BIP CVC Clinical Safety and Performance Study

June 21, 2016 updated by: Bactiguard AB

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Huddinge
      • Stockholm, Huddinge, Sweden, SE-141 86
        • Karolinska University Hospital, Dept. of Anesthesia and Intensive Care, Sweden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BIP CVC
Bactiguard Infection Protection Central Venous Catheter
Device: BIP CVC
BIP CVC catheterization to minimize risk of infections for venous access during and after elective large surgery
Other Names:
  • BIP Central Venous Catheter
  • Bactiguard coated CVC
  • Noble metal alloy coated Central Venous Catheter
Placebo Comparator: Uncoated standard CVC
Uncoated standard Central Venous Catheter
Device: Uncoated Standard CVC
Standard CVC catheterization for venous access during and after elective large surgery
Other Names:
  • Standard CVC
  • Standard Central Venous Catheter
  • Uncoated CVC
  • Uncoated Central Venous Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the overall performance
Time Frame: 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.
Through study completion, an average of 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bactiguard AB

Collaborators

Karolinska University Hospital

Investigators

  • Principal Investigator: Sigridur Kalman, MD PhD Prof, Karolinska University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

December 23, 2014

First Submitted That Met QC Criteria

June 21, 2016

First Posted (Estimate)

June 23, 2016

Study Record Updates

Last Update Posted (Estimate)

June 23, 2016

Last Update Submitted That Met QC Criteria

June 21, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2535-2030-CDOC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Surgery

Clinical Trials on BIP CVC

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe