Effectiveness of Routine Sterile Gloving in Blood Culture | NCT00973063

Studies
Effectiveness of Routine Sterile Gloving in Blood Culture

NCT00973063

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Dec 4, 2013Estimated

Enrollment

1,854Actual

Phase

Not Applicable

Conditions

Bacteremia

Interventions

Routine sterile gloving

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
SNUHIMI01

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Sep 7, 2009

First Submission Date that Met QC Criteria

Sep 8, 2009

First Posted Date

Sep 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2013

Last Update Posted Date

Dec 4, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wan Beom Park, Associate Professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,854Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
conventional gloving	No Intervention
routine sterile gloving	Experimental		Behavioral: Routine sterile gloving

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Routine sterile gloving	Behavioral	routinely new sterile gloving just before sampling	routine sterile gloving

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
contamination rate in blood culture		at the time of identification of organisms

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
WAN BEOM PARK, MD	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		110-744	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21282693	Derived	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.

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D018805	Sepsis