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Reducing Catheter-Related Bloodstream Infections in the ICU With a Chlorhexidine-Impregnated Sponge (BIOPATCH)

NCT ID: NCT00548132

Last Updated: 2013-09-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1088 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2009-05-31

Brief Summary

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We proposed to perform a prospective randomized controlled trial to study the effect of the use of a commercially-available chlorhexidine-impregnated sponge (Biopatch) as part of central venous catheter care on catheter-related bloodstream infections among patients in two Barnes-Jewish Hospital ICUs.

Detailed Description

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At the time of the inception of this study, there were no published randomized controlled trial on the efficacy of the Biopatch in reducing bloodstream infections. Preliminary data has shown that the Biopatch decreases colonization of the catheter exit site and thereby decrease bloodstream infections but this was at that time only theoretical.

Conditions

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Catheter-related Bloodstream Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Patients in this arm will continue to get routine care

Group Type NO_INTERVENTION

No interventions assigned to this group

Chlorhexidine-impregnated foam dressing

Patient's catheters were cleaned with chlorhexidine-alcohol solution at least weekly before application of the Biopatch. These were evaluated daily and if the dressing was bloody, soiled or damaged, the dressing and the Biopatch were replaced prior to the 7-day period.

Group Type EXPERIMENTAL

Chlorhexidine-impregnated foam dressing

Intervention Type DEVICE

Patients in the treatment arm will have the Biopatch incorporated into their catheter care protocol. ICU nurses were instructed on the proper use of this novel dressing/sponge. Catheter dressing changes will only be done every 7 days unless there is visible blood, soiling underneath the dressing, or if the dressing comes off.

Interventions

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Chlorhexidine-impregnated foam dressing

Patients in the treatment arm will have the Biopatch incorporated into their catheter care protocol. ICU nurses were instructed on the proper use of this novel dressing/sponge. Catheter dressing changes will only be done every 7 days unless there is visible blood, soiling underneath the dressing, or if the dressing comes off.

Intervention Type DEVICE

Other Intervention Names

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Biopatch Antimicrobial Dressing

Eligibility Criteria

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Inclusion Criteria

* patients who are admitted to the ICU with a central venous catheter (i.e. triple lumen catheters, quadruple lumen catheters, percutaneously inserted central catheters, arterial catheters, intraaortic balloon pumps, Swan-Ganz catheters).

Exclusion Criteria

* patients who are not enrolled into the trial within 7 days of having the catheter being placed and patients who are allergic to chlorhexidine.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bernard C Camins, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Barnes- Jewish Hospital

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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WUSM HRPO# 05-1186

Identifier Type: -

Identifier Source: secondary_id

00424-0805-01 (BJH Foundation)

Identifier Type: -

Identifier Source: org_study_id