Influence of Bionecteurs on Catheter-associated Infection (Bionect)

November 11, 2016 updated by: University Hospital Tuebingen

Incidence of Catheter-related Bloodstream Infections Using Bionecteur Device

Bionecteur® is a protective non-touch applicator to ensure aseptic connection made by Vygon. However, there are no studies describing a positive effect of using Bionecteurs ® in regard to catheter-related bloodstream infections. In this study Bionecteur® will be used on central venous lines and arterial lines in postoperative patients of a 40-bed ICU. The incidence of catheter-related bloodstream infections will we compared to patients without inclusion of Bionecteur® devices.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • Prospective, randomised observational study

  • Postsurgical patients in an anesthesiological ICU with ICU LOS (LOS: length of stay) > 3 days

    • Inclusion:

      ---- Age ≥ 18 years

      ---. demand of central venous and arterial line

      --- written consent of patient and/or assignee

    • Exclusion

      • Handicapped patients
      • patient with ICU LOS < 3 days

  • Study design

    1. Three days after admission to ICU blood cultures are drawn to exclude preexisting blood stream infection
    2. Patients in a bed with even number are assigned to Bionecteur® group. Control group (without using bionecteurs) are patients with an odd bed number.
    3. Biconecteurs® are connected to all lumens of the central catheter and to arterial catheter. Control group is treated without using Bionecteurs®. Handling of vascular catheters are performed as described in institutional guidelines in both groups.
    4. Catheter-related bloodstream infections are monitored by an independent person during ICU treatment
    5. The study will be finished ab discharge of ICU or removal of catheters.

Study Type

Interventional

Enrollment (Actual)

221

Phase

  • Not Applicable

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
      • Tuebingen, Germany, 72076
        • University Hospital Tuebingen

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Length of Stay (LOS) in ICU > 3 days
  • written consent by patient or notarial carers
  • medical indication for central venous line/arterial line

Exclusion Criteria:

  • handicap
  • LOS ICU < 3 days
  • no consent

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No use of Bionecteur; handling according to institutional guideline
Active Comparator: Bionecteur
Use of Bionecteur; handling according to institutional guideline
Device: Bionecteur
Using Bionecteur at each lumina of the catheter; handling according to institutional guideline
Other Names:
  • bionector® company: Vygon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of catheter-related bloodstream infections using Bionecteurs
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Stay in ICU
Time Frame: 1 year
Determine days in ICU with centrral venous catheter
1 year

Collaborators and Investigators

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

Sponsor

University Hospital Tuebingen

Collaborators

Vygon GmbH & Co. KG

Investigators

  • Principal Investigator: Helene A Haeberle, MD, University Hospital Tuebingen, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

April 9, 2014

First Submitted That Met QC Criteria

May 7, 2014

First Posted (Estimate)

May 9, 2014

Study Record Updates

Last Update Posted (Estimate)

November 15, 2016

Last Update Submitted That Met QC Criteria

November 11, 2016

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIONECT-2014
  • ZVK-Bionect (Other Identifier: University Hospital Tuebingen)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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