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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
24
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.
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, Switzerland
RECRUITINGrandomization rate
proportion of enrolled patients who were randomized
Time frame: at study completion, an average of 2 years.
positive screening rate
proportion of screened patients who were eligible
Time frame: at study completion, an average of 2 years
recruitment rate
proportion of eligible patients who were enrolled
Time frame: at study completion, an average of 2 years
retention rate
treatment-specific proportion of participants remaining in the trial
Time frame: at study completion, an average of 2 years
adherence rate
treatment-specific proportion of participants completing the treatment
Time frame: at study completion, an average of 2 years
trial burden
NRS ranging from 0 - no burden to 10 very burdensome
Time frame: from start of treatment until last visit, up to 10 days
tolerability of decolonization regimen
NRS ranging from 0 - well tolerable to 10 not tolerable
Time frame: day 5 of treatment
burden caused by side effects
numeric rating scale (NRS) ranging from 0 - no burden to 10 very burdensome
Time frame: day 5 of treatment
willingness to participate in future main trial
NRS ranging from 0 - very unlikely to 10 very likely
Time frame: from start of treatment until last visit, up to 10 days
Staphylococcus aureus colonization
Staphylococcus aureus colony-forming units grown in cultures from nasal and skin swabs
Time frame: pre-treatment (-30days to -10days before surgery), post-treatment (first day after treatment), the day of discharge (within 3 to 5 days after treatment)
The rate of mupirocin or oxacillin resistance
Proportion of Isolated Staphylococcus aureus Strains with Mupirocin or Oxacillin Resistance
Time frame: pre-treatment (-30days to -10 days before surgery)
The rate of treatment side effects
signs and symptoms during treatment
Time frame: day 1-5 of treatment]
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