BIP CVC Clinical Safety and Performance Study

Bactiguard AB36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Surgery Central Line Associated Blood Stream Infections (CLABSI)

Interventions

BIP CVCDEVICE

BIP CVC catheterization to minimize risk of infections for venous access during and after elective large surgery

Uncoated Standard CVCDEVICE

Standard CVC catheterization for venous access during and after elective large surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Karolinska University Hospital, Dept. of Anesthesia and Intensive Care, Sweden

Stockholm, Huddinge, Sweden

Outcomes

Primary Outcomes

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.

Time frame: Through study completion, an average of 10 days

Secondary Outcomes

Assessment of the overall performance

Overall assessment of device performance by evaluation of any CVC handling problems experienced by the physician/health care personnel.

Time frame: Through study completion, an average of 10 days

Data from ClinicalTrials.gov

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