Clinical trial NCT02811380: BIP CVC Clinical Safety and Performance Study
Official title: Evaluation of Safety and Performance of the BIP Central Venous Catheter With Anti-infective Coating
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Surgery
Central Line Associated Blood Stream Infections (CLABSI)
Keywords: CVC
Healthcare associated infections (HAI)
CLABSI
Noble metal alloy coating
CVC related thrombosis
Lead sponsor: Bactiguard AB
Sponsor class: INDUSTRY
Collaborators: name: Karolinska University Hospital
First posted: 2016-06-23
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of safety by evaluation of CVC related adverse events and any problems in post operative course.
timeFrame: Through study completion, an average of 10 days
Secondary outcomes:
measure: Assessment of the overall performance
timeFrame: Through study completion, an average of 10 days
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital, Dept. of Anesthesia and Intensive Care, Sweden
state: Huddinge
Study officials:
affiliation: Karolinska University Hospital
name: Sigridur Kalman, MD PhD Prof
role: PRINCIPAL_INVESTIGATOR
References: