BIP CVC Clinical Safety and Performance Study
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|ClinicalTrials.gov Identifier: NCT02811380|
Recruitment Status : Completed
First Posted : June 23, 2016
Last Update Posted : June 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|Surgery Central Line Associated Blood Stream Infections (CLABSI)||Device: BIP CVC Device: Uncoated Standard CVC||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Evaluation of Safety and Performance of the BIP Central Venous Catheter With Anti-infective Coating|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
Experimental: BIP CVC
Bactiguard Infection Protection Central Venous Catheter
Device: BIP CVC
BIP CVC catheterization to minimize risk of infections for venous access during and after elective large surgery
Placebo Comparator: Uncoated standard CVC
Uncoated standard Central Venous Catheter
Device: Uncoated Standard CVC
Standard CVC catheterization for venous access during and after elective large surgery
- Assessment of safety by evaluation of CVC related adverse events and any problems in post operative course. [ Time Frame: 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.
- Assessment of the overall performance [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811380
|Karolinska University Hospital, Dept. of Anesthesia and Intensive Care, Sweden|
|Stockholm, Huddinge, Sweden, SE-141 86|
|Principal Investigator:||Sigridur Kalman, MD PhD Prof||Karolinska University Hospital|