Influence of Bionecteurs on Catheter-associated Infection

Infection Clinical Trial

— Bionect  

Official title:

Incidence of Catheter-related Bloodstream Infections Using Bionecteur Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02134769
• Other study ID #: BIONECT-2014
• Secondary ID: ZVK-Bionect
• Status: Completed
• Phase: N/A
• First received: April 9, 2014
• Last updated: November 11, 2016
• Start date: August 2014
• Est. completion date: December 2015

Study information

• Verified date: July 2015
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection

Intervention

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

Locations

Country	Name	City	State
Germany	University Hospital Tuebingen	Tuebingen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Vygon GmbH & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of catheter-related bloodstream infections using Bionecteurs		1 year	Yes
Secondary	Length of Stay in ICU	Determine days in ICU with centrral venous catheter	1 year	Yes