Recruiting
Phase 1
Phase 2

Observational Study

Sponsor:

Endeavor Health

Code:

NCT01301300

Conditions

Catheter-related Bloodstream Infection Due to Central Venous Catheter

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Disinfecting Cap

Study Details

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.

Conditions

Catheter-related Bloodstream Infection Due to Central Venous Catheter

Study ID

NCT01301300

Start date

Apr, 2010

Status verified date

Feb, 2011

Completion date

Dec, 2011

Anticipated

Primary completion date

Sep, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

600 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Glenbrook Hospital

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

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)

Interventions

Disinfecting Cap

Replace standard practice with using the disinfecting cap

Primary outcome measure

  • 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.) ]

Central Contacts and Locations

Locations

NorthShore: Evanston Hospital

Recruiting

Evanston, Illinois, United States, 60201

Contacts

Sue Boehm, RN

847-926-5860sboehm@northshore.org

Marc Wright, MS

8475702420mwright@northshore.org

NorthShore: Glenbrook Hospital

Recruiting

Glenview, Illinois, United States, 60201

Contacts

Sue Boehm, RN

847-926-5860sboehm@northshore.org

Marc Wright, MS

8475702420mwright@northshore.org

NorthShore: Highland Park Hospital

Recruiting

Highland Park, Illinois, United States, 60201

Contacts

Sue Boehm, RN

847-926-5860sboehm@northshore.org

Marc Wright, MS

8475702420mwright@northshore.org

NorthShore: Skokie Hospital

Recruiting

Skokie, Illinois, United States, 60201

Contacts

Sue ' Boehm, RN

847-926-5860sboehm@northshore.org

Marc Wright, MS

8475702420

More Information

Sponsor

Endeavor Health

Last update posted

Feb 23, 2011

Last verified

Feb, 2011

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Endeavor Health on 2011-02-23.