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Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00621712
First Posted: February 22, 2008
Last Update Posted: April 20, 2017
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.
Collaborator:
Gambro Dialysatoren GmbH
Information provided by (Responsible Party):
Baxter Healthcare Corporation
  Purpose
The study investigates the efficacy of a catheter with antibacterial surface coating in preventing central venous catheter related infection and the effect of an intensive hygiene and catheter care education of the nursing staff on preventing central venous catheter-related infection.

Condition Intervention
Renal Insufficiency Device: GamCath® central venous catheter Device: GamCath Dolphin® Protect central venous catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties: Efficacy and Effect of Intensive Catheter and Exit Site Care Education

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Bacterial colonisation of the catheter surface [ Time Frame: at explantation ]

Secondary Outcome Measures:
  • Surface deposits of thrombogenic activity [ Time Frame: at explantation ]
  • Catheter survival [ Time Frame: at explantation ]
  • Exit site appearance [ Time Frame: at routine catheter care ]
  • Blood parameters [ Time Frame: during dialysis ]

Enrollment: 90
Study Start Date: October 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Patients in group A will be provided with a commercially available and CE certified standard double lumen catheter without surface coating (GamCath® catheter, No. CE 76891).
Device: GamCath® central venous catheter
choice of catheter type
Other Name: GamCath® catheter, No. CE 76891
Experimental: B
Patients in group B will be treated with a CE certified double lumen catheter with a new antibacterial bismuth-containing surface coating (GamCath Dolphin® Protect, No. CE 90671).
Device: GamCath Dolphin® Protect central venous catheter
choice of catheter type
Other Name: GamCath Dolphin® Protect, No.CE 90671

Detailed Description:

The risk of catheter-related bloodstream infection depends on catheter type, method and site of insertion, aseptic technique and number of manipulations. To address this problem, efforts have focused on engineering biomaterials and surfaces with antibacterial properties to prevent bacteria adhesion and biofilm formation.

In view of the necessity to reduce catheter-related bloodstream infections and of the inadequacy of currently available antimicrobially coated devices, a new antimicrobial catheter surface was developed.

Among other factors, the mode and quality of catheter handling and care of exit site is an important aspect with respect to catheter-related infections.

The clinical study aims at providing data on antimicrobial efficiency of the 2 types of CE certified double lumen catheters and a supposed additional preventive effect of intense hygiene training on catheter-related infections.

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • central venous catheter placement
  • Need for extracorporeal renal replacement therapy (acute and chronic renal failure)
  • Age over 18 years
  • Written informed consent
  • Needed catheter length 15 cm or 20 cm

Exclusion Criteria:

  • Known infectivity with Hepatitis B Virus (HBV)/Hepatitis C Virus (HCV)/Human Immunodeficiency Virus (HIV)
  • Any infection associated with one or more positive blood cultures within 10 days prior to catheter implantation
  • Bacteremia with a former catheter within 10 days prior to catheter implantation
  • Known pregnancy
  • Lactation
  • Participation in another clinical study during the preceding 30 days
  Contacts and Locations
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): NCT00621712


Locations
Germany
St. Joseph-Krankenhaus Berlin
Berlin, Germany, 12101
Sponsors and Collaborators
Baxter Healthcare Corporation
Gambro Dialysatoren GmbH
Investigators
Principal Investigator: Christiane M Erley, Prof. Dr. St. Joseph-Krankenhaus Berlin
  More Information

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00621712     History of Changes
Other Study ID Numbers: Study No 2007_MBR_001
ISRCTN93939200 ( Registry Identifier: ISRCTN )
First Submitted: January 31, 2008
First Posted: February 22, 2008
Last Update Posted: April 20, 2017
Last Verified: March 2017

Keywords provided by Baxter Healthcare Corporation:
Renal Dialysis
Dialysis, Extracorporeal
Dialysis, Renal
Extracorporeal Dialysis

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Anti-Infective Agents
Anti-Bacterial Agents