NCT02811380

BIP CVC Clinical Safety and Performance Study

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Bactiguard AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgery
• Central Line Associated Blood Stream Infections (CLABSI)

Interventions

Type	Name	Description
DEVICE	BIP CVC	BIP CVC catheterization to minimize risk of infections for venous access during and after elective large surgery
DEVICE	Uncoated Standard CVC	Standard CVC catheterization for venous access during and after elective large surgery

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2016-06-23
• Last updated: 2016-06-23

Locations

1 site across 1 country: Sweden