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Evaluating Central Line Hub Contamination Using a Novel Capping Device

Primary Purpose

Catheter-related Bloodstream Infection Due to Central Venous Catheter

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Disinfecting Cap
Sponsored by
NorthShore University HealthSystem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Catheter-related Bloodstream Infection Due to Central Venous Catheter

Eligibility Criteria

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

Inclusion Criteria:

  • Adult patients with peripherally inserted central catheters (PICC) inserted during their index hospitalization plus 5 or more consecutive PICC line days were consented and enrolled.

Exclusion Criteria:

  • Minors and adult inpatients without PICCs or with PICCs for < 5 days

Sites / Locations

  • NorthShore: Evanston HospitalRecruiting
  • NorthShore: Glenbrook HospitalRecruiting
  • NorthShore: Highland Park HospitalRecruiting
  • NorthShore: Skokie HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Glenbrook Hospital

Evanston, Highland Park, Skokie Hospitals

Arm Description

Immediate implementation of the disinfecting cap, no baseline contamination assessment, historical infection data only.

Phase 1: Assess baseline contamination rate for patients with PICC catheters for 3-12 months. Phase 2: Implement intervention. Assess contamination 3-12 months. Phase 3: (optional): Remove cap asses contamination rate (3-6 months)

Outcomes

Primary Outcome Measures

Quantitative contamination of intraluminal fluid from central venous catheters (discard) as measured in CFU/ml
For the research project, we will monitor the colonization of access port colonization in routine as well as SwabCap™ cared for lines as follows: Specimen sampling will be done by obtaining one specimen of 1.0 mL of aspirate will be withdrawn from each unused catheter lumen during first morning rounds in a separate syringe; then placed in a epdiatric Isolator tube.

Secondary Outcome Measures

Central line associated bloodstream infections
Central line-associated bloodstream infections (CLABSI) as defined by the National Healthcare Safety Network (NHSN) of all patients throughout 4 hospitals in 2009-2011.

Full Information

First Posted
February 22, 2011
Last Updated
February 22, 2011
Sponsor
NorthShore University HealthSystem
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1. Study Identification

Unique Protocol Identification Number
NCT01301300
Brief Title
Evaluating Central Line Hub Contamination Using a Novel Capping Device
Official Title
Demonstration of Central Line Hub Contamination Reduction Using a Novel Capping Device
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
NorthShore University HealthSystem

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Excelsior Medical has developed SwabCap™, a luer access valve disinfection cap. The SwabCap™ provides passive disinfection of valve top and threads without activating the luer access valve. This product promotes technique standardization and compliance in cleansing of the luer access valve prior to access. It acts as a physical barrier from touch and airborne contamination for up to 96 hours. This product has been endorsed and will be adopted for use at NorthShore University HealthSystem as a quality improvement initiative. This research study protocol is designed to confirm the anticipated benefit of this change in practice at NorthShore during the planned implementation and use. If the product performs as it has been designed to, the baseline rate of hub and subsequently intraluminal contamination will be diminished, thereby protecting patients with central lines from bloodstream infections due to contaminated hubs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheter-related Bloodstream Infection Due to Central Venous Catheter

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Glenbrook Hospital
Arm Type
Active Comparator
Arm Description
Immediate implementation of the disinfecting cap, no baseline contamination assessment, historical infection data only.
Arm Title
Evanston, Highland Park, Skokie Hospitals
Arm Type
Active Comparator
Arm Description
Phase 1: Assess baseline contamination rate for patients with PICC catheters for 3-12 months. Phase 2: Implement intervention. Assess contamination 3-12 months. Phase 3: (optional): Remove cap asses contamination rate (3-6 months)
Intervention Type
Device
Intervention Name(s)
Disinfecting Cap
Other Intervention Name(s)
SwabCap SC003 2000
Intervention Description
Replace standard practice with using the disinfecting cap
Primary Outcome Measure Information:
Title
Quantitative contamination of intraluminal fluid from central venous catheters (discard) as measured in CFU/ml
Description
For the research project, we will monitor the colonization of access port colonization in routine as well as SwabCap™ cared for lines as follows: Specimen sampling will be done by obtaining one specimen of 1.0 mL of aspirate will be withdrawn from each unused catheter lumen during first morning rounds in a separate syringe; then placed in a epdiatric Isolator tube.
Time Frame
Throughout the study with enrolled subjects (The catheter must have been in place for a period of 5 or more days before the first sample is taken.)
Secondary Outcome Measure Information:
Title
Central line associated bloodstream infections
Description
Central line-associated bloodstream infections (CLABSI) as defined by the National Healthcare Safety Network (NHSN) of all patients throughout 4 hospitals in 2009-2011.
Time Frame
Throughout the study and from historical data

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients with peripherally inserted central catheters (PICC) inserted during their index hospitalization plus 5 or more consecutive PICC line days were consented and enrolled. Exclusion Criteria: Minors and adult inpatients without PICCs or with PICCs for < 5 days
Facility Information:
Facility Name
NorthShore: Evanston Hospital
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sue Boehm, RN
Phone
847-926-5860
Email
sboehm@northshore.org
First Name & Middle Initial & Last Name & Degree
Marc Wright, MS
Phone
8475702420
Email
mwright@northshore.org
Facility Name
NorthShore: Glenbrook Hospital
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sue Boehm, RN
Phone
847-926-5860
Email
sboehm@northshore.org
First Name & Middle Initial & Last Name & Degree
Marc Wright, MS
Phone
8475702420
Email
mwright@northshore.org
Facility Name
NorthShore: Highland Park Hospital
City
Highland Park
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sue Boehm, RN
Phone
847-926-5860
Email
sboehm@northshore.org
First Name & Middle Initial & Last Name & Degree
Marc Wright, MS
Phone
8475702420
Email
mwright@northshore.org
Facility Name
NorthShore: Skokie Hospital
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sue ' Boehm, RN
Phone
847-926-5860
Email
sboehm@northshore.org
First Name & Middle Initial & Last Name & Degree
Marc Wright, MS
Phone
8475702420

12. IPD Sharing Statement

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Evaluating Central Line Hub Contamination Using a Novel Capping Device

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