Decolonization Efficacy of Polyhexanide vs. Mupirocin
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorSwiss Paraplegic Research, Nottwil
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age over 18 years
Scheduled for elective spinal surgery
Colonized with Staphylococcus aureus
Informed consent provided
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Polyhexanide
DrugParticipants will apply Prontoderm® Nasal Gel and perform whole-body wash with Prontoderm® Foam daily for 5 days before surgery.
Mupirocin and Chlorhexidine
DrugParticipants will apply Bactroban® Nasal ointment and perform whole-body wash with Lifo-Scrub® daily for 5 days before surgery.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: PolyhexanideExperimental treatment 1 intervention
Group B: Mupirocin and ChlorhexidineActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
randomization rate
proportion of enrolled patients who were randomized
Time frame
at study completion, an average of 2 years.Secondary outcomes
1
positive screening rate
proportion of screened patients who were eligible
Time frame
at study completion, an average of 2 years2
recruitment rate
proportion of eligible patients who were enrolled
Time frame
at study completion, an average of 2 years3
retention rate
treatment-specific proportion of participants remaining in the trial
Time frame
at study completion, an average of 2 years4
adherence rate
treatment-specific proportion of participants completing the treatment
Time frame
at study completion, an average of 2 yearsSponsors and contacts
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Source ClinicalTrials.gov