以 1:1 的比例随机分配接受含三氯生缝线或普通可吸收缝线。主要结局是根据疾病预防控制中心的标准，术后 30 天内发生的浅表或深部手术部位感染。主要分析采用意向治疗修改法。该试验在 ClinicalTrials.gov 注册，编号为 NCT01220700。
2010 年 9 月至 2014 年 12 月期间，共纳入 1633 名儿童。在改良意向治疗组中，接受含三氯生缝线的 778 名患者中有 20 名（3%）发生 SSI，接受对照缝线的 779 名患者中有 42 名（5%）发生 SSI（风险比 0.48，95%CI 0.28-0.80）。为预防一例 SSI，需要在 36 名儿童（95%CI 21-111）中使用含三氯生缝线。一名患者死于疑似线粒体疾病；两组均未报告其他预期或意外的不良事件。
与普通缝线相比，使用含三氯生缝线可有效降低所有 SSI 的发生率。这些结果与先前成人荟萃分析的结果一致。使用含三氯生缝线是减少儿童 SSI 的一种简单方法。
Alma 和 K A Snellman 基金会。
