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Reducing Blood Culture Contamination:

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ClinicalTrials.gov Identifier: NCT02754791
Recruitment Status : Unknown
Verified May 2016 by Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : April 28, 2016
Last Update Posted : May 3, 2016
Sponsor:
Collaborators:
Magnolia Medical Technologies, Inc.
3M
Information provided by (Responsible Party):
Shaare Zedek Medical Center

Study Description
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Brief Summary:
Bloodstream infections cause significant morbidity and mortality and their prompt identification is an essential part of modern medicine. False positive results in blood cultures are primarily due to contaminants. It has been estimated that up to 50% of positive blood cultures represent contamination. These false positive cultures, at the microbiological laboratory level, require significant additional resources for workup. Additionally, they result in unnecessary antibiotic treatment and hospitalization days, causing needless harm to patients. Various methods have been implemented in order to reduce blood culture contaminants, including modifying the solution used for sterilizing the skin and feedback on contamination rates. However, it has been shown that the bacteria which colonize the human skin are not only on the surface but in fact colonize deeper surfaces as well. The SteriPath device diverts the initial 1-2 ml blood so as to remove any potential skin plug with contaminants. Thus, the principle object of this study is the determination of the rate of contamination of blood culture taken prior to initiating intervention versus the rate of contamination using three interventions: Monthly feedback via departmental report card, a chlorhexidine plus alcohol wipe and the SteriPath device. Secondary objectives will include ease of use of the wipes and the SteriPath device and an estimate of the sensitivity of SteriPath device use to true bacteremia. If the various interventions will be shown to reduce contamination, researchers will also attempt to estimate the financial effects of those reductions, comparing intervention cost to estimated savings related to reduced contamination.

Condition or disease Intervention/treatment Phase
Preventing Blood Culture Contamination Device: Steripath Device: Soluprep Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Reducing Blood Culture Contamination: a Prospective Crossover Study
Study Start Date : May 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2017
Arms and Interventions
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Arm Intervention/treatment
No Intervention: Monthly report
A monthly report will be submitted to department heads describing their departments rate of blood culture contamination and comparing it to blood culture contamination rate in previous months and to blood culture contamination rate of the hospital as a whole
Experimental: Steripath
The Steripath device (Magnolia) will be used to take blood cultures in this arm instead of standard methods. This will be in addition to a departmental monthly report (described above).
 Device: Steripath
A device that diverts the first 2 ml of blood drawn in order to reduce contamination
Experimental: Soluprep wipes
In this arm, skin sterilization will be achieved using Soluprep wipes (3M) instead of standard methods (alcohol wipes).This will be in addition to a departmental monthly report (described above).
 Device: Soluprep
Wipes containing alcohol (70%) and chlorhexidine (2%) to achieve skin sterilization


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of contaminated blood cultures relative to overall blood cultures as compared to percentage in historical and parallel control groups [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Ease of use of SteriPath device as evaluated by resident physicians and phlebotomists using a questionaire [ Time Frame: 6 months ]
  2. Cost effectiveness of Steripath device and chlorhexidine wipes in measured as cost of devices in dollars versus reduction of cost in dollars associated with reduced blood culture contamination [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients hospitalized in our institution in whom blood cultures are taken

Exclusion Criteria:

  • none
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT02754791    
Other Study ID Numbers: 42/16
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: May 3, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided