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


RESULTS
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).


CONCLUSIONS
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.


BACKGROUND
Johnson & Johnson.
Department of Surgery, Kaizuka City Hospital, Osaka, Japan. tsujinaka@hosp.kaizuka.osaka.jp
Toshimasa
T
Tsujinaka
Kazuyoshi
K
Yamamoto
Junya
J
Fujita
Shunji
S
Endo
Junji
J
Kawada
Shin
S
Nakahira
Toshio
T
Shimokawa
Shogo
S
Kobayashi
Makoto
M
Yamasaki
Yusuke
Y
Akamaru
Atsushi
A
Miyamoto
Tsunekazu
T
Mizushima
Junzo
J
Shimizu
Koji
K
Umeshita
Toshinori
T
Ito
Yuichiro
Y
Doki
Masaki
M
Mori
D000368:Aged; D017439:Cicatrix, Hypertrophic / Q000209:etiology*; D013505:Digestive System Surgical Procedures / Q000009:adverse effects*; D005260:Female; D005767:Gastrointestinal Diseases / Q000601:surgery*; D006801:Humans; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D017792:Surgical Stapling / Q000009:adverse effects*; D013530:Surgical Wound Infection / Q000209:etiology*; D013537:Sutures / Q000009:adverse effects*; D016896:Treatment Outcome; D014945:Wound Healing / Q000502:physiology