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Decolonization Efficacy of Polyhexanide vs. Mupirocin

NCT06633588 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-05-28

No results posted yet for this study

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.

Conditions

  • Staphylococcus Aureus
  • Colonization, Asymptomatic

Interventions

DRUG

Polyhexanide

Participants will apply Prontoderm® Nasal Gel and perform whole-body wash with Prontoderm® Foam daily for 5 days before surgery.

DRUG

Mupirocin and Chlorhexidine

Participants will apply Bactroban® Nasal ointment and perform whole-body wash with Lifo-Scrub® daily for 5 days before surgery.

Sponsors & Collaborators

  • Swiss Paraplegic Research, Nottwil

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2027-03-30
Completion
2027-04-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06633588 on ClinicalTrials.gov