Decolonization Efficacy of Polyhexanide Vs. Mupirocin
- Conditions
- Staphylococcus AureusColonization, Asymptomatic
- Interventions
- Registration Number
- NCT06633588
- Lead Sponsor
- Swiss Paraplegic Research, Nottwil
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 24
- Age over 18 years
- Scheduled for elective spinal surgery
- Colonized with Staphylococcus aureus
- Informed consent provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mupirocin and Chlorhexidine Mupirocin and Chlorhexidine - Polyhexanide Polyhexanide -
- Primary Outcome Measures
Name Time Method randomization rate at study completion, an average of 2 years. proportion of enrolled patients who were randomized
- Secondary Outcome Measures
Name Time Method positive screening rate at study completion, an average of 2 years proportion of screened patients who were eligible
recruitment rate at study completion, an average of 2 years proportion of eligible patients who were enrolled
retention rate at study completion, an average of 2 years treatment-specific proportion of participants remaining in the trial
adherence rate at study completion, an average of 2 years treatment-specific proportion of participants completing the treatment
trial burden from start of treatment until last visit, up to 10 days NRS ranging from 0 - no burden to 10 very burdensome
tolerability of decolonization regimen day 5 of treatment NRS ranging from 0 - well tolerable to 10 not tolerable
burden caused by side effects day 5 of treatment numeric rating scale (NRS) ranging from 0 - no burden to 10 very burdensome
willingness to participate in future main trial from start of treatment until last visit, up to 10 days NRS ranging from 0 - very unlikely to 10 very likely
Staphylococcus aureus colonization pre-treatment (-30days to -10days before surgery), post-treatment (first day after treatment), the day of discharge (within 3 to 5 days after treatment) Staphylococcus aureus colony-forming units grown in cultures from nasal and skin swabs
The rate of mupirocin or oxacillin resistance pre-treatment (-30days to -10 days before surgery) Proportion of Isolated Staphylococcus aureus Strains with Mupirocin or Oxacillin Resistance
The rate of treatment side effects day 1-5 of treatment] signs and symptoms during treatment
Trial Locations
- Locations (1)
Swiss Paraplegic Centre
🇨ðŸ‡Nottwil, Lucerne, Switzerland