Overview

This pilot randomized controlled trial evaluates the feasibility, tolerability, and preliminary efficacy of a decolonization regimen using polyhexanide in reducing Staphylococcus aureus colonization in the preoperative phase of elective spine surgery, compared to the standard mupirocin and chlorhexidine regimen. The trial involves 24 participants randomized into two groups: one receiving polyhexanide and the other receiving mupirocin and chlorhexidine. The primary outcome is the randomization rate, with secondary outcomes including other feasibility outcomes, tolerability, and efficacy measures such as the reduction in S. aureus colony-forming units (CFUs) and changes in the nasal and skin microbiome composition.

Eligibility

Inclusion Criteria:

• Age over 18 years
• Scheduled for elective spinal surgery
• Colonized with Staphylococcus aureus
• Informed consent provided

Exclusion Criteria:

• Emergency spine surgery
• Methicillin-resistant Staphylococcus aureus (MRSA) or mupirocin-resistant S. aureus
• Known allergies to products used in the trial
• Pregnant or breastfeeding women
• Recent antibiotic therapy (within 14 days)
• Known non-compliance, substance abuse, or psychological disorders
• Participation in another antimicrobial trial within the last 30 days