search
Back to results

BIP CVC Clinical Safety and Performance Study

Primary Purpose

Surgery, Central Line Associated Blood Stream Infections (CLABSI)

Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
BIP CVC
Uncoated Standard CVC
Sponsored by
Bactiguard AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Surgery focused on measuring CVC, Healthcare associated infections (HAI), CLABSI, Noble metal alloy coating, CVC related thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BIP CVC

Uncoated standard CVC

Arm Description

Bactiguard Infection Protection Central Venous Catheter

Uncoated standard Central Venous Catheter

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 23, 2014
Last Updated
June 21, 2016
Sponsor
Bactiguard AB
Collaborators
Karolinska University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02811380
Brief Title
BIP CVC Clinical Safety and Performance Study
Official Title
Evaluation of Safety and Performance of the BIP Central Venous Catheter With Anti-infective Coating
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bactiguard AB
Collaborators
Karolinska University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Central Line Associated Blood Stream Infections (CLABSI)
Keywords
CVC, Healthcare associated infections (HAI), CLABSI, Noble metal alloy coating, CVC related thrombosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BIP CVC
Arm Type
Experimental
Arm Description
Bactiguard Infection Protection Central Venous Catheter
Arm Title
Uncoated standard CVC
Arm Type
Placebo Comparator
Arm Description
Uncoated standard Central Venous Catheter
Intervention Type
Device
Intervention Name(s)
BIP CVC
Other Intervention Name(s)
BIP Central Venous Catheter, Bactiguard coated CVC, Noble metal alloy coated Central Venous Catheter
Intervention Description
BIP CVC catheterization to minimize risk of infections for venous access during and after elective large surgery
Intervention Type
Device
Intervention Name(s)
Uncoated Standard CVC
Other Intervention Name(s)
Standard CVC, Standard Central Venous Catheter, Uncoated CVC, Uncoated Central Venous Catheter
Intervention Description
Standard CVC catheterization for venous access during and after elective large surgery
Primary Outcome Measure Information:
Title
Assessment of safety by evaluation of CVC related adverse events and any problems in post operative course.
Description
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 Outcome Measure Information:
Title
Assessment of the overall performance
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sigridur Kalman, MD PhD Prof
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital, Dept. of Anesthesia and Intensive Care, Sweden
City
Stockholm
State/Province
Huddinge
ZIP/Postal Code
SE-141 86
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

BIP CVC Clinical Safety and Performance Study

We'll reach out to this number within 24 hrs