Surgery Clinical Trial
Official title:
Evaluation of Safety and Performance of the BIP Central Venous Catheter With Anti-infective Coating
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
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