NCT02134769

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
221

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 9, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

November 15, 2016

Status Verified

July 1, 2015

Enrollment Period

1.3 years

First QC Date

April 9, 2014

Last Update Submit

November 11, 2016

Conditions

Infection

Keywords

catheter-related bloodstream infections

Outcome Measures

Primary Outcomes (1)

  • Incidence of catheter-related bloodstream infections using Bionecteurs

    1 year

Secondary Outcomes (1)

  • Length of Stay in ICU

    1 year

Study Arms (2)

Control

NO INTERVENTION

No use of Bionecteur; handling according to institutional guideline

Bionecteur

ACTIVE COMPARATOR

Use of Bionecteur; handling according to institutional guideline

Device: Bionecteur

Interventions

BionecteurDEVICE

Using Bionecteur at each lumina of the catheter; handling according to institutional guideline

Also known as: bionector® company: Vygon
Bionecteur

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • handicap
  • LOS ICU \< 3 days
  • no consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Tuebingen

Tübingen, 72076, Germany

Location

Related Publications (1)

  • Koeppen M, Weinert F, Oehlschlaeger S, Koerner A, Rosenberger P, Haeberle HA. Needle-free connectors catheter-related bloodstream infections: a prospective randomized controlled trial. Intensive Care Med Exp. 2019 Dec 2;7(1):63. doi: 10.1186/s40635-019-0277-7.

    PMID: 31792889DERIVED

MeSH Terms

Conditions

Infections

Study Officials

  • Helene A Haeberle, MD

    University Hospital Tuebingen, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2014

First Posted

May 9, 2014

Study Start

August 1, 2014

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

November 15, 2016

Record last verified: 2015-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)