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Clinical Trial 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.


Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT02134769
Study type Interventional
Source University Hospital Tuebingen
Contact
Status Completed
Phase N/A
Start date August 2014
Completion date December 2015

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