BacteremiaNCT00973063
Effectiveness of Routine Sterile Gloving in Blood Culture
A study testing Routine sterile gloving in people with Bacteremia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether routine sterile gloving can lower contamination rates in blood culture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacteremia
- What is being tested?
- Routine sterile gloving
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,854 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2009to Dec 2009
- 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
- The patients in whom Blood culture is medically needed
Who cannot join
- Blood sample is obtained through central venous catheter or arterial line
- No consent to this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Routine Sterile Gloving on Contamination Rates in Blood Culture
The purpose of this study is to determine whether routine sterile gloving can lower contamination rates in blood culture.
Read the detailed description
Because contamination during sampling for blood culture may interfere in interpreting the results of blood culture, lowering the contamination rates in blood culture is very important. According to current guideline, routine sterile gloving is not recommended. We hypothesized that routine sterile gloving can lower contamination rates in blood culture.
- Conditions
- Bacteremia
- Being tested
- Routine sterile gloving
- Keywords
- bacteremia, blood culture, contamination
- Medical subject headings
- Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine sterile glovingBehavioural
routinely new sterile gloving just before sampling
| Study group | Role | What they receive |
|---|---|---|
| conventional gloving | No intervention | Not described |
| routine sterile gloving | Experimental | Not described Receives: Behavioral: Routine sterile gloving |
What is being measured
The primary outcome is the main question the study is designed to answer.
contamination rate in blood culture
Measured: at the time of identification of organisms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BacteremiaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,854 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wan Beom Park, Seoul National University Hospital
- Investigators
- WAN BEOM PARK, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973063
- Sponsor's protocol ID
- 0906-029-283
- Other IDs
- SNUHIMI01
- Status last verified
- Dec 2013
- First submitted
- 7 Sep 2009
- Last updated
- 4 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim NH, Kim M, Lee S, Yun NR, Kim KH, Park SW, Kim HB, Kim NJ, Kim EC, Park WB, Oh MD. Effect of routine sterile gloving on contamination rates in blood culture: a cluster randomized trial. Ann Intern Med. 2011 Feb 1;154(3):145-51. doi: 10.7326/0003-4819-154-3-201102010-00003.
PubMed 21282693
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Routine Sterile Gloving on Contamination Rates in Blood Culture
- ClinicalTrials.gov ID
- NCT00973063
- Acronym / sponsor ID
- 0906-029-283
- Conditions
- Bacteremia
- Keywords
- bacteremia, blood culture, contamination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,854 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 9 Sep 2009 (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.
The purpose of this study is to determine whether routine sterile gloving can lower contamination rates in blood culture.
Detailed description
Because contamination during sampling for blood culture may interfere in interpreting the results of blood culture, lowering the contamination rates in blood culture is very important. According to current guideline, routine sterile gloving is not recommended. We hypothesized that routine sterile gloving can lower contamination rates in blood culture.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional gloving | No intervention | – |
| routine sterile gloving | Experimental | Behavioral: Routine sterile gloving |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients in whom Blood culture is medically needed
Key exclusion criteria (2 listed)
- Blood sample is obtained through central venous catheter or arterial line
- No consent to this study
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 |
|---|---|---|
| Routine sterile glovingroutinely new sterile gloving just before sampling | Behavioural | routine sterile gloving |
Primary outcome
contamination rate in blood culture
Time frame: at the time of identification of organisms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
- Derived from this study: PubMed 21282693Kim NH, Kim M, Lee S, Yun NR, Kim KH, Park SW, Kim HB, Kim NJ, Kim EC, Park WB, Oh MD. Effect of routine sterile gloving on contamination rates in blood culture: a cluster randomized trial. Ann Intern Med. 2011 Feb 1;154(3):145-51. doi: 10.7326/0003-4819-154-3-201102010-00003.
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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.
WAN BEOM PARK, MD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine sterile gloving in people with Bacteremia, run by Seoul National University Hospital at 1 site in South Korea.
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 2 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: finished, as of the sponsor's last update on 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
contamination rate in blood culture (time frame: at the time of identification of organisms). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00973063, which also lists 1 linked publication.
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 4 Dec 2013.