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
Shaare Zedek Medical Center
Magnolia Medical Technologies, Inc.
Information provided by (Responsible Party):
Shaare Zedek Medical Center
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1500 participants|
|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|
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
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).
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).
Wipes containing alcohol (70%) and chlorhexidine (2%) to achieve skin sterilization
Primary Outcome Measures :
- 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 :
- Ease of use of SteriPath device as evaluated by resident physicians and phlebotomists using a questionaire [ Time Frame: 6 months ]
- 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 ]
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