|Beitragstitel||Preoperative decolonization and surgical site infections - a prospective randomized trial (DECO-SSI trial)|
Background: Surgical site infections (SSI) are major postoperative complications and mostly due to patient's endogenous germs like Staphylococcus aureus. These infections are a future health care challenge, especially in orthopaedic surgery where the number of periprosthetic joint infections increases with rising numbers of implants and multimorbid patients. Preoperative decolonization procedures showed an overall trend in lowering SSI, but in orthopaedic surgery randomized controlled trials and evidence-based consensus about decolonization procedures are lacking.
Design: In our controlled prospective randomized single-blind trial we assess primarily the effect of preoperative decolonization of nasal Staph. aureus carriers in patients undergoing an elective orthopaedic surgery. Also, in a non-Staph. aureus carrier group we will study the effect of preoperative skin decolonization. Number of SSI in all study arms will be monitored.
Methods: 2700 patients aged >16 years undergoing an elective orthopaedic surgery in a primary care hospital are screened before surgery for nasal Staph. aureus carriage. Carriers are randomized into control and intervention arms. Intervention consists of a 5-day course with daily chlorhexidine sol 4% showers and twice daily mupirocin 2% nasal ointment application. The non-carrier group is also randomized into control and intervention arms. Intervention consists of a 5-day course with daily chlorhexidine sol 4% showers only. In both, primary outcome is overall incidence of SSI at 3 months. Secondary outcome is early (1 month) and late (3 months) SSI. Tertiary, total screening costs will be surveyed.
Results: To date we have performed 897 nose swabs. Interestingly, we note a high carrier rate with 35% of patients testing positive for Staph. aureus. Only one case among the 897 patients had MRSA carriage. In summer 2017 we expect to perform the interim analysis. The final analysis is scheduled in December 2018.
Conclusion: Prevalence of Staph. aureus carriers in the region of Bern is higher than elsewhere if compared to current literature. Reasons for this local high prevalence and its impact on the occurrence of SSI need to be studied further. The DECO-SSI trial is the largest prospective ongoing trial to date to investigate decolonization and the incidence of SSI in a heterogeneous population of orthopaedic patients. We would like to present our study protocol, characteristics of carriers and non-carriers and preliminary results.