CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 110 enrolled
Drug / intervention
antiseptic bundle +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02182115
NCT02182115Phase 4Completed

Effectiveness of Screening and Decolonization of S. Aureus in Surgery Outpatients

University of Minnesota·interventional·Posted Jul 8, 2014·Updated Nov 5, 2019

In Brief

A Phase 4 clinical trial evaluating antiseptic bundle and standard of care for Wound Infection Due to Staphylococcus Aureus and MRSA Infection of Postoperative Wound. Completed, enrolled 110 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 8, 2014
Enrollment StartJul 1, 2014
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 12.0 years ago

Interventions

antiseptic bundledrug

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

standard of caredrug

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