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Sponsored by: |
Gambro Dialysatoren GmbH |
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Information provided by: | Gambro Dialysatoren GmbH |
ClinicalTrials.gov Identifier: | NCT00621712 |
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 |
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Hemodialysis |
Device: GamCath® central venous catheter Device: GamCath Dolphin® Protect central venous catheter |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study |
Official Title: | Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties: Efficacy and Effect of Intensive Catheter and Exit Site Care Education |
Estimated Enrollment: | 180 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
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).
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Device: GamCath® central venous catheter
choice of catheter type
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B: Experimental
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).
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Device: GamCath Dolphin® Protect central venous catheter
choice of catheter type
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Heike B Lebsanft, Dr. | +49 (0) 7471 17 -0 ext 2008 | Heike.Lebsanft@Gambro.com |
Contact: Werner Beck, Dr. | +49 (0) 7471 17 -0 ext 1259 | Werner.Beck@Gambro.com |
Germany | |
St. Joseph-Krankenhaus Berlin | Recruiting |
Berlin, Germany, 12101 | |
Contact: Christiane M Erley, Prof. Dr. ++49 30-7882- 0 ext -2379 Christiane.Erley@sjk.de | |
Contact: Birgit D Bader, Dr. med. ++49 30- 7882 - 0 ext -2168 Birgit.Bader@sjk.de | |
Principal Investigator: Christiane M Erley, Prof. Dr. | |
Sub-Investigator: Birgit D Bader, Dr. med. |
Principal Investigator: | Christiane M Erley, Prof. Dr. | St. Joseph-Krankenhaus Berlin |
Responsible Party: | Gambro Dialysatoren GmbH ( Manager Clinical Research ) |
Study ID Numbers: | Study No 2007_MBR_001, ISRCTN93939200 |
Study First Received: | January 31, 2008 |
Last Updated: | October 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00621712 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Renal Dialysis Dialysis, Extracorporeal Dialysis, Renal Extracorporeal Dialysis |