Hirotoshi Kobayashi1, Hiroyuki Uetake2, Masamichi Yasuno2, Kenichi Sugihara2. 1. Department of Surgery, Tokyo Metropolitan Hiroo Hospital, Tokyo, Japanh-kobayashi.srg2@tmd.ac.jp. 2. Department of Surgical Oncology, Graduate School, Tokyo Medical and Dental University, Tokyo, Japan.
Abstract
BACKGROUND: Standard procedures to reduce the surgical site infection (SSI) rate after colorectal surgery have not been established. A prospective cohort study with 2 parallel study groups was performed to clarify the SSI rate after open surgery with and without a wound-edge protector (WEP) for colorectal disease. METHODS: A total of 102 patients who underwent elective open surgery for colorectal disease between October 2012 and August 2014 were randomly assigned to a WEP group and a WEP (-) group. The primary endpoint was the SSI rate in both groups. RESULTS: Fifty-one patients were assigned to the WEP group and 51 to the WEP (-) group. Two patients were excluded from this study. The rate of SSI with and without a WEP was 16 and 36% respectively (p = 0.021). Older age (p = 0.0073) and no WEP (p = 0.021) were risk factors for SSI after open surgery for colorectal diseases on univariate analysis. On multivariate analysis, both older age (p = 0.016) and no WEP (p = 0.012) were independent risk factors for SSI. CONCLUSION: The present randomized, phase II trial found an SSI rate of 16% with use of a WEP. The SSI rate was lower in the WEP group than in the WEP (-) group. A WEP may reduce the SSI rate after open surgery for colorectal disease in Japanese patients.
RCT Entities:
BACKGROUND: Standard procedures to reduce the surgical site infection (SSI) rate after colorectal surgery have not been established. A prospective cohort study with 2 parallel study groups was performed to clarify the SSI rate after open surgery with and without a wound-edge protector (WEP) for colorectal disease. METHODS: A total of 102 patients who underwent elective open surgery for colorectal disease between October 2012 and August 2014 were randomly assigned to a WEP group and a WEP (-) group. The primary endpoint was the SSI rate in both groups. RESULTS: Fifty-one patients were assigned to the WEP group and 51 to the WEP (-) group. Two patients were excluded from this study. The rate of SSI with and without a WEP was 16 and 36% respectively (p = 0.021). Older age (p = 0.0073) and no WEP (p = 0.021) were risk factors for SSI after open surgery for colorectal diseases on univariate analysis. On multivariate analysis, both older age (p = 0.016) and no WEP (p = 0.012) were independent risk factors for SSI. CONCLUSION: The present randomized, phase II trial found an SSI rate of 16% with use of a WEP. The SSI rate was lower in the WEP group than in the WEP (-) group. A WEP may reduce the SSI rate after open surgery for colorectal disease in Japanese patients.
Authors: Jaime Ruiz-Tovar; Marja A Boermeester; Liliana Bordeianou; George J Chang; Emre Gorgun; Christoph Justinger; Elise H Lawson; David J Leaper; Najjia N Mahmoud; Christopher Mantyh; Michael F McGee; Valentine Nfonsam; Ines Rubio-Perez; Elizabeth C Wick; Traci L Hedrick Journal: J Am Coll Surg Date: 2022-01-01 Impact factor: 6.532
Authors: Hussameldin M Nour; Amiya Ahsan; Dimitra V Peristeri; Samuelson E Osifo; Mr Krishna K Singh; Mr Muhammad S Sajid Journal: Ann Med Surg (Lond) Date: 2022-09-15