Decolonization Efficacy of Polyhexanide vs. Mupirocin (SPADE)

Swiss Paraplegic Research, Nottwil

Status and phase

Enrolling

Phase 4

Conditions

Colonization, Asymptomatic

Staphylococcus Aureus

Treatments

Drug: Polyhexanide

Drug: Mupirocin and Chlorhexidine

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT06633588

2024-08

Details and patient eligibility

About

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.

Enrollment

24 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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