NCT00973063

Brief Summary

The purpose of this study is to determine whether routine sterile gloving can lower contamination rates in blood culture.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,854

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

December 4, 2013

Status Verified

December 1, 2013

Enrollment Period

9 months

First QC Date

September 7, 2009

Last Update Submit

December 3, 2013

Conditions

Bacteremia

Keywords

bacteremiablood culturecontamination

Outcome Measures

Primary Outcomes (1)

  • contamination rate in blood culture

    at the time of identification of organisms

Study Arms (2)

conventional gloving

NO INTERVENTION

routine sterile gloving

EXPERIMENTAL
Behavioral: Routine sterile gloving

Interventions

Routine sterile glovingBEHAVIORAL

routinely new sterile gloving just before sampling

routine sterile gloving

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients in whom Blood culture is medically needed

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 21282693DERIVED

MeSH Terms

Conditions

Bacteremia

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • WAN BEOM PARK, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 7, 2009

First Posted

September 9, 2009

Study Start

March 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

December 4, 2013

Record last verified: 2013-12

Locations

KR(1)