エンドウ　シュンジ   Shunji Endo   遠藤　俊治    所属   川崎医科大学  医学部 臨床医学　消化器外科学    職種   准教授
論文種別	原著
言語種別	英語
査読の有無	査読あり
表題	Subcuticular sutures versus staples for skin closure after open gastrointestinal surgery: a phase 3, multicentre, open-label, randomised controlled trial.
掲載誌名	正式名：Lancet (London, England) 略　 称：Lancet ISSNコード：1474547X/01406736
掲載区分	国外
巻・号・頁	382(9898),pp.1105-12
著者・共著者	Tsujinaka Toshimasa, Yamamoto Kazuyoshi, Fujita Junya, Endo Shunji, Kawada Junji, Nakahira Shin, Shimokawa Toshio, Kobayashi Shogo, Yamasaki Makoto, Akamaru Yusuke, Miyamoto Atsushi, Mizushima Tsunekazu, Shimizu Junzo, Umeshita Koji, Ito Toshinori, Doki Yuichiro, Mori Masaki,
発行年月	2013/09
概要	BACKGROUND:Staples have been widely used for skin closure after open gastrointestinal surgery. The potential advantages of subcuticular sutures compared with staples have not been assessed. We assessed the differences in the frequency of wound complications, including superficial incisional surgical site infection and hypertrophic scar formation, depending on whether subcuticular sutures or staples are used.METHODS:We did a multicentre, open-label, randomised controlled trial at 24 institutions between June 1, 2009, and Feb 28, 2012. Eligible patients aged 20 years or older, with adequate organ function and undergoing elective open upper or lower gastrointestinal surgery, were randomly assigned preoperatively to either staples or subcuticular sutures for skin closure. Randomisation was done via a computer-generated permuted-block sequence, and was stratified by institution, sex, and type of surgery (ie, upper or lower gastrointestinal surgery). Our primary endpoint was the incidence of wound complications within 30 days of surgery. Analysis was done by intention to treat. This study is registered with UMINCTR, UMIN000002480.FINDINGS:1080 patients were enrolled and randomly assigned in a one to one ratio: 562 to subcuticular sutures and 518 to staples. 1072 were eligible for the primary endpoint and 1058 for the secondary endpoint. Of the 558 patients who received subcuticular sutures, 382 underwent upper gastrointestinal surgery and 176 underwent lower gastrointestinal surgery. Wound complications occurred in 47 of 558 patients (8·4%, 95% CI 6·3-11·0). Of the 514 who received staples, 413 underwent upper gastrointestinal surgery and 101 underwent lower gastrointestinal surgery. Wound complications occurred in 59 of 514 (11·5%, 95% CI 8·9-14·6). Overall, the rate of wound complications did not differ significantly between the subcuticular sutures and staples groups (odds ratio 0·709, 95% CI 0·474-1·062; p=0·12).INTERPRETATION:The efficacy of subcuticular sutures was
DOI	10.1016/S0140-6736(13)61780-8
PMID	24075050