S Kobayashi1, M Ito, S Yamamoto, Y Kinugasa, M Kotake, Y Saida, T Kobatake, T Yamanaka, N Saito, Y Moriya. 1. Department of Colorectal Surgery, National Cancer Centre Hospital East, Kashiwa, Japan; Department of Surgery, Toho University Ohashi Medical Centre, Tokyo, Japan; Department of Surgery, Tokyo Metropolitan Komagome Hospital, Tokyo, Japan.
Abstract
BACKGROUND: The best suture method to prevent incisional surgical-site infection (SSI) after clean-contaminated surgery has not been clarified. METHODS:Patients undergoing elective colorectal cancer surgery at one of 16 centres were randomized to receive either subcuticular sutures or skin stapling for skin closure. The primary endpoint was the rate of incisional SSI. Secondary endpoints of interest included time required for wound closure, incidence of wound problems, postoperative length of stay, wound aesthetics and patient satisfaction. RESULTS: A total of 1264 patients were enrolled. The cumulative incidence of incisional SSI by day 30 after surgery was similar after subcuticular sutures and stapled closure (8·7 versus 9·8 per cent respectively; P = 0·576). Comparison of cumulative incidence curves revealed that SSI occurred later in the subcuticular suture group (P = 0·019) (hazard ratio 0·66, 95 per cent c.i. 0·45 to 0·97). Wound problems (P = 0·484), wound aesthetics (P = 0·182) and postoperative duration of hospital stay (P = 0·510) did not differ between the groups; subcuticular sutures took 5 min longer than staples (P < 0·001). Patients in the subcuticular suture group were significantly more satisfied with their wound (52·4 per cent versus 42·7 per cent in the staple group; P = 0·002). CONCLUSION: Compared with skin stapling, subcuticular sutures did not reduce the risk of incisional SSI after colorectal surgery. REGISTRATION NUMBER: UMIN000004001 (http://www.umin.ac.jp/ctr).
RCT Entities:
BACKGROUND: The best suture method to prevent incisional surgical-site infection (SSI) after clean-contaminated surgery has not been clarified. METHODS:Patients undergoing elective colorectal cancer surgery at one of 16 centres were randomized to receive either subcuticular sutures or skin stapling for skin closure. The primary endpoint was the rate of incisional SSI. Secondary endpoints of interest included time required for wound closure, incidence of wound problems, postoperative length of stay, wound aesthetics and patient satisfaction. RESULTS: A total of 1264 patients were enrolled. The cumulative incidence of incisional SSI by day 30 after surgery was similar after subcuticular sutures and stapled closure (8·7 versus 9·8 per cent respectively; P = 0·576). Comparison of cumulative incidence curves revealed that SSI occurred later in the subcuticular suture group (P = 0·019) (hazard ratio 0·66, 95 per cent c.i. 0·45 to 0·97). Wound problems (P = 0·484), wound aesthetics (P = 0·182) and postoperative duration of hospital stay (P = 0·510) did not differ between the groups; subcuticular sutures took 5 min longer than staples (P < 0·001). Patients in the subcuticular suture group were significantly more satisfied with their wound (52·4 per cent versus 42·7 per cent in the staple group; P = 0·002). CONCLUSION: Compared with skin stapling, subcuticular sutures did not reduce the risk of incisional SSI after colorectal surgery. REGISTRATION NUMBER: UMIN000004001 (http://www.umin.ac.jp/ctr).
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