Decolonization Efficacy of Polyhexanide vs. Mupirocin

NCT ID: NCT06633588

Last Updated: 2025-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2027-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Staphylococcus Aureus Colonization, Asymptomatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Polyhexanide

Group Type EXPERIMENTAL

Polyhexanide

Intervention Type DRUG

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

Mupirocin and Chlorhexidine

Group Type ACTIVE_COMPARATOR

Mupirocin and Chlorhexidine

Intervention Type DRUG

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

Interventions

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Polyhexanide

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

Intervention Type DRUG

Mupirocin and Chlorhexidine

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

Intervention Type DRUG

Other Intervention Names

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Prontoderm® Nasal Gel, Prontoderm® Foam Bactroban® Nasal Ointment, Lifo-Scrub®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swiss Paraplegic Research, Nottwil

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Rami Sommerstein, Prof. Dr.

Role: CONTACT

+41 412083254

Facility Contacts

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Rami Sommerstein, Prof. Dr.

Role: primary

+41 412083254

Other Identifiers

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2024-08

Identifier Type: -

Identifier Source: org_study_id

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