About this trial
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 criteria
Qualifiers
Age over 18 years
Scheduled for elective spinal surgery
Colonized with Staphylococcus aureus
Informed consent provided
Disqualifiers
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
Trial design
Treatments tested in this trial
- Polyhexanide
- Mupirocin and Chlorhexidine