Subcuticular sutures versus staples for skin closure after open gastrointestinal surgery: A phase 3, multicentre, open-label, randomised controlled trial

Toshimasa Tsujinaka, Kazuyoshi Yamamoto, Junya Fujita, Shunji Endo, Junji Kawada, Shin Nakahira, Toshio Shimokawa, Shogo Kobayashi, Makoto Yamasaki, Yusuke Akamaru, Atsushi Miyamoto, Tsunekazu Mizushima, Junzo Shimizu, Koji Umeshita, Toshinori Ito, Yuichiro Doki, Masaki Mori

研究成果: ジャーナルへの寄稿記事

26 引用 (Scopus)

抜粋

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 not validated as an improvement over a standard procedure for skin closure to reduce the incidence of wound complications after open gastrointestinal surgery.

元の言語英語
ページ(範囲)1105-1112
ページ数8
ジャーナルThe Lancet
382
発行部数9898
DOI
出版物ステータス出版済み - 1 1 2013

    フィンガープリント

All Science Journal Classification (ASJC) codes

  • Medicine(all)

これを引用