Comparing two methods to reduce Staphylococcus aureus before spine surgery
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
This study is testing if a new cleaning method called polyhexanide can better reduce Staphylococcus aureus in patients before spine surgery compared to the usual treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Swiss Paraplegic Research, Nottwil Research network |
| Locations | 1 site (Nottwil, Canton of Lucerne) |
| Trial ID | NCT06633588 on ClinicalTrials.gov |
What this trial studies
This pilot randomized controlled trial evaluates the effectiveness of polyhexanide compared to the standard mupirocin and chlorhexidine regimen for decolonizing Staphylococcus aureus in patients scheduled for elective spine surgery. The study involves 24 participants who are randomly assigned to receive either polyhexanide or the standard treatment. The primary focus is on the randomization rate, while secondary outcomes include tolerability and the reduction of S. aureus colony-forming units (CFUs) as well as changes in the microbiome. This approach aims to determine the feasibility and preliminary efficacy of polyhexanide in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are scheduled for elective spinal surgery and are colonized with Staphylococcus aureus.
Not a fit: Patients undergoing emergency spine surgery or those with MRSA or mupirocin-resistant S. aureus will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective decolonization method, potentially reducing infection rates in spinal surgery patients.
How similar studies have performed: Other studies have explored decolonization methods, but this specific comparison of polyhexanide versus mupirocin is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nottwil, Canton of Lucerne
- Swiss Paraplegic Centre — Nottwil, Canton of Lucerne, Switzerland (Recruiting)
Study contacts
- Study coordinator: Rami Sommerstein, Prof. Dr.
- Email: rami.sommerstein@unilu.ch
- Phone: +41 412083254
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.