Olanexidine, a New Antiseptic Produced Domestically in Japan, Shown to Halve the Occurrence of Surgical Site Infections in Randomized Controlled Trial
June 16, 2020 Keio University School of Medicine
A research team at the Keio University School of Medicine has demonstrated that olanexidine, a new antiseptic produced domestically in Japan, can significantly reduce the occurrence of surgical site infection (SSI) and superficial incisional SSI. Olanexidine was proven to outperform aqueous povidone-iodine, an antiseptic that is currently in wide use at clean-contaminated surgical sites in Japan. The team was led by Associate Professor Hideaki Obara, Assistant Professor Masashi Takeuchi, and Professor Yuko Kitagawa of the Department of Surgery.
Surgical site infections (SSI) are one of the most common types of post-surgical infection. SSI can cause post-operative death and can lead to patient distress, including prolonged hospitalization and impaired cosmetic outcomes as well as an increase in health-care costs. SSI is reported to occur in ten to thirty percent of all gastrointestinal and hepatobiliary pancreatic surgeries.
The most basic and important measure to reduce the risk of SSI is to perform skin antisepsis with an antiseptic at the incision site immediately ahead of surgery. For more than half a century, doctors in Japan have mainly used iodine-based disinfectants for skin antisepsis. Still, in recent years, there has been an increase in reports of SSI caused by antibiotic-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococcus (VRE). This means that there is a real need for the development of new disinfectants that can protect against antibiotic-resistant bacteria such as these.
This new antiseptic, Olanedine® Antiseptic Solution 1.5% OR, was developed by Otsuka Pharmaceutical Factory in Tokushima, Japan, and has been commercially available in Japan since 2015. Its main ingredient is olanexidine gluconate, which has a significant effect on preventing the growth of antibiotic-resistant bacterias like those mentioned above.
This clinical trial was conducted between June 10, 2018, and April 18, 2019. Of the 883 patients that were assessed, 587 patients were deemed to be eligible, and ahead of surgery, 294 received olanexidine, with the other 293 receiving aqueous povidone-iodine. Within thirty days following surgery, SSI occurred in 19 (6.5%) of the olanexidine group patients, less than half of the 39 cases (13.3%) that occurred in the povidone-iodine group.
The findings can be applied not only to the field of gastroenterological surgery but also to surgery and treatment in other fields of medicine and are expected to contribute to SSI management for a wide range of surgical patients by providing new SSI prevention procedures and could potentially lead to reduced medical costs.
The results of this research were published in the electronic version of the British international medical journal, The Lancet Infectious Diseases, on June 15 (BST).