Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties

Vantive Health LLC

Status: Completed

Conditions: Renal Insufficiency

Treatments: Device: GamCath Dolphin® Protect central venous catheter; Device: GamCath® central venous catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT00621712

Study No 2007_MBR_001

ISRCTN93939200 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups

A

Active Comparator group

Description:

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).

Treatment:

Device: GamCath® central venous catheter

B

Experimental group

Description:

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).

Treatment:

Device: GamCath Dolphin® Protect central venous catheter