Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties
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|ClinicalTrials.gov Identifier: NCT00621712|
Recruitment Status : Completed
First Posted : February 22, 2008
Last Update Posted : April 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Renal Insufficiency||Device: GamCath® central venous catheter Device: GamCath Dolphin® Protect central venous catheter||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties: Efficacy and Effect of Intensive Catheter and Exit Site Care Education|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
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
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
- Bacterial colonisation of the catheter surface [ Time Frame: at explantation ]
- 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 ]
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
|St. Joseph-Krankenhaus Berlin|
|Berlin, Germany, 12101|
|Principal Investigator:||Christiane M Erley, Prof. Dr.||St. Joseph-Krankenhaus Berlin|