Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties
|Renal Insufficiency||Device: GamCath® central venous catheter Device: GamCath Dolphin® Protect central venous catheter|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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|
- 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 ]
|Study Start Date:||October 2007|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00621712
|St. Joseph-Krankenhaus Berlin|
|Berlin, Germany, 12101|
|Principal Investigator:||Christiane M Erley, Prof. Dr.||St. Joseph-Krankenhaus Berlin|