Impact of intra-abdominal absorbable sutures on surgical site infection in gastrointestinal and hepato-biliary-pancreatic surgery: results of a multicenter, randomized, prospective, phase II clinical trial

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

Affiliations

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.

PMID: 28233105
DOI: 10.1007/s00595-017-1480-3

Review

Impact of intra-abdominal absorbable sutures on surgical site infection in gastrointestinal and hepato-biliary-pancreatic surgery: results of a multicenter, randomized, prospective, phase II clinical trial

Yoshihiko Maehara et al. Surg Today. 2017 Sep.

. 2017 Sep;47(9):1060-1071.

doi: 10.1007/s00595-017-1480-3. Epub 2017 Feb 23.

Authors

Affiliations

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.

PMID: 28233105
DOI: 10.1007/s00595-017-1480-3

Erratum in

Erratum to: Impact of intra-abdominal absorbable sutures on surgical site infection in gastrointestinal and hepato-biliary-pancreatic surgery: results of a multicenter, randomized, prospective, phase II clinical trial.
Maehara Y, Shirabe K, Kohnoe S, Emi Y, Oki E, Kakeji Y, Baba H, Ikeda M, Kobayashi M, Takayama T, Natsugoe S, Haraguchi M, Yoshida K, Terashima M, Sasako M, Yamaue H, Kokudo N, Uesaka K, Uemoto S, Kosuge T, Sawa Y, Shimada M, Doki Y, Yamamoto M, Taketomi A, Takeuchi M, Akazawa K, Yamanaka T, Shimokawa M. Maehara Y, et al. Surg Today. 2017 Dec;47(12):1539-1540. doi: 10.1007/s00595-017-1589-4. Surg Today. 2017. PMID: 28956067

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.

Keywords: Absorbable suture; Randomized prospective clinical trial; Silk suture; Surgery; Surgical site infection.

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References

1. Ann Surg. 2013 Oct;258(4):606-12; discussion 612-3 - PubMed
1. J Biomed Mater Res B Appl Biomater. 2005 Jul;74(1):627-35 - PubMed
1. Ann Surg. 2004 May;239(5):599-605; discussion 605-7 - PubMed
1. J Hepatobiliary Pancreat Surg. 2005;12(4):304-9 - PubMed
1. Am J Infect Control. 1991 Feb;19(1):19-35 - PubMed

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Impact of intra-abdominal absorbable sutures on surgical site infection in gastrointestinal and hepato-biliary-pancreatic surgery: results of a multicenter, randomized, prospective, phase II clinical trial

Affiliations

Impact of intra-abdominal absorbable sutures on surgical site infection in gastrointestinal and hepato-biliary-pancreatic surgery: results of a multicenter, randomized, prospective, phase II clinical trial

Authors

Affiliations

Erratum in

Abstract

References

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