Clinical study of a new skin antiseptic olanexidine gluconate in gastrointestinal cancer surgery

Abstract

Background Surgical site infection (SSI) is a common complication of gastrointestinal surgery. Olanexidine gluconate (OLG) is a novel skin antiseptic that is effective against a wide range of bacteria. The purpose of this study was to evaluate the bactericidal efficacy of OLG in gastrointestinal cancer surgery. Methods This retrospective study included a total of 281 patients who underwent gastrointestinal cancer surgery (stomach or colon). The patients were divided into two groups: 223 patients were treated with OLG (OLG group), and 58 patients were treated with povidone-iodine (PVP-I) (control group). The efficacy and safety outcomes were measured as the rate of SSI within 30 days after surgery. In addition, we conducted subgroup analyses according to the surgical approach (open or laparoscopic) or primary lesion (stomach or colon). Results There was a significant difference in the rate of SSI between the control group and OLG group (10.3% vs. 2.7%; p = 0.02). There was a significant difference in the SSI rate in terms of superficial infection (8.6% vs. 2.2%; p = 0.0345) but not in deep infection (1.7% vs. 0.5%; p = 0.371). There was no significant difference between the control group and OLG group in the overall rate of adverse skin reactions (5.2% vs. 1.8%; p = 0.157). Conclusion This retrospective study demonstrates that OLG is more effective than PVP-I in preventing SSI during gastrointestinal cancer surgery.

Comparison of olanexidine versus povidone‐iodine as a preoperative antiseptic for reducing surgical site infection in both scheduled and emergency gastrointestinal surgeries: A single‐center randomized clinical trial

“…7 In contrast, Kubo et al could not demonstrate an additional effect of the laparoscopic approach in the 1.5% olanexidine group (effect size 0.636, 95% confidence interval: 0.138-2.930, p = 0.562). 11 Our study also could not demonstrate the advantage of laparoscopic surgery (12.3% vs. 11.6%, adjusted risk ratio: 1.054, 95% confidence interval: 0.652-1.704); however, some reasons can explain this result: (1) We enrolled patients undergoing surgical procedures with intestinal resection. (2) We enrolled patients with operative wound class III and IV surgeries.…”

“…Obara et al reported that the laparoscopic approach significantly decreased SSI incidence in the 1.5% olanexidine group (4% vs. 12%, adjusted risk ratio: 0.35, 95% confidence interval: 0.17–0.74) 7 . In contrast, Kubo et al could not demonstrate an additional effect of the laparoscopic approach in the 1.5% olanexidine group (effect size 0.636, 95% confidence interval: 0.138–2.930, p = 0.562) 11 . Our study also could not demonstrate the advantage of laparoscopic surgery (12.3% vs. 11.6%, adjusted risk ratio: 1.054, 95% confidence interval: 0.652–1.704); however, some reasons can explain this result: (1) We enrolled patients undergoing surgical procedures with intestinal resection.…”

“…In 2020, Obara et al conducted a multicenter, randomized, controlled trial in clean–contaminated (class II) gastrointestinal and hepatobiliary‐pancreatic surgeries and found a significant difference between 1.5% olanxidine and 10% povidone‐iodine 7 . In 2022, Kubo et al also reported a single‐center retrospective study of stomach and colon cancer surgeries and found that 1.5% olanexidine is superior in the prevention of overall (2.7% vs. 10.3%, p = 0.020) and superficial incisional SSI (2.2% vs. 8.6%, p = 0.034) incidences compared with that in 10% povidone‐iodine 11 . In contrast, two negative propensity score matching studies regarding olanexidine have been conducted; Kojima et al found no significant difference in SSI incidence in patients undergoing colorectal surgery compared with to 10% povidone‐iodine (8.6% vs. 8.6%, p = 1.000) 9 .…”

“…In addition, some prospective and retrospective comparative studies have been conducted on gastrointestinal surgery. [7][8][9][10][11] However, the indications of all studies are limited to clean-contaminated (operative wound class II) gastrointestinal surgery. To clarify the true superiority of 1.5% olanexidine, we conducted a randomized prospective clinical trial to enroll patients undergoing gastrointestinal surgery with operative wound classes II-IV, including emergency surgery.…”

“…Recently, 1.5% olanexidine (Olanedine; Otsuka Pharmatceutical Factory, Tokushima, Japan) has been commercially available as a preoperative antiseptic in Japan. In addition, some prospective and retrospective comparative studies have been conducted on gastrointestinal surgery 7–11 . However, the indications of all studies are limited to clean–contaminated (operative wound class II) gastrointestinal surgery.…”