Reducing Blood Culture Contamination:

Not Applicable

• Conditions: Preventing Blood Culture Contamination
• Interventions: Device: Steripath; Device: Soluprep

• Registration Number: NCT02754791
• Lead Sponsor: Shaare Zedek Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-19
• Study First Submitted QC: 2016-04-25
• Study First Posted: 2016-04-28
• Status Verified: 2016-05
• Study Start: 2016-05
• Last Update Submitted: 2016-05-02
• Last Update Posted: 2016-05-03
• Primary Completion: 2017-05
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

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

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Steripath	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).
Soluprep wipes	Soluprep	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).

Primary Outcome Measures

Name	Time	Method
Percentage of contaminated blood cultures relative to overall blood cultures as compared to percentage in historical and parallel control groups	6 months

Secondary Outcome Measures

Name	Time	Method
Ease of use of SteriPath device as evaluated by resident physicians and phlebotomists using a questionaire	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	6 months