Antimicrobial Catheter Securement Dressings for the Prevention of Cvc-related Bloodstream Infections in Cancer Patients
- Conditions
- Bloodstream Infection
- Interventions
- Device: 3M™ Tegaderm™ CHG IV and 3M™ Tegaderm™ Advanced IV
- Registration Number
- NCT01544686
- Lead Sponsor
- University of Cologne
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 630
- Patients receiving a central venous catheter for chemotherapy of AML or ALL
- Patients receiving a central venous catheter for high-dose chemotherapy with consecutive autologous stem cell transplantation or any other condition with an expected duration of chemotherapy-associated neutropenia of at least 5 days and an expected duration of central venous catheter use of at least 10 days
- Age >= 18 years
- Condition with an expected duration of chemotherapy-associated neutropenia of at less than 5 days and an expected duration of central venous catheter use of less than 10 days
- Use of a central venous catheter with antimicrobial coating other than chlorhexidine and/or silver-sulfadiazine
- Limited venous status, impeding acquisition of peripheral blood cultures in case of febrile neutropenia
- Patients previously enrolled in the study
- Tunneled central venous catheters
- Shaldon catheters
- CVC insertion via the V. femoralis
- Fever (T > 37.8°C) related to a suspected or confirmed bacterial infection at randomization
- Known allergic/hypersensitivity reaction to any compounds of the treatment
- Legal incapacity or limited legal capacity
- Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3M™ Tegaderm CHG IV 3M™ Tegaderm™ CHG IV and 3M™ Tegaderm™ Advanced IV Patients receive the 3M Tegaderm CHG IV securement dressing after placement of a central venous catheter. 3M™ Tegaderm™ Advanced IV' 3M™ Tegaderm™ CHG IV and 3M™ Tegaderm™ Advanced IV Patients receive the 3M Tegaderm Advanced IV securement dressing after placement of a central venous catheter.
- Primary Outcome Measures
Name Time Method Incidence of definite catheter-related bloodstream infection during the first 14 days after placement of the central venous catheter 14 days Incidence of definite catheter-related bloodstream infection during the first 14 days after placement of the central venous catheter
- Secondary Outcome Measures
Name Time Method Incidence of definite catheter related bloodstream infection-related severe sepsis during the first 14 days after placement of the central venous catheter 14 days Incidence of definite catheter related bloodstream infection-related severe sepsis 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 14 days Definite catheter-related bloodstream infection-related mortality during the first 14 days after placement of the central venous catheter
Overall incidence of catheter-related bloodstream infection From placement of the central venous catheter until the follow-up at a maximum of 56 days Overall incidence of catheter-related bloodstream infection (evaluated by definite, probable and proven criteria)
Overall catheter-related bloodstream infection-related severe sepsis 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 (evaluated by definite, probable and proven criteria)
Overall mortality From placement of the central venous catheter until the follow-up at a maximum of 56 days Overall mortality
Time to first neutropenic fever From placement of the central venous catheter until the follow-up at a maximum of 56 days Time to first neutropenic fever
Tolerability/safety From placement of the central venous catheter until the follow-up at a maximum of 56 days Tolerability/safety is defined as the number of toxicity-related study therapy discontinuations.
Rate of unplanned changes From placement of the central venous catheter until the follow-up at a maximum of 56 days Rate of unplanned changes of the catheter securement dressing.
Overall catheter-related bloodstream infection-related mortality From placement of the central venous catheter until the follow-up at a maximum of 56 days Overall catheter-related bloodstream infection-related mortality(evaluated by definite, probable and proven criteria)
Time to removal of central venous catheter 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 central venous catheter-related blood stream infections 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
Trial Locations
- Locations (5)
Universitätsklinikum Aachen
🇩🇪Aachen, NRW, Germany
University Hospital Cologne
🇩🇪Cologne, NRW, Germany
Universitätsmedizin Berlin - Charité
🇩🇪Berlin, Germany
Klinikum Schwabing
🇩🇪Munich, Bavaria, Germany
Klinikum Neuperlach
🇩🇪Munich, Bavaria, Germany