Randomized controlled trial of olanexidine gluconate and povidone iodine for surgical site infection after gastrointestinal surgery

Abstract

Aim

Antiseptics used at surgical sites are vital to preventing surgical site infections (SSI). In this study, a comparative investigation of the novel antiseptics olanexidine gluconate (OG) and povidone-iodine (PI) was conducted to determine whether OG is more effective than PI against SSI after gastrointestinal surgery.

Methods

This prospective, randomized, single-blind, interventional, single-center study was conducted between August 2018 and February 2021. Patients scheduled for large-scale gastrointestinal surgeries were randomized into two groups and administered OG (OG group) or PI (PI group) as preoperative antiseptics. The primary endpoint was the SSI occurrence rate within 30 days after surgery.

Results

In total, 525 patients were enrolled in this study, of whom 256 and 254 were in the OG and PI groups, respectively. The total SSI occurrence rate in the OG group (10.8%; n = 26) and the PI group (13.0%; n = 33) was not significantly different (p = 0.335). The occurrence rate of superficial incisional SSI and organ/space SSI did not significantly differ between the groups; however, that of deep incisional SSI showed a significant difference, with 0.4% (n = 1) in the OG group and 4.3% (n = 11) in the PI group (p = 0.003).

Conclusion

OG, as a preoperative skin antiseptic, did not reduce the occurrence rate of total SSI. However, deep incisional SSI may be reduced using OG.