Reducing Blood Culture Contamination:

NCT ID: NCT02754791

Last Updated: 2016-05-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2017-05-31

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.

Conditions

Preventing Blood Culture Contamination

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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).

Group Type: EXPERIMENTAL

Steripath

Intervention Type: DEVICE

A device that diverts the first 2 ml of blood drawn in order to reduce contamination

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).

Group Type: EXPERIMENTAL

Soluprep

Intervention Type: DEVICE

Wipes containing alcohol (70%) and chlorhexidine (2%) to achieve skin sterilization

Interventions

Steripath

A device that diverts the first 2 ml of blood drawn in order to reduce contamination

Intervention Type: DEVICE

Soluprep

Wipes containing alcohol (70%) and chlorhexidine (2%) to achieve skin sterilization

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• none

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Magnolia Medical Technologies, Inc.

INDUSTRY

Sponsor Role: collaborator

3M

INDUSTRY

Sponsor Role: collaborator

Shaare Zedek Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

42/16

Identifier Type: -

Identifier Source: org_study_id