Decolonization Efficacy of Polyhexanide vs. Mupirocin

NCT06633588 — Phase 4, Completed, 24 participants, Swiss Paraplegic Research, Nottwil

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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

Registry	NCT06633588, acronym SPADE
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: single, prevention
Enrollment	24 (Actual)
Sponsor	Swiss Paraplegic Research, Nottwil (Network)
Conditions	Staphylococcus Aureus, Colonization, Asymptomatic
Interventions	Polyhexanide, Mupirocin and Chlorhexidine (Drug)
Dates	start 2025-05-01, primary completion 2026-06-30, completion 2026-06-30, first posted 2024-10-09, last updated 2026-07-08
Locations	1 site in Switzerland

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Polyhexanide	Experimental	Drug: Polyhexanide
Mupirocin and Chlorhexidine	Active comparator	Drug: Mupirocin and Chlorhexidine

Polyhexanide (Drug), also known as Prontoderm® Nasal Gel, Prontoderm® Foam: Participants will apply Prontoderm® Nasal Gel and perform whole-body wash with Prontoderm® Foam daily for 5 days before surgery.
Mupirocin and Chlorhexidine (Drug), also known as Bactroban® Nasal Ointment, Lifo-Scrub®: Participants will apply Bactroban® Nasal ointment and perform whole-body wash with Lifo-Scrub® daily for 5 days before surgery.

+Outcome measures

Primary outcomes

randomization rate [at study completion, an average of 2 years.]: proportion of enrolled patients who were randomized

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Swiss Paraplegic Centre	Nottwil, Canton of Lucerne	Switzerland