Colonization, Asymptomatic, Staphylococcus Aureus
Conditions
Keywords
Staphylococcus aureus colonization, Spinal surgery, decolonization
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.
Interventions
DRUGPolyhexanide
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.
Sponsors
Swiss Paraplegic Research, Nottwil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| randomization rate | at study completion, an average of 2 years. | proportion of enrolled patients who were randomized |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Switzerland
Outcome results
None listed