BIP CVC Clinical Safety and Performance Study

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02811380
• Other study ID #: 2535-2030-CDOC
• Status: Completed
• Phase: Phase 4
• First received: December 23, 2014
• Last updated: June 21, 2016
• Start date: September 2013
• Est. completion date: January 2015

Study information

• Verified date: June 2016
• Source: Bactiguard AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

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

Intervention

Device:
• BIP CVC
BIP CVC catheterization to minimize risk of infections for venous access during and after elective large surgery
• Uncoated Standard CVC
Standard CVC catheterization for venous access during and after elective large surgery

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital, Dept. of Anesthesia and Intensive Care, Sweden	Stockholm	Huddinge

Sponsors (2)

Lead Sponsor	Collaborator
Bactiguard AB	Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through study completion, an average of 10 days	Yes
Secondary	Assessment of the overall performance	Overall assessment of device performance by evaluation of any CVC handling problems experienced by the physician/health care personnel.	Through study completion, an average of 10 days	No