RecruitingPhase 4NCT06633588

Decolonization Efficacy of Polyhexanide vs. Mupirocin

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


Sponsor

Swiss Paraplegic Research, Nottwil

Enrollment

24 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • Age over 18 years
  • Scheduled for elective spinal surgery
  • Colonized with Staphylococcus aureus
  • Informed consent provided

Exclusion Criteria7

  • 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

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Interventions

DRUGPolyhexanide

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

DRUGMupirocin and Chlorhexidine

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


Locations(1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, Switzerland

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NCT06633588


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