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Completed

NCT Number: NCT02134769

Influence of Bionecteurs on Catheter-associated Infection

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.

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Key information

Conditions

Infection Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Tuebingen

Tübingen, 72076, Germany

About this study

  • 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
  • Three days after admission to ICU blood cultures are drawn to exclude preexisting blood stream infection
  • Patients in a bed with even number are assigned to Bionecteur® group. Control group (without using bionecteurs) are patients with an odd bed number.
  • 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.
  • Catheter-related bloodstream infections are monitored by an independent person during ICU treatment
  • The study will be finished ab discharge of ICU or removal of catheters.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bionecteur

Device

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

Other names: bionector® company: Vygon

Primary outcomes

  1. Incidence of catheter-related bloodstream infections using Bionecteurs

    Time frame: 1 year

Secondary outcomes

  1. Length of Stay in ICU

    Time frame: 1 year

    Determine days in ICU with centrral venous catheter

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

  • Vygon GmbH & Co. KG

Registry information

Official study title

Incidence of Catheter-related Bloodstream Infections Using Bionecteur Device

Acronym: Bionect

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 9, 2014
Registry last updated
Nov 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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