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Effectiveness of Routine Sterile Gloving in Blood Culture

Primary Purpose

Bacteremia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Routine sterile gloving
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bacteremia focused on measuring bacteremia, blood culture, contamination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The patients in whom Blood culture is medically needed

Exclusion Criteria:

  • Blood sample is obtained through central venous catheter or arterial line
  • No consent to this study

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

conventional gloving

routine sterile gloving

Arm Description

Outcomes

Primary Outcome Measures

contamination rate in blood culture

Secondary Outcome Measures

Full Information

First Posted
September 7, 2009
Last Updated
December 3, 2013
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00973063
Brief Title
Effectiveness of Routine Sterile Gloving in Blood Culture
Official Title
Influence of Routine Sterile Gloving on Contamination Rates in Blood Culture
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacteremia
Keywords
bacteremia, blood culture, contamination

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1854 (Actual)

8. Arms, Groups, and Interventions

Arm Title
conventional gloving
Arm Type
No Intervention
Arm Title
routine sterile gloving
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Routine sterile gloving
Intervention Description
routinely new sterile gloving just before sampling
Primary Outcome Measure Information:
Title
contamination rate in blood culture
Time Frame
at the time of identification of organisms

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patients in whom Blood culture is medically needed Exclusion Criteria: Blood sample is obtained through central venous catheter or arterial line No consent to this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
WAN BEOM PARK, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
21282693
Citation
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.
Results Reference
derived

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Effectiveness of Routine Sterile Gloving in Blood Culture

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