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

NCT04534348 | Completed FDA Device

• 1 other identifier: STERILE
• Study Type: observational
• Target: 598
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

CLABSI - Central Line Associated Bloodstream Infection; Catheter-Related Blood Stream Infection

Keywords

CLABSI; CRBSI; Blood Stream Infection

Outcome Measures

Primary Outcomes (1)

• Number of CLABSI

  To assess the clinical efficacy of Curos in preventing CLABSI in a high-risk department (oncology and ICU)

  12 Months

Study Arms (2)

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

Interventions

70% isopropyl alcohol-impregnated catheter caps DEVICE

Implementation of 70% isopropyl alcohol-impregnated catheter caps in order to assess the number of CLABSI diagnosed during 1 Year

Also known as: CUROS (3M), self disinfecting catheter caps

CUROS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

University Hospital of Cologne

Cologne, 50937, Germany

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. MD

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 1, 2020
• Study Start: November 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: January 31, 2020
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)