Yoshihiko Maehara1, Ken Shirabe2, Shunji Kohnoe1, Yasunori Emi1, Eiji Oki1, Yoshihiro Kakeji3, Hideo Baba4, Masataka Ikeda5, Michiya Kobayashi6, Tadatoshi Takayama7, Shoji Natsugoe8, Masashi Haraguchi9, Kazuhiro Yoshida10, Masanori Terashima11, Mitsuru Sasako12, Hiroki Yamaue13, Norihiro Kokudo14, Katsuhiko Uesaka15, Shinji Uemoto16, Tomoo Kosuge17, Yoshiki Sawa18, Mitsuo Shimada19, Yuichiro Doki5, Masakazu Yamamoto20, Akinobu Taketomi21, Masahiro Takeuchi22, Kouhei Akazawa23, Takeharu Yamanaka24, Mototsugu Shimokawa25. 1. Department of Surgery and Science, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan. 2. Department of Surgery and Science, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan. kshirabe@surg2.med.kyushu-u.ac.jp. 3. Division of Gastrointestinal Surgery, Department of Surgery, Kobe University, Kobe, Japan. 4. Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan. 5. Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan. 6. Department of Human Health and Medical Sciences, Hospital Administration Section, Kochi Medical School, Kochi, Japan. 7. Department of Digestive Surgery, Nihon University School of Medicine, Tokyo, Japan. 8. Department of Digestive Surgery, Breast and Thyroid Surgery, Graduate School of Medicine, Kagoshima University, Kagoshima, Japan. 9. Department of Surgery, Nagasaki University Graduate School of Biomedical Science, Nagasaki, Japan. 10. Department of Surgical Oncology, Graduate School of Medicine, Gifu University, Gifu, Japan. 11. Division of Gastric Surgery, Shizuoka Cancer Center, Shizuoka, Japan. 12. Department of Surgery, Hyogo College of Medicine, Nishinomiya, Japan. 13. Second Department of Surgery, School of Medicine, Wakayama Medical University, Wakayama, Japan. 14. Hepato-Biliary-Pancreatic Surgery Division, Artificial Organ and Transplantation Division, Department of Surgery, Graduate School of Medicine, University of Tokyo, Tokyo, Japan. 15. Division of Hepato-Biliary-Pancreatic Surgery, Shizuoka Cancer Center, Shizuoka, Japan. 16. Division of Hepato-Biliary-Pancreatic Surgery and Transplantation Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan. 17. Hepatobiliary and Pancreatic Surgery Division, National Cancer Center Hospital, Tokyo, Japan. 18. Department of Cardiovascular Surgery, Graduate School of Medicine, Osaka University, Oksaka, Japan. 19. Department of Surgery, The University of Tokushima, Tokushima, Japan. 20. Department of Surgery, Institute of Gastroenterology, Tokyo Women's Medical University, Tokyo, Japan. 21. Department of Gastroenterological Surgery I, Graduate School of Medicine, Hokkaido University, Sapporo, Japan. 22. Department of Clinical Medicine (Biostatistics and Pharmaceutical Medicine), School of Pharmacy, Kitasato University, Tokyo, Japan. 23. Department of Medical Informatics, Niigata University Medical and Dental Hospital, Niigata, Japan. 24. Department of Biostatistics, Yokohama City University, Yokohama, Japan. 25. Department of Cancer Information Research, Kyushu Cancer Center, Fukuoka, Japan.
