Staphylococcus Aureus ColonizationNCT06378359
Effectiveness of Screening and Decolonization of S. Aureus to Prevent S. Aureus Surgical Site Infections in Surgery Outpatients
An observational study of Staphylococcus Aureus Colonization and Surgical Site Infections, run by University of Minnesota at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcus Aureus Colonization, Surgical Site Infections, Healthcare Associated Infections
- What is being tested?
- Screening and decolonization for SA carriers with the 3 drug bundle, No screening for SA and no screening
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The study will recruit patients from outpatient surgical clinics at the time their surgical procedures are planned. The study team will work with collaborating surgeons at UMMC to identify these patients. The study will recruit the following NIH priority populations: low income groups, minority groups, women, the elderly and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care. These patients will be part of the surgical clinics' patient population and will be approached to participate in the study at the time their surgery is planned with their surgeon.
Who may be able to join
- Eligible participanst are outpatients in orthopedic, urology, neuro, otolaryngology, plastic and general surgery and OB/GYN clinics who are scheduled to undergo surgery at participating trial sites.
- Anticipated surgery ≥ 10 days after the date of enrollment, to allow time for completion of baseline cultures and the decolonization protocol.
- Age ≥ 18 years
- Ability to complete the decolonization protocol pre-operatively as an outpatient.
- No antibiotic therapy at the time of, or seven days prior to, baseline cultures, and no subsequent antibiotic therapy prior to the surgical procedure. Standard pre-op antibiotic prophylaxis given.
- Patients are having skin incisions as part of their scheduled surgical procedure.
Who cannot join
- Inability to give informed consent
- Surgery anticipated <10 days after the baseline cultures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota Medical Center and Clinics
Minneapolis, Minnesota, 55414
Pragya Karki, MD, 612-301-6316, pkarki@umn.edu
About this study
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
- Staphylococcus Aureus Colonization, Surgical Site Infections, Healthcare Associated Infections
- Being tested
- Screening and decolonization for SA carriers with the 3 drug bundle, No screening for SA, no screening, Nasal povidone-iodine on surgery day plus 2 CHG pre-op showers without screening., Nasal alcohol gel on surgery day plus 2 CHG pre-op showers without screening
- Medical subject headings
- Surgical Wound Infection, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening and decolonization for SA carriers with the 3 drug bundleOther
nasal mupirocin, chlorhexidine gluconate (CHG) mouth rinse and CHG soap showers x 5 days and non-SA carriers receive 2 CHG pre-op showers
No screening for SAOther
All receive the 3 drug bundle, Nasal mupirocin, chlorhexidine gluconate (CHG) mouth rinse, and CHG body wash
no screeningOther
giving pre-surgical patients the three drug decolonization bundle without screening
Nasal povidone-iodine on surgery day plus 2 CHG pre-op showers without screening.Other
Nasal povidone-iodine on surgery day plus 2 CHG pre-op showers without screening.
Nasal alcohol gel on surgery day plus 2 CHG pre-op showers without screeningOther
Nasal alcohol gel on surgery day plus 2 CHG pre-op showers without screening
| Study group | Role | What they receive |
|---|---|---|
| Arm 1a | screening for SA carriage and using the three-drug decolonization bundle among patients with SA colonization Receives: Other: Screening and decolonization for SA carriers with the 3 drug bundle | |
| Arm 1b | non SA carriers in this arm will get two pre-op showers with an antiseptic soap Receives: Other: No screening for SA | |
| Arm 2 | giving pre-surgical patients the three drug decolonization bundle without screening.
