NCT06633588

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
12mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress51%
May 2025Apr 2027

First Submitted

Initial submission to the registry

September 19, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 9, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

1.9 years

First QC Date

September 19, 2024

Last Update Submit

May 21, 2025

Conditions

Staphylococcus AureusColonization, Asymptomatic

Keywords

Staphylococcus aureus colonizationSpinal surgerydecolonization

Outcome Measures

Primary Outcomes (1)

  • randomization rate

    proportion of enrolled patients who were randomized

    at study completion, an average of 2 years.

Secondary Outcomes (11)

  • positive screening rate

    at study completion, an average of 2 years

  • recruitment rate

    at study completion, an average of 2 years

  • retention rate

    at study completion, an average of 2 years

  • adherence rate

    at study completion, an average of 2 years

  • trial burden

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

  • +6 more secondary outcomes

Study Arms (2)

Polyhexanide

EXPERIMENTAL
Drug: Polyhexanide

Mupirocin and Chlorhexidine

ACTIVE COMPARATOR
Drug: Mupirocin and Chlorhexidine

Interventions

PolyhexanideDRUG

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

Also known as: Prontoderm® Nasal Gel, Prontoderm® Foam
Polyhexanide
Mupirocin and ChlorhexidineDRUG

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

Also known as: Bactroban® Nasal Ointment, Lifo-Scrub®
Mupirocin and Chlorhexidine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

RECRUITING

MeSH Terms

Conditions

Staphylococcal InfectionsAsymptomatic Infections

Interventions

polihexanideMupirocinChlorhexidine

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsAsymptomatic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epoxy CompoundsEthers, CyclicEthersOrganic ChemicalsPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFatty AcidsLipidsBiguanidesGuanidinesAmidines

Central Study Contacts

Rami Sommerstein, Prof. Dr.

CONTACT

+41 412083254rami.sommerstein@unilu.ch

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2024

First Posted

October 9, 2024

Study Start

May 1, 2025

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

May 28, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)