drugset / Trial / NCT06633588

Decolonization Efficacy of Polyhexanide vs. Mupirocin

NCT06633588

Phase 4 Completed 24 enrolled Swiss Paraplegic Research, Nottwil
RandomizedParallel-groupSingle-blindPrevention

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.

Timeline

Start
2025-05-01
Primary completion
2026-06-30
Completion
2026-06-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Chlorhexidine Small molecule Topical
Comparator Mupirocin Small molecule Topical
Subject Polihexanide Other / unclassified Topical