Effect of Staphylococcus aureus’ decolonization on the incidence of surgical site infection in non-elective trauma and orthopedic surgery: a phase III multicenter randomized clinical trial

Abstract

BACKGROUND: Staphylococcal aureus is both a human commensal and a frequent cause of clinically important infections. It is a colonizer of the skin and mucosa, being present in the anterior nostrils of up to 30-50% of the healthy human population. There are certain conditions that predispose to a greater risk of developing an invasion with the subsequent infection by this microorganism. One of these well-known conditions is to undergo an orthopaedic surgery. Although there are many studies about the clear benefit of pre-surgical Staphylococcal aureus decolonization in patients undergoing elective orthopaedic surgery in the reduction of surgical site infection related to this microorganism, there are few studies focused on the application of a decolonization protocol in non-elective surgeries, with the subsequent shorter pre-surgical treatment regimen. OBJECTIVE: to demonstrate that the detection of a Staphylococcus aureus’ carrier state in patients undergoing non-elective surgery with their consequent decolonization, significantly reduces the risk of a surgical site infection due to this microorganism compared to those patients who only receive the standard pre-surgical antiseptic treatment. DESIGN: the study will be a multicentre, longitudinal, prospective, double-blind, randomized and controlled clinical trial. It will be carried out in 6 hospitals of Girona’s province. Hospital Santa Caterina will be the coordinator centre. INTERVENTION AND METHODS: the subjects of the study will be those patients who must be operated (in a non-elective trauma and orthopaedic surgery) due to a third proximal femoral fracture, and with the condition of being Staphylococcus aureus’ nasal carriers. They will be randomly divided into two groups: group A (n = 125), patients will be treated with the standard pre-surgical antiseptic therapy plus concomitant Staphylococcal aureus’ decolonization treatment (topical intranasal mupirocin with topical chlorhexidine shower); in group B (n = 125), patients will receive the same standard antiseptic scheme plus concomitant placebo treatment. Recruitment of patients will last 12 months, with subsequent follow up of each patient for 12 months