2020/06/16
Keio University School of Medicine
A group led by Associate Professor Hideaki Ohara, Assistant Professor Yuji Takeuchi, and Professor Yuko Kitagawa from the Department of Surgery (General and Gastroenterological) at the Keio University School of Medicine has revealed in an investigator-initiated, prospective, randomized controlled trial that "Olanexidine," a surgical site antiseptic developed in Japan, halves the risk of surgical site infections compared to the iodine-based antiseptics currently widely used in the country.
Surgical site infection (SSI) occurs after surgery and is one of the most common complications that can arise with any surgical procedure. It can also cause postoperative mortality and leads to patient suffering, such as prolonged hospital stays and cosmetic damage, as well as increased medical costs. In the field of gastrointestinal surgery, including procedures for stomach, colorectal, and liver cancer, SSIs are reported to occur in approximately one in ten patients.
The most fundamental and important measure against SSIs is the disinfection of the skin at the incision site immediately before surgery. In Japan, iodine-based antiseptics have been the primary skin antiseptics used for over half a century. However, in recent years, there have been reports of SSIs caused by bacteria resistant to conventional antiseptics, such as methicillin-resistant *Staphylococcus aureus* (MRSA) and vancomycin-resistant enterococci (VRE), creating a need for the development of new surgical site antiseptics that are also effective against these pathogens.
Olanexidine antiseptic was developed by Otsuka Pharmaceutical Factory, Inc., and launched in 2015 as a new antiseptic. It has potent and rapid bactericidal activity, even against the resistant bacteria mentioned above. This clinical trial revealed that the incidence of SSIs within 30 days post-surgery was 39 out of 293 cases (13.3%) in the group using an iodine-based antiseptic, compared to 19 out of 294 cases (6.5%) in the group using Olanexidine antiseptic, a reduction of about half.
These findings are applicable not only to the field of gastrointestinal surgery but also to surgical and medical procedures across all specialties, and are expected to benefit many patients in clinical practice. Moreover, by providing a simple way to reduce SSIs, it is also expected to help curb medical costs. This study has successfully disseminated new evidence for SSI prevention from Japan to the rest of the world.
This research was published in the online edition of the British international medical journal "The Lancet Infectious Diseases" on June 15 (UK time).
Please see below for the full press release.