Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2025
Bathing with 2% chlorhexidine gluconate versus routine care for preventing surgical site infections after pancreatic surgery: a single-centre randomized controlled trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Chen Wen-Sen, Lin Jian-Zhen, Zhang Kai, Fang Xiao-Ping, Wang Rong, Sun Qing-Mei, Yu Hui-Ping, Feng Xu, Li Zhan-Jie, Yang Yue, Zhu Qing-Tang, Zang Feng, Jiang Kui-Rong, Zhuang Gui-Hua
Аннотация
OBJECTIVES: The study aims to investigate whether bathing with 2% chlorhexidine gluconate (CHG) reduces the incidence of surgical site infection (SSI) in patients undergoing routine pancreatic surgery.
METHODS: A randomized controlled trial was conducted at a large-volume pancreatic centre between 1 January 2021 and 31 December 2022. Patients undergoing clean-contaminated pancreatic surgery were enrolled and randomized into an intervention arm (bathing with a 2% CHG wipe) and a control arm (routine care, soap, and water). The primary outcome was the incidence of SSI after pancreatic surgery within 30 days.
RESULTS: Overall, 614 patients (intervention arm, 311; control arm, 303) were included in intention-to-treat analysis. In total, 8.8% (54/614) patients developed SSI. The incidence of SSI in the intervention arm was 6.8% (21/311) and 10.9% (33/303) in control arm, and the difference did not reach the level of statistical significance (p 0.070). The time to SSI was significantly extended when patients were in the intervention arm (log-rank test, p 0.047). The intervention did not significantly reduce the incidence of healthcare-associated infection, hospital-acquired pneumonia, and bloodstream infection. No adverse events were observed. However, in the per-protocol analysis among 519 patients, the intervention arm showed a significantly lower incidence of overall SSI than that of those in the control arm (21/272, 7.7% vs. 33/242, 13.4%, p 0.036).
DISCUSSION: Bathing with 2% CHG could potentially reduce the incidence of SSI for the patients scheduled to undergo pancreatic surgery for which further well-designed clinical trials are warranted.
METHODS: A randomized controlled trial was conducted at a large-volume pancreatic centre between 1 January 2021 and 31 December 2022. Patients undergoing clean-contaminated pancreatic surgery were enrolled and randomized into an intervention arm (bathing with a 2% CHG wipe) and a control arm (routine care, soap, and water). The primary outcome was the incidence of SSI after pancreatic surgery within 30 days.
RESULTS: Overall, 614 patients (intervention arm, 311; control arm, 303) were included in intention-to-treat analysis. In total, 8.8% (54/614) patients developed SSI. The incidence of SSI in the intervention arm was 6.8% (21/311) and 10.9% (33/303) in control arm, and the difference did not reach the level of statistical significance (p 0.070). The time to SSI was significantly extended when patients were in the intervention arm (log-rank test, p 0.047). The intervention did not significantly reduce the incidence of healthcare-associated infection, hospital-acquired pneumonia, and bloodstream infection. No adverse events were observed. However, in the per-protocol analysis among 519 patients, the intervention arm showed a significantly lower incidence of overall SSI than that of those in the control arm (21/272, 7.7% vs. 33/242, 13.4%, p 0.036).
DISCUSSION: Bathing with 2% CHG could potentially reduce the incidence of SSI for the patients scheduled to undergo pancreatic surgery for which further well-designed clinical trials are warranted.