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Arm 1a for Surgical Site Infection

N/A
Recruiting
Led By Susan Kline, MD, MPH
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

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.

Eligible Conditions
  • Staph Infection
  • Surgical Site Infection
  • Healthcare-Associated Infections

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy in eradicating Staphylococcus aureus (SA)

Trial Design

5Treatment groups
Experimental Treatment
Group I: Arm 4Experimental Treatment1 Intervention
giving nasal alcohol gel without screening
Group II: Arm 3Experimental Treatment1 Intervention
giving pre-op nasal povidone iodine without screening
Group III: Arm 2Experimental Treatment1 Intervention
giving pre-surgical patients the three drug decolonization bundle without screening. Nasal mupirocin, chlorhexidine gluconate (CHG) mouth rinse, and CHG body wash
Group IV: Arm 1bExperimental Treatment1 Intervention
non SA carriers in this arm will get two pre-op showers with an antiseptic soap
Group V: Arm 1aExperimental Treatment1 Intervention
screening for SA carriage and using the three-drug decolonization bundle among patients with SA colonization

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,381 Previous Clinical Trials
1,551,034 Total Patients Enrolled
Susan Kline, MD, MPHPrincipal InvestigatorUniversity of Minnesota

Frequently Asked Questions

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~167 spots leftby Dec 2025