Clinical trial NCT06633588: Decolonization Efficacy of Polyhexanide vs. Mupirocin
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Staphylococcus Aureus
Colonization, Asymptomatic
Keywords: Staphylococcus aureus colonization
Spinal surgery
decolonization
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2024-10-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: randomization rate
timeFrame: at study completion, an average of 2 years.
Secondary outcomes:
measure: positive screening rate
timeFrame: at study completion, an average of 2 years
measure: recruitment rate
timeFrame: at study completion, an average of 2 years
measure: retention rate
timeFrame: at study completion, an average of 2 years
measure: adherence rate
timeFrame: at study completion, an average of 2 years
measure: trial burden
timeFrame: from start of treatment until last visit, up to 10 days
measure: tolerability of decolonization regimen
timeFrame: day 5 of treatment
measure: burden caused by side effects
timeFrame: day 5 of treatment
measure: willingness to participate in future main trial
timeFrame: from start of treatment until last visit, up to 10 days
measure: Staphylococcus aureus colonization
timeFrame: pre-treatment (-30days to -10days before surgery), post-treatment (first day after treatment), the day of discharge (within 3 to 5 days after treatment)
measure: The rate of mupirocin or oxacillin resistance
timeFrame: pre-treatment (-30days to -10 days before surgery)
measure: The rate of treatment side effects
timeFrame: day 1-5 of treatment]
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Centre
state: Lucerne
Study officials:
References: