Decolonization Efficacy of Polyhexanide vs. Mupirocin

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorSwiss Paraplegic Research, Nottwil

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

Treatment groups

24 Participants
are divided into 2 treatment groups