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Influence of Bionecteurs on Catheter-associated Infection

Incidence of Catheter-related Bloodstream Infections Using Bionecteur Device

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02134769
Acronym
Bionect
Enrollment
221
Registered
2014-05-09
Start date
2014-08-31
Completion date
2015-12-31
Last updated
2016-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection

Keywords

catheter-related bloodstream infections

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.

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.

Interventions

DEVICEBionecteur

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

Sponsors

Vygon GmbH & Co. KG
CollaboratorINDUSTRY
University Hospital Tuebingen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Incidence of catheter-related bloodstream infections using Bionecteurs1 year

Secondary

MeasureTime frameDescription
Length of Stay in ICU1 yearDetermine days in ICU with centrral venous catheter

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026