BIP CVC Clinical Safety and Performance Study

Phase 4

Completed

• Conditions: Surgery; Central Line Associated Blood Stream Infections (CLABSI)
• Interventions: Device: Uncoated Standard CVC; Device: BIP CVC

• Registration Number: NCT02811380
• Lead Sponsor: Bactiguard AB

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-12-23
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2016-06
• Study First Submitted QC: 2016-06-21
• Last Update Submitted: 2016-06-21
• Study First Posted: 2016-06-23
• Last Update Posted: 2016-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Uncoated standard CVC	Uncoated Standard CVC	Uncoated standard Central Venous Catheter
BIP CVC	BIP CVC	Bactiguard Infection Protection Central Venous Catheter

Primary Outcome Measures

Name	Time	Method
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	Overall assessment of safety by evaluation of CVC related adverse events and any problems in post operative course.

Secondary Outcome Measures

Name	Time	Method
Assessment of the overall performance	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.

Trial Locations

Locations (1)

Karolinska University Hospital, Dept. of Anesthesia and Intensive Care, Sweden; 🇸🇪 Stockholm, Huddinge, Sweden