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BIP CVC Clinical Safety and Performance Study

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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

Tracking Information
First Submitted Date  ICMJE December 23, 2014
First Posted Date  ICMJE June 23, 2016
Last Update Posted Date June 23, 2016
Study Start Date  ICMJE September 2013
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2016)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BIP CVC Clinical Safety and Performance Study
Official Title  ICMJE Evaluation of Safety and Performance of the BIP Central Venous Catheter With Anti-infective Coating
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Surgery
  • Central Line Associated Blood Stream Infections (CLABSI)
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: BIP CVC
    Bactiguard Infection Protection Central Venous Catheter
    Intervention: Device: BIP CVC
  • Placebo Comparator: Uncoated standard CVC
    Uncoated standard Central Venous Catheter
    Intervention: Device: Uncoated Standard CVC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2016)
36
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02811380
Other Study ID Numbers  ICMJE 2535-2030-CDOC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bactiguard AB
Study Sponsor  ICMJE Bactiguard AB
Collaborators  ICMJE Karolinska University Hospital
Investigators  ICMJE
Principal Investigator: Sigridur Kalman, MD PhD Prof Karolinska University Hospital
PRS Account Bactiguard AB
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP