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Completed

NCT Number: NCT06633588

Decolonization Efficacy of Polyhexanide vs. Mupirocin

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.

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Key information

Conditions

Staphylococcus Aureus Asymptomatic Diseases Asymptomatic Infections Bacterial Infections Bacterial Infections and Mycoses Colonization, Asymptomatic Disease Attributes Gram-Positive Bacterial Infections Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Staphylococcal Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polyhexanide

Drug

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

Mupirocin and Chlorhexidine

Drug

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®

Primary outcomes

  1. randomization rate

    Time frame: at study completion, an average of 2 years.

    proportion of enrolled patients who were randomized

Secondary outcomes

  1. positive screening rate

    Time frame: at study completion, an average of 2 years

    proportion of screened patients who were eligible

  2. recruitment rate

    Time frame: at study completion, an average of 2 years

    proportion of eligible patients who were enrolled

  3. retention rate

    Time frame: at study completion, an average of 2 years

    treatment-specific proportion of participants remaining in the trial

  4. adherence rate

    Time frame: at study completion, an average of 2 years

    treatment-specific proportion of participants completing the treatment

  5. trial burden

    Time frame: from start of treatment until last visit, up to 10 days

    NRS ranging from 0 - no burden to 10 very burdensome

  6. tolerability of decolonization regimen

    Time frame: day 5 of treatment

    NRS ranging from 0 - well tolerable to 10 not tolerable

  7. burden caused by side effects

    Time frame: day 5 of treatment

    numeric rating scale (NRS) ranging from 0 - no burden to 10 very burdensome

  8. willingness to participate in future main trial

    Time frame: from start of treatment until last visit, up to 10 days

    NRS ranging from 0 - very unlikely to 10 very likely

  9. Staphylococcus aureus colonization

    Time frame: pre-treatment (-30days to -10days before surgery), post-treatment (first day after treatment), the day of discharge (within 3 to 5 days after treatment)

    Staphylococcus aureus colony-forming units grown in cultures from nasal and skin swabs

  10. The rate of mupirocin or oxacillin resistance

    Time frame: pre-treatment (-30days to -10 days before surgery)

    Proportion of Isolated Staphylococcus aureus Strains with Mupirocin or Oxacillin Resistance

  11. The rate of treatment side effects

    Time frame: day 1-5 of treatment]

    signs and symptoms during treatment

Sponsors and collaborators

Lead sponsor

Swiss Paraplegic Research, Nottwil

Network

Registry information

Official study title

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

Acronym: SPADE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 9, 2024
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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