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BIP CVC Clinical Safety and Performance Study

NCT02811380 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2016-06-23

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

BIP CVC

BIP CVC catheterization to minimize risk of infections for venous access during and after elective large surgery

DEVICE

Uncoated Standard CVC

Standard CVC catheterization for venous access during and after elective large surgery

Sponsors & Collaborators

  • Karolinska University Hospital

    collaborator OTHER

  • Bactiguard AB

    lead INDUSTRY

Principal Investigators

  • Sigridur Kalman, MD PhD Prof · Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02811380 on ClinicalTrials.gov