Bathing with 2% chlorhexidine gluconate versus routine care for preventing surgical site infections after pancreatic surgery: a single centre randomised controlled trial.

Abstract

Objectives: 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 randomised 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 randomised 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 (311, intervention arm; 303, control arm) were included in intention-to-treat (ITT) analysis. 8.8% (54/614) patients developed SSI. The incidence of SSI in 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 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 (PP) 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).

Conclusions: Bathing with 2% chlorhexidine gluconate could potentially reduce the incidence of SSI for the patients scheduled to undergo pancreatic surgery which further well-designed clinical trials are warranted.