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Evaluating Central Line Hub Contamination Using a Novel Capping Device

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by NorthShore University HealthSystem Research Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
NorthShore University HealthSystem Research Institute
ClinicalTrials.gov Identifier:
NCT01301300
First received: February 22, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Catheter-related Bloodstream Infection Due to Central Venous Catheter
Device: Disinfecting Cap
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Demonstration of Central Line Hub Contamination Reduction Using a Novel Capping Device

Further study details as provided by NorthShore University HealthSystem Research Institute:

Primary Outcome Measures:
  • Quantitative contamination of intraluminal fluid from central venous catheters (discard) as measured in CFU/ml [ 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.) ] [ Designated as safety issue: No ]

    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 [ Time Frame: Throughout the study and from historical data ] [ Designated as safety issue: No ]
    Central line-associated bloodstream infections (CLABSI) as defined by the National Healthcare Safety Network (NHSN) of all patients throughout 4 hospitals in 2009-2011.


Estimated Enrollment: 600
Study Start Date: April 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Glenbrook Hospital
Immediate implementation of the disinfecting cap, no baseline contamination assessment, historical infection data only.
Device: Disinfecting Cap
Replace standard practice with using the disinfecting cap
Other Name: SwabCap SC003 2000
Active Comparator: Evanston, Highland Park, Skokie Hospitals

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)

Device: Disinfecting Cap
Replace standard practice with using the disinfecting cap
Other Name: SwabCap SC003 2000

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01301300

Locations
United States, Illinois
NorthShore: Evanston Hospital Recruiting
Evanston, Illinois, United States, 60201
Contact: Sue Boehm, RN    847-926-5860    sboehm@northshore.org   
Contact: Marc Wright, MS    8475702420    mwright@northshore.org   
NorthShore: Glenbrook Hospital Recruiting
Glenview, Illinois, United States, 60201
Contact: Sue Boehm, RN    847-926-5860    sboehm@northshore.org   
Contact: Marc Wright, MS    8475702420    mwright@northshore.org   
NorthShore: Highland Park Hospital Recruiting
Highland Park, Illinois, United States, 60201
Contact: Sue Boehm, RN    847-926-5860    sboehm@northshore.org   
Contact: Marc Wright, MS    8475702420    mwright@northshore.org   
NorthShore: Skokie Hospital Recruiting
Skokie, Illinois, United States, 60201
Contact: Sue ` Boehm, RN    847-926-5860    sboehm@northshore.org   
Contact: Marc Wright, MS    8475702420      
Sponsors and Collaborators
NorthShore University HealthSystem Research Institute
  More Information

No publications provided

Responsible Party: Lance R Peterson, Associate Hospital Epidemiologist, NorthShore University Health System
ClinicalTrials.gov Identifier: NCT01301300     History of Changes
Other Study ID Numbers: EH10-125
Study First Received: February 22, 2011
Last Updated: February 22, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 20, 2014