野田 弘志

BACKGROUND: Surgical site infection is one of the most common postoperative complications after gastroenterologic surgery. This study investigated the effect of triclosan-coated sutures in decreasing the incidence of surgical site infections after abdominal wall closure in gastroenterologic surgery. METHODS: A prospective, double-blind, randomized, controlled parallel adaptive group-sequential superiority trial was conducted from March 2014 to March 2017 in a single center. Eligible patients were those who underwent gastroenterologic surgery. Patients were allocated randomly to receive either abdominal wall closure with triclosan-coated sutures (the study group) or sutures without triclosan (the control group). The primary end point was the incidence of superficial or deep surgical site infections within 30 days after operation. This study was registered with the University Hospital Medical Information Network-Clinical Trials Registry (http://www.umin.ac.jp/ctr/), identification number UMIN000013054. RESULTS: A total of 1,013 patients (study group, 508 patients; control group, 505 patients) were analyzed by a modified intention-to-treat approach. The wounds in 990 (97.7%) of the 1,013 patients were classified as clean-contaminated. The primary end point (incidence of superficial or deep surgical site infections) was 35 (6.9%) of 508 patients in the study group and 30 (5.9%) of 505 in the control group. The incidence of surgical site infections did not differ markedly between the 2 groups (95% confidence interval: 0.686-2.010, P = .609). Of the 65 infections, 42 (64.6%) were superficial surgical site infections, with similar frequencies in the 2 groups, and 23 (35.4%) were deep surgical site infections, again with similar frequencies in the 2 groups. CONCLUSION: Triclosan-coated sutures did not decrease the incidence of surgical site infections after abdominal wall closure in gastroenterologic surgery.