title: Randomized Comparison of Subcuticular Sutures Versus Staples for Skin Closure After Open Abdominal Surgery: a Multicenter Open-Label Randomized Controlled Trial.
abstract: 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.
authors.affiliation: Department of Surgery, Tokyo Metropolitan Tama Medical Center, Tokyo, Japan.
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Imamura
authors.affiliation: Department of Surgery, Tokyo Metropolitan Tama Medical Center, Tokyo, Japan. kensuke_adachi@tokyo-hmt.jp.|Department of Surgery, Ebara Hospital, Tokyo Metropolitan Health and Medical Corporation, 4-5-10 Higashi-Yukigaya, Ohta-ku, Tokyo, 145-0065, Japan. kensuke_adachi@tokyo-hmt.jp.
authors.forename: Kensuke
authors.initials: K
authors.lastname: Adachi
authors.affiliation: Department of Surgery, Tokyo Metropolitan Tama Medical Center, Tokyo, Japan.
authors.forename: Ritsuko
authors.initials: R
authors.lastname: Sasaki
authors.affiliation: Department of Surgery, Tokyo Metropolitan Tama Medical Center, Tokyo, Japan.
authors.forename: Satoko
authors.initials: S
authors.lastname: Monma
authors.affiliation: Department of Surgery, Tokyo Metropolitan Hiroo Hospital, Tokyo, Japan.
authors.forename: Sadaaki
authors.initials: S
authors.lastname: Shioiri
authors.affiliation: Department of Surgery, Tokyo Metropolitan Bokutoh Hospital, Tokyo, Japan.
authors.forename: Yasuji
authors.initials: Y
authors.lastname: Seyama
authors.affiliation: Department of Clinical Research Support Center, Tokyo Metropolitan Children's Medical Center, Tokyo, Japan.
authors.forename: Masaru
authors.initials: M
authors.lastname: Miura
authors.affiliation: Department of Clinical Research Support Center, Tokyo Metropolitan Children's Medical Center, Tokyo, Japan.
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Morikawa
authors.affiliation: Department of Clinical Research Support Center, Tokyo Metropolitan Children's Medical Center, Tokyo, Japan.
authors.forename: Tetsuji
authors.initials: T
authors.lastname: Kaneko
mesh_terms: D000005:Abdomen / Q000601:surgery*; D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017792:Surgical Stapling / Q000009:adverse effects*; D013530:Surgical Wound Infection / Q000209:etiology*; D013537:Sutures / Q000009:adverse effects*
keywords: Open abdominal surgery; Staple; Subcuticular suture; Surgical site infection