Imamura Kazuhiro, Adachi Kensuke, Sasaki Ritsuko, Monma Satoko, Shioiri Sadaaki, Seyama Yasuji, Miura Masaru, Morikawa Yoshihiko, Kaneko Tetsuji
Department of Surgery, Tokyo Metropolitan Tama Medical Center, Tokyo, Japan.
Department of Surgery, Ebara Hospital, Tokyo Metropolitan Health and Medical Corporation, 4-5-10 Higashi-Yukigaya, Ohta-ku, Tokyo, 145-0065, Japan.
J Gastrointest Surg. 2016 Dec;20(12):2083-2092. doi: 10.1007/s11605-016-3283-z. Epub 2016 Oct 3.
The incisional surgical site infection (SSI) is an extremely common complication following open abdominal surgery and imposes a considerable treatment and cost burden.
We conducted a multicenter open-label randomized controlled trial at three Tokyo Metropolitan medical institutions. We enrolled adult patients who underwent either an elective or an emergency open laparotomy. Eligible patients were allocated preoperatively to undergo wound closure with either subcuticular sutures or staples. A central Web-based randomization tool was used to assign participants randomly by a permuted block sequence with a 1:1 allocation ratio and a block size of 4 before mass closure to each group. The primary endpoint was the occurrence of a superficial SSI within 30 days after surgery in accordance with the Centers for Disease Control and Prevention criteria. This trial was registered with UMIN-CTR as UMIN 000004836 ( http://www.umin.ac.jp/ctr ).
Between September 1, 2010 and August 31, 2015, 401 patients were enrolled and randomly assigned to either group. One hundred and ninety-nine patients were allocated to the subcuticular suture and 202 patients to the staple groups (hereafter the "suture" and "staple" group, respectively). Three hundred and ninety-nine were eligible for the primary endpoint. Superficial SSIs occurred in 25 of 198 suture patients and in 27 of 201 staple patients. Overall, the rate of superficial SSIs did not differ significantly between the suture and staple groups.
Subcuticular sutures did not increase the occurrence of superficial SSIs following open laparotomies mainly consisting of clean-contaminated surgical procedures. The applicability of the wound closure material and method is likely to depend on individual circumstances of the patient and surgical procedure.
切口手术部位感染（SSI）是开腹手术后极为常见的并发症，带来了相当大的治疗和成本负担。
我们在东京都的三家医疗机构开展了一项多中心开放标签随机对照试验。纳入接受择期或急诊开腹手术的成年患者。符合条件的患者术前被分配接受皮下缝合或吻合器伤口闭合。使用基于网络的中央随机化工具，在大规模闭合前按1:1分配比例和4的区组大小，通过置换区组序列将参与者随机分配到每组。主要终点是根据疾病控制与预防中心标准，术后30天内发生的浅表SSI。本试验在UMIN-CTR注册为UMIN 000004836（http://www.umin.ac.jp/ctr）。
2010年9月1日至2015年8月31日期间，401例患者入组并随机分配到两组。199例患者被分配到皮下缝合组，202例患者被分配到吻合器组（以下分别称为“缝合”组和“吻合器”组）。399例符合主要终点标准。198例缝合组患者中有25例发生浅表SSI，201例吻合器组患者中有27例发生浅表SSI。总体而言，缝合组和吻合器组之间浅表SSI的发生率无显著差异。
在主要由清洁-污染手术构成的开腹手术后，皮下缝合并未增加浅表SSI的发生率。伤口闭合材料和方法的适用性可能取决于患者的个体情况和手术操作。
