Tadatoshi Takayama1, Osamu Aramaki2, Taro Shibata3, Masaaki Oka4, Toshiyuki Itamoto5, Mitsuo Shimada6, Shuji Isaji7, Takashi Kanematsu8, Shoji Kubo9, Masato Kusunoki10, Hidetaka Mochizuki11, Yoshinobu Sumiyama12. 1. Department of Digestive Surgery, Nihon University School of Medicine, 30-1 Ohyaguchikami-cho, Itabashi-ku, Tokyo, 173-8610, Japan. takayama.tadatoshi@nihon-u.ac.jp. 2. Department of Digestive Surgery, Nihon University School of Medicine, 30-1 Ohyaguchikami-cho, Itabashi-ku, Tokyo, 173-8610, Japan. 3. Biostatistics Division, Center for Research Administration and Support, National Cancer Center, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104- 0045, Japan. 4. Department of Digestive Surgery and Surgical Oncology, Faculty of Medicine, Yamaguchi University, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan. 5. Department of Gastroenterological and Transplant Surgery, Hiroshima University School of Medicine, 1-2-3, Kasumi, Minami-Ku, Hiroshima, 734-8551, Japan. 6. Department of Digestive and Transplantation Surgery, Tokushima University School of Medicine, 3-18-15, Kuramoto-cho, Tokushima, 770-8503, Japan. 7. Department of Hepatobiliary Pancreatic and Transplant Surgery, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu City, Mie, 514-8507, Japan. 8. Department of Surgery, Nagasaki University School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki, 852-8501, Japan. 9. Department of Hepatobiliary Pancreatic Surgery, Osaka City University Graduate School of Medicine, 1-4-3 Asahi-machi, Abeno-ku, Osaka-City, Osaka, 545-8585, Japan. 10. Department of Gastrointestinal and Pediatric Surgery, Division of Reparative Medicine, Institute of Life Sciences, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, 514-8507, Mie, Japan. 11. Department of Surgery, National Defense Medical College, 3-2, Namiki, Tokorozawa, Saitama, 359-8513, Japan. 12. Chairman of the Board of Directors, Toho University, 5-21-16 Omori-nishi, Ota-ku, Tokyo, 143-8510, Japan.
Abstract
PURPOSES: This study compared the effectiveness of 1-day vs 3-days antibiotic regimen to prevent surgical site infection (SSI) in open liver resection. METHOD: We performed a randomized controlled non-inferiority trial in 480 patients at 39 hospitals across Japan (registered as UMIN000002852). Patients with hepatocellular carcinoma scheduled to undergo resection were randomly assigned to receive either a 1-day regimen for antimicrobial prophylaxis, or a 3-day regimen. The primary endpoint was the incidence of SSI. RESULTS: Among 480 randomized patients, 232 assigned to the 1-day regimen and 235 to the 3-day regimen were included in the full analysis set. Baseline characteristics of the two groups were well balanced. SSI was diagnosed in 22 patients (9.5%) in the 1-day group vs 23 patients (9.8%) in the 3-day group (difference, - 0.30; 90% CI - 4.80 to 4.19% [95% CI - 5.66% to 5.05%]; one-sided P = 0.001 for non-inferiority), meeting the non-inferiority hypothesis. In both groups, remote site infection (16 [6.9%] vs 22 [9.4%], P ˂ 0.001 for non-inferiority) and drain-related infection (5 [2.2%] vs 4 [1.7%], P ˂ 0.001 for non-inferiority) were comparable. CONCLUSION: To prevent SSI in liver cancer surgery, a 1-day regimen of flomoxef sodium is recommended for antimicrobial prophylaxis because of confirming the non-inferiority to longer usage.
RCT Entities:
PURPOSES: This study compared the effectiveness of 1-day vs 3-days antibiotic regimen to prevent surgical site infection (SSI) in open liver resection. METHOD: We performed a randomized controlled non-inferiority trial in 480 patients at 39 hospitals across Japan (registered as UMIN000002852). Patients with hepatocellular carcinoma scheduled to undergo resection were randomly assigned to receive either a 1-day regimen for antimicrobial prophylaxis, or a 3-day regimen. The primary endpoint was the incidence of SSI. RESULTS: Among 480 randomized patients, 232 assigned to the 1-day regimen and 235 to the 3-day regimen were included in the full analysis set. Baseline characteristics of the two groups were well balanced. SSI was diagnosed in 22 patients (9.5%) in the 1-day group vs 23 patients (9.8%) in the 3-day group (difference, - 0.30; 90% CI - 4.80 to 4.19% [95% CI - 5.66% to 5.05%]; one-sided P = 0.001 for non-inferiority), meeting the non-inferiority hypothesis. In both groups, remote site infection (16 [6.9%] vs 22 [9.4%], P ˂ 0.001 for non-inferiority) and drain-related infection (5 [2.2%] vs 4 [1.7%], P ˂ 0.001 for non-inferiority) were comparable. CONCLUSION: To prevent SSI in liver cancer surgery, a 1-day regimen of flomoxef sodium is recommended for antimicrobial prophylaxis because of confirming the non-inferiority to longer usage.
Authors: Anastasia Murtha-Lemekhova; Juri Fuchs; Miriam Teroerde; Ute Chiriac; Rosa Klotz; Daniel Hornuss; Jan Larmann; Markus A Weigand; Katrin Hoffmann Journal: Antibiotics (Basel) Date: 2022-05-12