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Antiseptic

antiseptic bundle for Staph Infection

Phase 4
Waitlist Available
Led By Susan E 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 immediately prior to surgery patients are swabbed again at the 4 body sites to see if sa is present or not.
Awards & highlights

Summary

Staphylococcus aureus (SA) healthcare-associated infections (HAI) cause significant morbidity and mortality. SA causes 15% of all HAI and 30% of surgical site infections (SSIs). Each year over 40 million Americans undergo operations, 1-10% of whom will acquire SSIs. Such infections double the length of hospitalization and risk of dying, and increase U.S. health care costs by $5-10 billion/year. We need effective interventions to prevent SSIs caused by either methicillin-susceptible (MSSA) or methicillin-resistant (MRSA) strains. Nasal carriers of SA (25-30% of adults) have a 2-14 times greater risk than non-carriers of acquiring an SA SSI. A potential prevention approach is routine pre-operative screening of patients, followed by decolonization of identified SA carriers.

Eligible Conditions
  • Staph Infection
  • Staphylococcus aureus Infection of Postoperative Wound

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately prior to surgery patients are swabbed again at the 4 body sites to see if sa is present or not.
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately prior to surgery patients are swabbed again at the 4 body sites to see if sa is present or not. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Eradication of Staphylococcus Aureus (SA) Carriage at All 4 Body Sites Tested.

Side effects data

From 2016 Phase 4 trial • 110 Patients • NCT02182115
2%
non-healing wound
2%
radial nerve palsy
2%
bacteremia
2%
Pneumonia
2%
pulmonary embolus
2%
DVT
2%
UTI
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard of Care
Antiseptic Bundle

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: antiseptic bundleExperimental Treatment1 Intervention
Patients to use study bundle for 5 days prior to scheduled surgery with the following medications to use at home. 1. Chlorhexidine gluconate soap applied for bathing daily. 2. Chlorhexidine gluconate mouthrinse used to rinse mouth twice daily. 3. Nasal mupirocin to applied inside nostrils twice daily.
Group II: standard of careActive Control1 Intervention
Surgeon's routine for preoperative showering.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
antiseptic bundle
2014
Completed Phase 4
~110

Find a Location

Who is running the clinical trial?

Agency for Healthcare Research and Quality (AHRQ)FED
405 Previous Clinical Trials
6,756,555 Total Patients Enrolled
University of MinnesotaLead Sponsor
1,413 Previous Clinical Trials
1,561,293 Total Patients Enrolled
Susan E Kline, MD, MPHPrincipal InvestigatorUniversity of Minnesota
~10 spots leftby Sep 2025
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