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Randomized controlled trial of a self-administered five-day antiseptic bundle versus usual disinfectant soap showers for preoperative eradication of Staphylococcus aureus colonization

Published online by Cambridge University Press:  24 July 2018

Susan E. Kline ,
James D. Neaton ,
Ruth Lynfield ,
Patricia Ferrieri ,
Shalini Kulasingam ,
Kayleigh Dittes ,
Anita Glennen ,
Selina Jawahir ,
Alexander Kaizer  and
Jeremiah Menk
...Show all authors
Susan E. Kline*
Affiliation:
University of Minnesota Medical School, Department of Medicine, Division of Infectious Diseases, Minneapolis, Minnesota
James D. Neaton
Affiliation:
Division of Biostatistics, University of Minnesota School of Public Health, Minneapolis, Minnesota
Ruth Lynfield
Affiliation:
Minnesota Department of Health, St Paul, Minnesota
Patricia Ferrieri
Affiliation:
Department of Laboratory Medicine and Pathology, University of Minnesota Medical School, Minneapolis, Minnesota
Shalini Kulasingam
Affiliation:
Division of Epidemiology, University of Minnesota School of Public Health, Minneapolis, Minnesota
Kayleigh Dittes
Affiliation:
University of Minnesota Medical School, Department of Medicine, Division of Infectious Diseases, Minneapolis, Minnesota
Anita Glennen
Affiliation:
Minnesota Department of Health, St Paul, Minnesota
Selina Jawahir
Affiliation:
Minnesota Department of Health, St Paul, Minnesota
Alexander Kaizer
Affiliation:
Biostatistical Design and Analysis Center, University of Minnesota, Minneapolis, Minnesota
Jeremiah Menk
Affiliation:
Biostatistical Design and Analysis Center, University of Minnesota, Minneapolis, Minnesota
James R. Johnson
Affiliation:
University of Minnesota Medical School, Department of Medicine, Division of Infectious Diseases, Minneapolis, Minnesota Veterans Affairs Medical Center, Minneapolis, Minnesota
*
Author for correspondence: Susan E. Kline, Department of Medicine, Infectious Diseases Division, University of Minnesota, 420 Delaware St SE, MMC# 250, Minneapolis, MN 55455. E-mail: [email protected]
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Abstract

Objective

To determine the efficacy in eradicating Staphylococcus aureus (SA) carriage of a 5-day preoperative decolonization bundle compared to 2 disinfectant soap showers, with both regimens self-administered at home.

Design

Open label, single-center, randomized clinical trial.

Setting

Ambulatory orthopedic, urologic, neurologic, colorectal, cardiovascular, and general surgery clinics at a tertiary-care referral center in the United States.

Participants

Patients at the University of Minnesota Medical Center planning to have elective surgery and not on antibiotics.

Methods

Consenting participants were screened for SA colonization using nasal, throat, axillary, and perianal swab cultures. Carriers of SA were randomized, stratified by methicillin resistance status, to a decolonization bundle group (5 days of nasal mupirocin, chlorhexidine gluconate [CHG] bathing, and CHG mouthwash) or control group (2 preoperative showers with antiseptic soap). Colonization status was reassessed preoperatively. The primary endpoint was absence of SA at all 4 screened body sites.

Results

Of 427 participants screened between August 31, 2011, and August 9, 2016, 127 participants (29.7%) were SA carriers. Of these, 121 were randomized and 110 were eligible for efficacy analysis (57 decolonization bundle group, 53 control group). Overall, 90% of evaluable participants had methicillin-susceptible SA strains. Eradication of SA at all body sites was achieved for 41 of 57 participants (71.9%) in the decolonization bundle group and for 13 of 53 participants (24.5%) in the control group, a difference of 47.4% (95% confidence interval [CI], 29.1%–65.7%; P<.0001).

Conclusion

An outpatient preoperative antiseptic decolonization bundle aimed at 4 body sites was significantly more effective in eradicating SA than the usual disinfectant showers (ie, the control).

Trial Registration

ClinicalTrials.gov identifier: NCT02182115

Type
Original Article
Information
Infection Control & Hospital Epidemiology , Volume 39 , Issue 9 , September 2018 , pp. 1049 - 1057
Copyright
© 2018 by The Society for Healthcare Epidemiology of America. All rights reserved. 

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Footnotes

PREVIOUS PRESENTATION: Previously presented in part in abstract and poster formats with preliminary data at IDWeek 2015 in San Diego, California, on October 9, 2015, Abstract 50804. Poster 1133 and at the SHEA 2017 conference in St Louis, Missouri, on March 30, 2017 Abstract 8723, Poster 209.

Cite this article: Kline SE, et al. (2018). Randomized controlled trial of a self-administered five-day antiseptic bundle versus usual disinfectant soap showers for preoperative eradication of Staphylococcus aureus colonization. Infection Control & Hospital Epidemiology 2018, 39, 1049–1057. doi: 10.1017/ice.2018.151

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