Study on the Reduction of Catheter-related Infections by Use of Self-disinfecting Venous and Arterial Access Caps (STERILE)

August 26, 2020 updated by: Maria J.G.T. Vehreschild, University of Cologne
Observational study on the reduction of catheter-related Infections by use of self-disinfecting venous and arterial access caps (Curos caps ;3M, Saint Paul, MN, USA)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

598

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Cologne, Germany, 50937
        • University Hospital of Cologne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients treated in the hemato-oncological department at the University Clinic in Cologne, Germany, receiving a central-line catheter during one year previous to the implementation of alcohol-impregnated catheter caps as well as all patients receiving a central-line catheter during the 12 months following the implementation of CUROS were included in this study

Description

Inclusion Criteria:

  • every patient in the hemato-oncological department who received at least one CVC was included in the study

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
All central-line-associated blood stream infections (CLABSI) diagnosed during the year previous the implementation of 70% isopropyl alcohol-impregnated Curos catheter caps
CUROS
All central-line-associated blood stream infections (CLABSI) diagnosed during the year after the implementation of 70% isopropyl alcohol-impregnated Curos catheter caps
Device: 70% isopropyl alcohol-impregnated catheter caps
Implementation of 70% isopropyl alcohol-impregnated catheter caps in order to assess the number of CLABSI diagnosed during 1 Year
Other Names:
  • CUROS (3M)
  • self disinfecting catheter caps

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of CLABSI
Time Frame: 12 Months
To assess the clinical efficacy of Curos in preventing CLABSI in a high-risk department (oncology and ICU)
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

January 31, 2020

Study Registration Dates

First Submitted

August 26, 2020

First Submitted That Met QC Criteria

August 26, 2020

First Posted (Actual)

September 1, 2020

Study Record Updates

Last Update Posted (Actual)

September 1, 2020

Last Update Submitted That Met QC Criteria

August 26, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STERILE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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