Decolonization Efficacy of Polyhexanide vs. Mupirocin
Surgical Prophylaxis: Assessing Decolonization Efficacy of Polyhexanide Versus Mupirocin and Chlorhexidine in Decolonizing Staphylococcus Aureus Preoperatively in Elective Spine Surgery (SPADE): A Pilot Randomized Controlled Trial
Swiss Paraplegic Research, Nottwil
24 participants
May 1, 2025
INTERVENTIONAL
Conditions
Summary
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 Criteria4
- Age over 18 years
- Scheduled for elective spinal surgery
- Colonized with Staphylococcus aureus
- Informed consent provided
Exclusion Criteria7
- 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
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Interventions
Participants will apply Prontoderm® Nasal Gel and perform whole-body wash with Prontoderm® Foam daily for 5 days before surgery.
Participants will apply Bactroban® Nasal ointment and perform whole-body wash with Lifo-Scrub® daily for 5 days before surgery.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06633588