- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00621712
Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties
Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties: Efficacy and Effect of Intensive Catheter and Exit Site Care Education
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Berlin, Germany, 12101
- St. Joseph-Krankenhaus Berlin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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).
|
choice of catheter type
Other Names:
|
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).
|
choice of catheter type
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bacterial colonisation of the catheter surface
Time Frame: at explantation
|
at explantation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Surface deposits of thrombogenic activity
Time Frame: at explantation
|
at explantation
|
Catheter survival
Time Frame: at explantation
|
at explantation
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Exit site appearance
Time Frame: at routine catheter care
|
at routine catheter care
|
Blood parameters
Time Frame: during dialysis
|
during dialysis
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christiane M Erley, Prof. Dr., St. Joseph-Krankenhaus Berlin
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Study No 2007_MBR_001
- ISRCTN93939200 (Registry Identifier: ISRCTN)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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