Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties

This study has been completed.
Sponsor:
Information provided by:
Gambro Dialysatoren GmbH
ClinicalTrials.gov Identifier:
NCT00621712
First received: January 31, 2008
Last updated: March 7, 2011
Last verified: March 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Gambro Dialysatoren GmbH:

Primary Outcome Measures:
  • Bacterial colonisation of the catheter surface [ Time Frame: at explantation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Surface deposits of thrombogenic activity [ Time Frame: at explantation ] [ Designated as safety issue: No ]
  • Catheter survival [ Time Frame: at explantation ] [ Designated as safety issue: No ]
  • Exit site appearance [ Time Frame: at routine catheter care ] [ Designated as safety issue: No ]
  • Blood parameters [ Time Frame: during dialysis ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621712

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

No publications provided

Responsible Party: Manager Clinical Research, Gambro Dialysatoren GmbH
ClinicalTrials.gov Identifier: NCT00621712     History of Changes
Other Study ID Numbers: Study No 2007_MBR_001, ISRCTN93939200
Study First Received: January 31, 2008
Last Updated: March 7, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Gambro Dialysatoren GmbH:
Renal Dialysis
Dialysis, Extracorporeal
Dialysis, Renal
Extracorporeal Dialysis

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014