In neutropenic cancer patients, catheter-related bloodstream infections may cause severe infections and even death. To assess the prophylactic effect of a chlorhexidine coated catheter securement dressing on the incidence of catheter-related bloodstream infections, this open, randomized trial is being carried out. CHG iv Tegaderm securement dressing will be randomized in a 1:1 fashion against Tegaderm Advanced iv securement dressing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
630
Patients receive the 3M™ Tegaderm CHG IV securement dressing or the 3M Tegaderm Advanced IV securement dressing after placement of a central venous catheter.
Klinikum Schwabing
Munich, Bavaria, Germany
Klinikum Neuperlach
Munich, Bavaria, Germany
Universitätsklinikum Aachen
Aachen, North Rhine-Westphalia, Germany
University Hospital Cologne
Cologne, North Rhine-Westphalia, Germany
Incidence of definite catheter-related bloodstream infection during the first 14 days after placement of the central venous catheter
Incidence of definite catheter-related bloodstream infection during the first 14 days after placement of the central venous catheter
Time frame: 14 days
Incidence of definite catheter related bloodstream infection-related severe sepsis during the first 14 days after placement of the central venous catheter
Incidence of definite catheter related bloodstream infection-related severe sepsis during the first 14 days after placement of the central venous catheter
Time frame: 14 days
Definite catheter-related bloodstream infection-related mortality during the first 14 days after placement of the central venous catheter
Definite catheter-related bloodstream infection-related mortality during the first 14 days after placement of the central venous catheter
Time frame: 14 days
Overall incidence of catheter-related bloodstream infection
Overall incidence of catheter-related bloodstream infection (evaluated by definite, probable and proven criteria)
Time frame: From placement of the central venous catheter until the follow-up at a maximum of 56 days
Overall catheter-related bloodstream infection-related severe sepsis
Overall catheter-related bloodstream infection-related severe sepsis (evaluated by definite, probable and proven criteria)
Time frame: From placement of the central venous catheter until the follow-up at a maximum of 56 days
Overall catheter-related bloodstream infection-related mortality
Overall catheter-related bloodstream infection-related mortality(evaluated by definite, probable and proven criteria)
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Universitätsmedizin Berlin - Charité
Berlin, State of Berlin, Germany
Time frame: From placement of the central venous catheter until the follow-up at a maximum of 56 days
Overall mortality
Overall mortality
Time frame: From placement of the central venous catheter until the follow-up at a maximum of 56 days
Time to removal of central venous catheter
Time to removal of central venous catheter
Time frame: From placement of the central venous catheter until the follow-up at a maximum of 56 days
Time to central venous catheter-related blood stream infections
Time to central venous catheter-related blood stream infections
Time frame: From placement of the central venous catheter until the follow-up at a maximum of 56 days
Time to first neutropenic fever
Time to first neutropenic fever
Time frame: From placement of the central venous catheter until the follow-up at a maximum of 56 days
Rate of unplanned changes
Rate of unplanned changes of the catheter securement dressing.
Time frame: From placement of the central venous catheter until the follow-up at a maximum of 56 days
Tolerability/safety
Tolerability/safety is defined as the number of toxicity-related study therapy discontinuations.
Time frame: From placement of the central venous catheter until the follow-up at a maximum of 56 days