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Study on the Infection Risk of Long Dwell Period Catheters in High Risk Intensive Care Unit (ICU) Patients

Primary Purpose

Burns

Status

Terminated

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Placement of a silver impregnated central venous catheter

About this trial

This is an interventional treatment trial for Burns focused on measuring colonisation of the catheter

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Burn patient Placement of a new trilumen central venous catheter

Sites / Locations

University Hospital Ghent

Outcomes

Primary Outcome Measures

Degree of colonisation of the central venous catheter at the moment of removal

Secondary Outcome Measures

Incidence of a catheter related blood stream infection during the presence of the catheter

Full Information

NCT ID

NCT00136097

First Posted

August 25, 2005

Last Updated

December 19, 2007

Sponsor

University Hospital, Ghent

1. Study Identification

Unique Protocol Identification Number

NCT00136097

Brief Title

Study on the Infection Risk of Long Dwell Period Catheters in High Risk Intensive Care Unit (ICU) Patients

Official Title

Study on the Infection Risk of Long Dwell Period Catheters in High Risk ICU Patients

Study Type

Interventional

2. Study Status

Record Verification Date

December 2007

Overall Recruitment Status

Terminated

Study Start Date

August 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Ghent

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is an evaluation of the use of silver impregnated catheters in burn patients to reduce catheter colonisation compared to the standard central venous catheter without antiseptic activity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Burns

Keywords

colonisation of the catheter

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Double

Allocation

Randomized

Enrollment

142 (false)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Placement of a silver impregnated central venous catheter

Primary Outcome Measure Information:

Title

Degree of colonisation of the central venous catheter at the moment of removal

Secondary Outcome Measure Information:

Title

Incidence of a catheter related blood stream infection during the presence of the catheter

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Burn patient Placement of a new trilumen central venous catheter

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kirsten Colpaert, MD

Organizational Affiliation

University Hospital, Ghent

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Ghent

City

Ghent

ZIP/Postal Code

9000

Country

Belgium

12. IPD Sharing Statement

Links:

URL

http://www.uzgent.be

Description

Website University Hospital Ghent

Learn more about this trial

Study on the Infection Risk of Long Dwell Period Catheters in High Risk Intensive Care Unit (ICU) Patients

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