Influence of Bionecteurs on Catheter-associated Infection

University Hospital Tuebingen

Status: Completed

Conditions: Infection

Treatments: Device: Bionecteur

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02134769

ZVK-Bionect (Other Identifier)

BIONECT-2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 221 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

221 participants in 2 patient groups

Control

No Intervention group

Description:

No use of Bionecteur; handling according to institutional guideline

Bionecteur

Active Comparator group

Description:

Use of Bionecteur; handling according to institutional guideline

Treatment:

Device: Bionecteur