Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-02-10 @ 10:50 PM
Study NCT ID:
NCT02134769
Status:
COMPLETED
Last Update Posted:
2016-11-15
First Post:
2014-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Bionecteurs on Catheter-associated Infection
Sponsor:
University Hospital Tuebingen
Organization:
Study Overview
Official Title:
Incidence of Catheter-related Bloodstream Infections Using Bionecteur Device
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Bionect
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.
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ZVK-Bionect | OTHER | University Hospital Tuebingen | View |