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S. Aureus Screening and Decolonization

NCT02182115 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2019-11-05

Study results available
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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.

Conditions

  • Wound Infection Due to Staphylococcus Aureus
  • MRSA Infection of Postoperative Wound

Interventions

DRUG

antiseptic bundle

1. Chlorhexidine gluconate liquid soap for bathing daily. 2. Chlorhexidine gluconate mouthrinse to use twice daily. 3. Nasal mupirocin to apply twice daily.

DRUG

standard of care

Surgeon's instructions may include advising patients to use an antiseptic soap prior to surgery.

Sponsors & Collaborators

Principal Investigators

  • Susan E Kline, MD, MPH · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02182115 on ClinicalTrials.gov