Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties
2 other identifiers
interventional
90
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 31, 2008
CompletedFirst Posted
Study publicly available on registry
February 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedMarch 13, 2025
March 1, 2025
3.2 years
January 31, 2008
March 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bacterial colonisation of the catheter surface
at explantation
Secondary Outcomes (4)
Surface deposits of thrombogenic activity
at explantation
Catheter survival
at explantation
Exit site appearance
at routine catheter care
Blood parameters
during dialysis
Study Arms (2)
A
ACTIVE COMPARATORPatients 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).
B
EXPERIMENTALPatients 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).
Interventions
choice of catheter type
choice of catheter type
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vantive Health LLClead
- Gambro Dialysatoren GmbHcollaborator
- Baxter Healthcare Corporationcollaborator
Study Sites (1)
St. Joseph-Krankenhaus Berlin
Berlin, 12101, Germany
Related Publications (1)
Schults JA, Kleidon T, Charles K, Young ER, Ullman AJ. Peripherally inserted central catheter design and material for reducing catheter failure and complications. Cochrane Database Syst Rev. 2024 Jun 28;6(6):CD013366. doi: 10.1002/14651858.CD013366.pub2.
PMID: 38940297DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christiane M Erley, Prof. Dr.
St. Joseph-Krankenhaus Berlin
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2008
First Posted
February 22, 2008
Study Start
October 1, 2007
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
March 13, 2025
Record last verified: 2025-03