Trials Sponsors Conditions Drugs Pricing

Conditions

Central Line Associated Blood Stream Infections (CLABSI)Surgery

Keywords

CVCHealthcare associated infections (HAI)CLABSINoble metal alloy coatingCVC related thrombosis

Outcome Measures

Primary Outcomes (1)

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.
Through study completion, an average of 10 days

Secondary Outcomes (1)

Assessment of the overall performance
Through study completion, an average of 10 days

Study Arms (2)

BIP CVC

EXPERIMENTAL

Bactiguard Infection Protection Central Venous Catheter

Device: BIP CVC

Uncoated standard CVC

PLACEBO COMPARATOR

Uncoated standard Central Venous Catheter

Device: Uncoated Standard CVC

Interventions

BIP CVCDevice

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

Also known as: BIP Central Venous Catheter, Bactiguard coated CVC, Noble metal alloy coated Central Venous Catheter

BIP CVC

Uncoated Standard CVCDevice

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

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

Karolinska University Hospital
Othercollaborator
Bactiguard AB
Industrylead

Study Sites (1)

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

Stockholm, Huddinge, SE-141 86, Sweden

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Sigridur Kalman, MD PhD Prof
Karolinska University Hospital
PRINCIPAL INVESTIGATOR

Enrollment

36 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Purpose: SUPPORTIVE CARE
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 23, 2014

First Posted

June 23, 2016

Study Start

September 2013

Date type not reported

This date has not been verified as actual or estimated.

BIP CVC Clinical Safety and Performance Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

Primary Completion

Study Completion

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

BIP CVC

Uncoated standard CVC

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

Primary Completion

Study Completion

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

BIP CVC

Uncoated standard CVC

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations