General Decolonization With Octenisan® Set Before Elective Orthopedic Surgery

The general decolonization of the human body surface and, of adjacent pathogen reservoirssuch as the nose, by industrial antiseptic agents by the World Health Organization (WHO)for the risk reduction of superficial and deep surgical site infection (SSI). Such adecolonization is regarded as evidence‐based in the majority of randomized, andbefore‐after trials, since two decades, although negative studies also exist.In the orthopedic field, this decolonization is likely to be more effective in electivepatients with a proven body colonization of Staphylococcus aureus. The decolonizationmight be equally efeective in orthopedic patients with an inherent high risk for SSI, forwhich the majority of future SSI pathogens are skin commensals and S. aureus. These(eventual and future) pathogens of SSI are accessible to the topical agents during theindex surgery, if the patients are well instructed and know how to decolonize themselves.In contrast, this pre‐surgical decolonization is only a supplementary measure in thebundle of all combined efforts to prevent revision surgery for infection. Its individualpower is limited for young, healthy individuals, for SSIs caused by pathogens from theinternal body sites (intestinal, urinary, gynecologic regions), infections acquired onthe surgical ward, and in settings with less specialized surgeries and a low volume ofsurgical experience. Hence, in trials including all patients (or only those carrying S.aureus), the beneficial effect of decolonization can be diluted and provoke an additionalcostly and cumber‐some organizational procedure for the majority of patients with low tomoderate SSI risks.Moreover, many surgical site infections in orthopedic surgery, especially inimplant‐related surgery, are more due to coagulase‐negative staphylococci (CoNS) than forS. aureus.The hallmark of the CoNS group is S. epidermidis with approximatively 70% resistance (inSwitzerland) to standard prophylactic antibiotic agents9, As S. epidermidis is part ofthe normal human flora, typically the skin flora, and, only becomes pathogenic undercertain conditions, a screening for this microorganism is not feasible in commonpractice,. while the prophylaxis‐resistant part of all orthopedic SSI pathogens is at30‐50%.In this single‐center, prospective, randomized, and controlled superiority trial, whichis planned over a period of two years, we target on an orthopedic patient population withan elevated risk for revision sur‐gery and SSI; inde‐pendently of a known body carriagefor S. aureus.This study will be performed with an existing "set" manufactured by Schülke & Mayr GmbH.The "Set" was placed on the market in 2016. The distribution of Octenisan® wash lotionand Octenisan® nasal gel in the form of a set (Octenisan® Set) largely streamlines andfacilitates the organizational application and compliance efforts of the study.Academically and clinically, we will gain insight in the performance of decolonizationfor a patient population at particular risk of postoperative complications, where everyeffort to prevent infection is of importance.