Central Line Associated Blood Stream Infections (CLABSI), Surgery
Conditions
Keywords
CVC, Healthcare associated infections (HAI), CLABSI, Noble metal alloy coating, CVC related thrombosis
Brief summary
The primary objective of this trial was to determine Bactiguard coated BIP CVC's safety and performance and compare it to corresponding standard uncoated CVC.
Detailed description
The primary objective of this study is to determine the safety for the medical device of 'BIP central venous catheter. Safety is assessed by evaluation of adverse events (according to ISO 14155:2011). Examples of CVC related common events are phlebitis, infection at the infection site, catheter related bacteremia/fungemia, septicemia, sepsis, thrombosis, lung emboli and pneumothorax. The secondary objective is to assess the overall performance by evaluating if there were any CVC handling problems experienced by the physician/health care personnel. Furthermore, an exploratory objective of this study is to assess coating and microbial colonization. Included in the study were men and women aged 18 years or older undergoing elective standardized large surgery with a planned CVC catheterization in right or left jugular vein or subclavian vein planned for at least 3 days. This study is a single-centre, randomized, single-blind, controlled study of tolerability and safety of BIP CVC with noble metal alloy coating. All statistical analyses is performed using the SAS® System, version 9.3 or higher (SAS Institute Inc., Cary, NC, USA). Data is to be summarized using descriptive statistics.
Interventions
DEVICEBIP CVC
BIP CVC catheterization to minimize risk of infections for venous access during and after elective large surgery
DEVICEUncoated Standard CVC
Standard CVC catheterization for venous access during and after elective large surgery
Sponsors
Karolinska University Hospital
Bactiguard AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult men and women ≥ 18 years of age * Were, in the opinion of the investigator, able to communicate with and understand the trial personnel and comply with the requirements of the trial * Requiring CVC catheterization for venous access, via right (most often) or left jugular vein or subclavian vein, during and after elective large surgery (liver or pancreas resection or intestinal/bowel surgery) planned for at least 3 days * Had signed the informed consent
Exclusion criteria
* Known transmissive blood disease * Known multiresistant bacterial colonization * Ongoing infection * Thromboembolism * Anti-coagulation treatment excluding prophylaxis * CVC during last 2 months * History of problems with CVC * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of safety by evaluation of CVC related adverse events and any problems in post operative course. | Through study completion, an average of 10 days | Overall assessment of safety by evaluation of CVC related adverse events and any problems in post operative course. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the overall performance | Through study completion, an average of 10 days | Overall assessment of device performance by evaluation of any CVC handling problems experienced by the physician/health care personnel. |
Countries
Sweden
Outcome results
None listed