Preventing Blood Culture ContaminationNCT02754791
Reducing Blood Culture Contamination:
A study testing Steripath and Soluprep in people with Preventing Blood Culture Contamination, run by Shaare Zedek Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preventing Blood Culture Contamination
- What is being tested?
- Steripath and Soluprep
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- May 2016to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients hospitalized in our institution in whom blood cultures are taken
Who cannot join
- none
About this study
Official title: Reducing Blood Culture Contamination: a Prospective Crossover Study
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
- Being tested
- Steripath, Soluprep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SteripathDevice
A device that diverts the first 2 ml of blood drawn in order to reduce contamination
SoluprepDevice
Wipes containing alcohol (70%) and chlorhexidine (2%) to achieve skin sterilization
| Study group | Role | What they receive |
|---|---|---|
| Monthly report | No intervention | 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 |
| Steripath | Experimental | 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). Receives: Device: Steripath |
| Soluprep wipes | Experimental | 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). Receives: Device: Soluprep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of contaminated blood cultures relative to overall blood cultures as compared to percentage in historical and parallel control groups
Measured: 6 months
Secondary outcomes (2)
Ease of use of SteriPath device as evaluated by resident physicians and phlebotomists using a questionaire
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preventing Blood Culture ContaminationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Magnolia Medical Technologies, Inc., 3M
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754791
- Sponsor's protocol ID
- 42/16
- Status last verified
- May 2016
- First submitted
- 19 Apr 2016
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Blood Culture Contamination: a Prospective Crossover Study
- ClinicalTrials.gov ID
- NCT02754791
- Acronym / sponsor ID
- 42/16
- Conditions
- Preventing Blood Culture Contamination
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Collaborators
- Magnolia Medical Technologies, Inc., 3M
- Study start
- May 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Monthly report | No intervention | –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 |
| Steripath | Experimental | Device: SteripathThe 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 | Experimental | Device: SoluprepIn 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients hospitalized in our institution in whom blood cultures are taken
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SteripathA device that diverts the first 2 ml of blood drawn in order to reduce contamination | Device | Steripath |
| SoluprepWipes containing alcohol (70%) and chlorhexidine (2%) to achieve skin sterilization | Device | Soluprep wipes |
Primary outcome
Percentage of contaminated blood cultures relative to overall blood cultures as compared to percentage in historical and parallel control groups
Time frame: 6 months
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2016.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Steripath and Soluprep in people with Preventing Blood Culture Contamination, run by Shaare Zedek Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of contaminated blood cultures relative to overall blood cultures as compared to percentage in historical and parallel control groups (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2016; AzTrials last refreshed its copy on 29 Oct 2026.