Staphylococcus AureusPhase 4SPADENCT06633588
Decolonization Efficacy of Polyhexanide vs. Mupirocin
A Phase 4 study testing Polyhexanide and Mupirocin and Chlorhexidine in people with Staphylococcus Aureus and Colonization, Asymptomatic, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcus Aureus, Colonization, Asymptomatic
- What is being tested?
- Polyhexanide and Mupirocin and Chlorhexidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2025to 30 Jun 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years
- Scheduled for elective spinal surgery
- Colonized with Staphylococcus aureus
- Informed consent provided
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, 6207
About this study
Official 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
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
- Being tested
- Polyhexanide, Mupirocin and Chlorhexidine
- Keywords
- Staphylococcus aureus colonization, Spinal surgery, decolonization
- Medical subject headings
- Staphylococcal Infections, Asymptomatic Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolyhexanideDrug
Also called 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 ChlorhexidineDrug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Polyhexanide | Experimental | Not described Receives: Drug: Polyhexanide |
| Mupirocin and Chlorhexidine | Active comparator | Not described Receives: Drug: Mupirocin and Chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
randomization rate
proportion of enrolled patients who were randomized
Measured: at study completion, an average of 2 years.
Secondary outcomes (11)
positive screening rate
proportion of screened patients who were eligible
Measured: at study completion, an average of 2 years
recruitment rate
proportion of eligible patients who were enrolled
Measured: at study completion, an average of 2 years
retention rate
treatment-specific proportion of participants remaining in the trial
Measured: at study completion, an average of 2 years
adherence rate
treatment-specific proportion of participants completing the treatment
Measured: at study completion, an average of 2 years
trial burden
NRS ranging from 0 - no burden to 10 very burdensome
Measured: 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
Measured: day 5 of treatment
burden caused by side effects
numeric rating scale (NRS) ranging from 0 - no burden to 10 very burdensome
Measured: day 5 of treatment
willingness to participate in future main trial
NRS ranging from 0 - very unlikely to 10 very likely
Measured: 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
Measured: 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
Measured: pre-treatment (-30days to -10 days before surgery)
The rate of treatment side effects
signs and symptoms during treatment
Measured: day 1-5 of treatment]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start1 May 2025
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus AureusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633588
- Sponsor's protocol ID
- 2024-08
- Acronym
- SPADE
- Status last verified
- Jul 2026
- First submitted
- 19 Sep 2024
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06633588
- Acronym / sponsor ID
- SPADE / 2024-08
- Conditions
- Staphylococcus Aureus, Colonization, Asymptomatic
- Keywords
- Staphylococcus aureus colonization, Spinal surgery, decolonization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polyhexanide | Experimental | Drug: Polyhexanide |
| Mupirocin and Chlorhexidine | Active comparator | Drug: Mupirocin and Chlorhexidine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 18 years
- Scheduled for elective spinal surgery
- Colonized with Staphylococcus aureus
- Informed consent provided
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolyhexanideAlso: Prontoderm® Nasal Gel, Prontoderm® FoamParticipants will apply Prontoderm® Nasal Gel and perform whole-body wash with Prontoderm® Foam daily for 5 days before surgery. | Drug | Polyhexanide |
| Mupirocin and ChlorhexidineAlso: 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. | Drug | Mupirocin and Chlorhexidine |
Primary outcome
randomization rate
Time frame: at study completion, an average of 2 years.
proportion of enrolled patients who were randomized
11 secondary outcomes
positive screening rate
Time frame: at study completion, an average of 2 years
recruitment rate
Time frame: at study completion, an average of 2 years
retention rate
Time frame: at study completion, an average of 2 years
adherence rate
Time frame: at study completion, an average of 2 years
trial burden
Time frame: from start of treatment until last visit, up to 10 days
tolerability of decolonization regimen
Time frame: day 5 of treatment
burden caused by side effects
Time frame: day 5 of treatment
willingness to participate in future main trial
Time frame: from start of treatment until last visit, up to 10 days
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)
The rate of mupirocin or oxacillin resistance
Time frame: pre-treatment (-30days to -10 days before surgery)
The rate of treatment side effects
Time frame: day 1-5 of treatment]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Polyhexanide and Mupirocin and Chlorhexidine in people with Staphylococcus Aureus and Colonization, Asymptomatic, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
randomization rate (time frame: at study completion, an average of 2 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.