Actively Recruiting
Decolonization Efficacy of Polyhexanide vs. Mupirocin
Led by Swiss Paraplegic Research, Nottwil · Updated on 2025-05-28
24
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Decolonization Efficacy of Polyhexanide vs. Mupirocin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Scheduled for elective spinal surgery
- Colonized with Staphylococcus aureus
- Informed consent provided
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, Switzerland, 6207
Actively Recruiting
Research Team
R
Rami Sommerstein, Prof. Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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