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NCT06378359 · ClinicalTrials.gov registry record
Effectiveness of Screening and Decolonization of S. Aureus to Prevent S. Aureus Surgical Site Infections in Surgery Outpatients
A clinical trial of Surgical Site Infections and Healthcare Associated Infections, sponsored by University of Minnesota.
- Recruiting
- Registry status
- 250
- Enrollment target
- 1
- Study location
NCT06378359 is a study of Surgical Site Infections and Healthcare Associated Infections that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 250 participants, below the 1,804-participant average among 3 other Surgical Site Infections trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06378359, a study of Surgical Site Infections and Healthcare Associated Infections, is actively recruiting participants, sponsored by University of Minnesota.
- RECRUITING
- Registry status
- 250 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of the study is to determine the effectiveness, safety, and health-care utilization and costs of a preoperative Staphylococcus aureus (SA) screening and decolonization bundle, (5 days of nasal mupirocin ointment, chlorhexidine gluconate (CHG) body wash, and CHG mouth rinse), in eradicating SA carriage compared to other SA decolonization approaches. The study will conduct a single center pilot trial to compare efficacy of different SA decolonization approaches in pre-surgical patients, in eradicating SA carriage, after obtaining informed consent. The study will compare four different approaches, Arm 1) screen for SA carriage and using the three-drug decolonization bundle for 5 days among patients with SA colonization, non SA carriers in this arm will get two pre-op showers with CHG soap, Arm 2) all participants receive the three drug decolonization bundle, Arm 3) all receive pre-op nasal povidone iodine the day of surgery plus two pre-op showers with CHG soap, and Arm 4) all receive nasal alcohol gel the day of surgery plus two pre op showers with CHG soap. The primary efficacy outcome will be eradication of SA colonization at all 5 body sites. Secondary outcomes will be SA surgical site infections (SSIs), all SSIs, and SA healthcare associated infections (HAIs). The study will also compare eradication of SA from each of the 5 body sites as a secondary outcome.
Conditions Studied
Interventions
- OTHER Screening and decolonization for SA carriers with the 3 drug bundle
- OTHER No screening for SA
- OTHER no screening
- OTHER Nasal povidone-iodine on surgery day plus 2 CHG pre-op showers without screening.
- OTHER Nasal alcohol gel on surgery day plus 2 CHG pre-op showers without screening
Study Locations (1)
Minnesota
- University of Minnesota Medical Center and Clinics - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2024-01-29 |
| Est. Completion | 2026-12-31 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06378359
The ClinicalTrials.gov registry entry for NCT06378359 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,804-participant average among 3 other Surgical Site Infections trials with a reported enrollment target (86% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Surgical Site Infections appearing as the primary indexed condition, and to 5 interventions - of which Screening and decolonization for SA carriers with the 3 drug bundle is the first listed.
NCT06378359 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT06378359 about?
NCT06378359 is a clinical study titled "Effectiveness of Screening and Decolonization of S. Aureus to Prevent S. Aureus Surgical Site Infections in Surgery Outpatients". The purpose of the study is to determine the effectiveness, safety, and health-care utilization and costs of a preoperative Staphylococcus aureus (SA) screening and decolonization bundle, (5 days of nasal mupirocin ointment, chlorhexidine gluconate (CHG) body wash, and CHG mouth rinse), in eradicati...
What is the current status of trial NCT06378359?
This trial is currently recruiting. The enrollment target is 250 participants. The study started on 2024-01-29. Estimated completion is 2026-12-31.
What conditions does trial NCT06378359 study?
This clinical trial studies the following conditions: Surgical Site Infections, Healthcare Associated Infections, Staphylococcus Aureus Colonization.
What interventions are being tested in trial NCT06378359?
The interventions under investigation include: Screening and decolonization for SA carriers with the 3 drug bundle (OTHER), No screening for SA (OTHER), no screening (OTHER), Nasal povidone-iodine on surgery day plus 2 CHG pre-op showers without screening. (OTHER), Nasal alcohol gel on surgery day plus 2 CHG pre-op showers without screening (OTHER).
Who is sponsoring clinical trial NCT06378359?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06378359 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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