Abstract
BACKGROUND: The use of absorbable sutures in wound closure has been shown to reduce the incidence of surgical site infection (SSI); however, there is no evidence that the intra-abdominal use of absorbable rather than silk sutures reduces the incidence of SSI after gastrointestinal surgery. We report the findings of a phase II trial, designed to evaluate the impact of the intra-abdominal use of absorbable sutures on the incidence of SSI. METHODS:At 19 Japanese hospitals, 1147 patients undergoing elective gastrectomy, colorectal surgery, hepatectomy, or pancreaticoduodenectomy (PD) were randomly assigned to absorbable or silk intra-abdominal suture groups. The primary efficacy endpoint was the incidence of SSI. The secondary efficacy endpoints were the locations of SSI, time to resolution of SSI, length of hospital stay, and the incidence of bile leakage in hepatectomy and pancreatic fistula. RESULTS: The incidence of SSI was 11.3%, 15.5%, 11.3%, and 36.9% after gastrectomy, colorectal surgery, hepatectomy, and PD, respectively. The incidence of SSI was higher in the absorbable suture group than in the silk suture group for all the surgical procedures, but the difference was not significant. CONCLUSION: The intra-abdominal use of absorbable sutures did not have enough of an effect on the reduction of SSI in this phase II trial to justify the planning of a large-scale phase III trial.
RCT Entities:
BACKGROUND: The use of absorbable sutures in wound closure has been shown to reduce the incidence of surgical site infection (SSI); however, there is no evidence that the intra-abdominal use of absorbable rather than silk sutures reduces the incidence of SSI after gastrointestinal surgery. We report the findings of a phase II trial, designed to evaluate the impact of the intra-abdominal use of absorbable sutures on the incidence of SSI. METHODS: At 19 Japanese hospitals, 1147 patients undergoing elective gastrectomy, colorectal surgery, hepatectomy, or pancreaticoduodenectomy (PD) were randomly assigned to absorbable or silk intra-abdominal suture groups. The primary efficacy endpoint was the incidence of SSI. The secondary efficacy endpoints were the locations of SSI, time to resolution of SSI, length of hospital stay, and the incidence of bile leakage in hepatectomy and pancreatic fistula. RESULTS: The incidence of SSI was 11.3%, 15.5%, 11.3%, and 36.9% after gastrectomy, colorectal surgery, hepatectomy, and PD, respectively. The incidence of SSI was higher in the absorbable suture group than in the silk suture group for all the surgical procedures, but the difference was not significant. CONCLUSION: The intra-abdominal use of absorbable sutures did not have enough of an effect on the reduction of SSI in this phase II trial to justify the planning of a large-scale phase III trial.
Authors: Genevieve B Melton; Jon D Vogel; Brian R Swenson; Feza H Remzi; David A Rothenberger; Elizabeth C Wick Journal: Ann Surg Date: 2013-10 Impact factor: 12.969
Authors: Robert L Smith; Jamie K Bohl; Shannon T McElearney; Charles M Friel; Margaret M Barclay; Robert G Sawyer; Eugene F Foley Journal: Ann Surg Date: 2004-05 Impact factor: 12.969
Authors: T G Emori; D H Culver; T C Horan; W R Jarvis; J W White; D R Olson; S Banerjee; J R Edwards; W J Martone; R P Gaynes Journal: Am J Infect Control Date: 1991-02 Impact factor: 2.918
Authors: Gill Norman; Chunhu Shi; En Lin Goh; Elizabeth Ma Murphy; Adam Reid; Laura Chiverton; Monica Stankiewicz; Jo C Dumville Journal: Cochrane Database Syst Rev Date: 2022-04-26
Authors: Joan Webster; Zhenmi Liu; Gill Norman; Jo C Dumville; Laura Chiverton; Paul Scuffham; Monica Stankiewicz; Wendy P Chaboyer Journal: Cochrane Database Syst Rev Date: 2019-03-26
Authors: Gill Norman; En Lin Goh; Jo C Dumville; Chunhu Shi; Zhenmi Liu; Laura Chiverton; Monica Stankiewicz; Adam Reid Journal: Cochrane Database Syst Rev Date: 2020-05-01
Authors: Gill Norman; En Lin Goh; Jo C Dumville; Chunhu Shi; Zhenmi Liu; Laura Chiverton; Monica Stankiewicz; Adam Reid Journal: Cochrane Database Syst Rev Date: 2020-06-15