Nasal mupirocin, chlorhexidine gluconate (CHG) mouth rinse, and CHG body wash Receives: Other: no screening | |
| Arm 3 | giving pre-op nasal povidone iodine without screening Receives: Other: Nasal povidone-iodine on surgery day plus 2 CHG pre-op showers without screening. | |
| Arm 4 | giving nasal alcohol gel without screening Receives: Other: Nasal alcohol gel on surgery day plus 2 CHG pre-op showers without screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy in eradicating Staphylococcus aureus (SA)
The study will compare the efficacy of four different decolonizing approaches and products in eradicating Staphylococcus aureus (SA) before surgery.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start29 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus Aureus ColonizationStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Kline, MD, MPH, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06378359
- Sponsor's protocol ID
- IDIM-2023-32364
- Status last verified
- Jan 2026
- First submitted
- 18 Apr 2024
- Last updated
- 14 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Screening and Decolonization of S. Aureus to Prevent S. Aureus Surgical Site Infections in Surgery Outpatients
- ClinicalTrials.gov ID
- NCT06378359
- Acronym / sponsor ID
- IDIM-2023-32364
- Conditions
- Staphylococcus Aureus Colonization, Surgical Site Infections, Healthcare Associated Infections
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Apr 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1a | – | Other: Screening and decolonization for SA carriers with the 3 drug bundlescreening for SA carriage and using the three-drug decolonization bundle among patients with SA colonization |
| Arm 1b | – | Other: No screening for SAnon SA carriers in this arm will get two pre-op showers with an antiseptic soap |
| Arm 2 | – | Other: no screeninggiving pre-surgical patients the three drug decolonization bundle without screening. Nasal mupirocin, chlorhexidine gluconate (CHG) mouth rinse, and CHG body wash |
| Arm 3 | – | Other: Nasal povidone-iodine on surgery day plus 2 CHG pre-op showers without screening.giving pre-op nasal povidone iodine without screening |
| Arm 4 | – | Other: Nasal alcohol gel on surgery day plus 2 CHG pre-op showers without screeninggiving nasal alcohol gel without screening |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will recruit patients from outpatient surgical clinics at the time their surgical procedures are planned. The study team will work with collaborating surgeons at UMMC to identify these patients. The study will recruit the following NIH priority populations: low income groups, minority groups, women, the elderly and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care. These patients will be part of the surgical clinics' patient population and will be approached to participate in the study at the time their surgery is planned with their surgeon.
Key inclusion criteria (6 listed)
- Eligible participanst are outpatients in orthopedic, urology, neuro, otolaryngology, plastic and general surgery and OB/GYN clinics who are scheduled to undergo surgery at participating trial sites.
- Anticipated surgery ≥ 10 days after the date of enrollment, to allow time for completion of baseline cultures and the decolonization protocol.
- Age ≥ 18 years
- Ability to complete the decolonization protocol pre-operatively as an outpatient.
- No antibiotic therapy at the time of, or seven days prior to, baseline cultures, and no subsequent antibiotic therapy prior to the surgical procedure. Standard pre-op antibiotic prophylaxis given.
Key exclusion criteria (2 listed)
- Inability to give informed consent
- Surgery anticipated <10 days after the baseline cultures
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 |
|---|---|---|
| Screening and decolonization for SA carriers with the 3 drug bundlenasal mupirocin, chlorhexidine gluconate (CHG) mouth rinse and CHG soap showers x 5 days and non-SA carriers receive 2 CHG pre-op showers | Other | Arm 1a |
| No screening for SAAll receive the 3 drug bundle, Nasal mupirocin, chlorhexidine gluconate (CHG) mouth rinse, and CHG body wash | Other | Arm 1b |
| no screeninggiving pre-surgical patients the three drug decolonization bundle without screening | Other | Arm 2 |
| Nasal povidone-iodine on surgery day plus 2 CHG pre-op showers without screening.Nasal povidone-iodine on surgery day plus 2 CHG pre-op showers without screening. | Other | Arm 3 |
| Nasal alcohol gel on surgery day plus 2 CHG pre-op showers without screeningNasal alcohol gel on surgery day plus 2 CHG pre-op showers without screening | Other | Arm 4 |
Primary outcome
Efficacy in eradicating Staphylococcus aureus (SA)
Time frame: baseline
The study will compare the efficacy of four different decolonizing approaches and products in eradicating Staphylococcus aureus (SA) before surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
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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.
Susan Kline, MD, MPH principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Staphylococcus Aureus Colonization and Surgical Site Infections, run by University of Minnesota at 1 site in United States.
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 6 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 14 Jan 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 United States. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Rottman (612-626-3662, rothm029@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy in eradicating Staphylococcus aureus (SA) (time frame: baseline). 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 14 Jan 2026.