BIP CVC Clinical Safety and Performance Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Safety and Performance of the BIP Central Venous Catheter With Anti-infective Coating

Conditions
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Surgery, Central Line Associated Blood Stream Infections (CLABSI)

Intervention / Treatment
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* Device: BIP CVC
* Device: Uncoated Standard CVC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIP CVC<br>Bactiguard Infection Protection Central Venous Catheter | Device: BIP CVC<br>* BIP CVC catheterization to minimize risk of infections for venous access during and after elective large surgery<br>* Other names: Noble metal alloy coated Central Venous Catheter;|
| Placebo Comparator: Uncoated standard CVC<br>Uncoated standard Central Venous Catheter | Device: Uncoated Standard CVC<br>* Standard CVC catheterization for venous access during and after elective large surgery<br>* Other names: Uncoated Central Venous Catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of safety by evaluation of CVC related adverse events and any problems in post operative course. | Overall 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the overall performance | Overall assessment of device performance by evaluation of any CVC handling problems experienced by the physician/health care personnel. | Through study completion, an average of 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CVC, Healthcare associated infections (HAI), CLABSI, Noble metal alloy coating, CVC related thrombosis