BIP CVC Clinical Safety and Performance Study

Bactiguard

Status and phase: Completed; Phase 4

Conditions: Surgery; Central Line Associated Blood Stream Infections (CLABSI)

Treatments: Device: BIP CVC; Device: Uncoated Standard CVC

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02811380

2535-2030-CDOC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups, including a placebo group

BIP CVC

Experimental group

Description:

Bactiguard Infection Protection Central Venous Catheter

Treatment:

Device: BIP CVC

Uncoated standard CVC

Placebo Comparator group

Description:

Uncoated standard Central Venous Catheter

Treatment:

Device: Uncoated Standard CVC