Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties: Efficacy and Effect of Intensive Catheter and Exit Site Care Education

Conditions
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Renal Insufficiency

Intervention / Treatment
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* Device: GamCath® central venous catheter
* Device: GamCath Dolphin® Protect central venous catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>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<br>* choice of catheter type<br>* Other names: GamCath® catheter, No. CE 76891;|
| Experimental: B<br>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<br>* choice of catheter type<br>* Other names: GamCath Dolphin® Protect, No.CE 90671;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial colonisation of the catheter surface |  | at explantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surface deposits of thrombogenic activity |  | at explantation | 
| Catheter survival |  | at explantation | 
| Exit site appearance |  | at routine catheter care | 
| Blood parameters |  | during dialysis | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal Dialysis, Dialysis, Extracorporeal, Dialysis, Renal, Extracorporeal Dialysis