Decolonization Efficacy of Polyhexanide vs. Mupirocin (SPADE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Staphylococcus Aureus; Colonization, Asymptomatic
• Intervention / Treatment: Drug: Polyhexanide; Drug: Mupirocin and Chlorhexidine

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Rami Sommerstein, Prof. Dr.; Phone Number: +41 412083254; Email: rami.sommerstein@unilu.ch

Study Locations

• Switzerland
  • Lucerne
    • Nottwil, Lucerne, Switzerland, 6207
      • Recruiting
      • Swiss Paraplegic Centre
      • Contact: Rami Sommerstein, Prof. Dr.; Phone Number: +41 412083254; Email: rami.sommerstein@unilu.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Polyhexanide	Drug: Polyhexanide; Participants will apply Prontoderm® Nasal Gel and perform whole-body wash with Prontoderm® Foam daily for 5 days before surgery.; Other Names: Prontoderm® Nasal Gel, Prontoderm® Foam
Active Comparator: Mupirocin and Chlorhexidine	Drug: Mupirocin and Chlorhexidine; Participants will apply Bactroban® Nasal ointment and perform whole-body wash with Lifo-Scrub® daily for 5 days before surgery.; Other Names: Bactroban® Nasal Ointment, Lifo-Scrub®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
randomization rate	proportion of enrolled patients who were randomized	at study completion, an average of 2 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
positive screening rate	proportion of screened patients who were eligible	at study completion, an average of 2 years
recruitment rate	proportion of eligible patients who were enrolled	at study completion, an average of 2 years
retention rate	treatment-specific proportion of participants remaining in the trial	at study completion, an average of 2 years
adherence rate	treatment-specific proportion of participants completing the treatment	at study completion, an average of 2 years
trial burden	NRS ranging from 0 - no burden to 10 very burdensome	from start of treatment until last visit, up to 10 days
tolerability of decolonization regimen	NRS ranging from 0 - well tolerable to 10 not tolerable	day 5 of treatment
burden caused by side effects	numeric rating scale (NRS) ranging from 0 - no burden to 10 very burdensome	day 5 of treatment
willingness to participate in future main trial	NRS ranging from 0 - very unlikely to 10 very likely	from start of treatment until last visit, up to 10 days
Staphylococcus aureus colonization	Staphylococcus aureus colony-forming units grown in cultures from nasal and skin swabs	pre-treatment (-30days to -10days before surgery), post-treatment (first day after treatment), the day of discharge (within 3 to 5 days after treatment)
The rate of mupirocin or oxacillin resistance	Proportion of Isolated Staphylococcus aureus Strains with Mupirocin or Oxacillin Resistance	pre-treatment (-30days to -10 days before surgery)
The rate of treatment side effects	signs and symptoms during treatment	day 1-5 of treatment]

Collaborators and Investigators

• Sponsor: Swiss Paraplegic Research, Nottwil

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: October 8, 2024
• First Posted (Actual): October 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2025
• Last Update Submitted That Met QC Criteria: May 21, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Staphylococcus aureus colonization; Spinal surgery; decolonization
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Asymptomatic Diseases; Staphylococcal Infections; Asymptomatic Infections; Anti-Bacterial Agents; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Synthesis Inhibitors; Anti-Infective Agents, Local; Disinfectants; Chlorhexidine; Mupirocin; Polihexanide
• Other Study ID Numbers: 2024-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No