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BIP CVC Clinical Safety and Performance Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02811380
Recruitment Status : Completed
First Posted : June 23, 2016
Last Update Posted : June 23, 2016
Sponsor:
Collaborator:
Karolinska University Hospital
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Surgery Central Line Associated Blood Stream Infections (CLABSI) Device: BIP CVC Device: Uncoated Standard CVC Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Evaluation of Safety and Performance of the BIP Central Venous Catheter With Anti-infective Coating
Study Start Date : September 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811380


Locations
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Sweden
Karolinska University Hospital, Dept. of Anesthesia and Intensive Care, Sweden
Stockholm, Huddinge, Sweden, SE-141 86
Sponsors and Collaborators
Bactiguard AB
Karolinska University Hospital
Investigators
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Principal Investigator: Sigridur Kalman, MD PhD Prof Karolinska University Hospital
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Responsible Party: Bactiguard AB
ClinicalTrials.gov Identifier: NCT02811380    
Other Study ID Numbers: 2535-2030-CDOC
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Bactiguard AB:
CVC
Healthcare associated infections (HAI)
CLABSI
Noble metal alloy coating
CVC related thrombosis
Additional relevant MeSH terms:
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Infection