Antimicrobial Catheter Securement Dressings for the Prevention of Cvc-related Bloodstream Infections in Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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Chlorhexidine Containing Iv-securement Dressings for the Prevention of Central Venous Catheter-related Blood Stream Infections in Neutropenic Patients: a Randomized Trial

Conditions
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Bloodstream Infection

Intervention / Treatment
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* Device: 3M™ Tegaderm™ CHG IV and 3M™ Tegaderm™ Advanced IV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 3M™ Tegaderm CHG IV<br>Patients receive the 3M Tegaderm CHG IV securement dressing after placement of a central venous catheter. | Device: 3M™ Tegaderm™ CHG IV and 3M™ Tegaderm™ Advanced IV<br>* Patients receive the 3M™ Tegaderm CHG IV securement dressing or the 3M Tegaderm Advanced IV securement dressing after placement of a central venous catheter.<br>|
| Placebo Comparator: 3M™ Tegaderm™ Advanced IV'<br>Patients receive the 3M Tegaderm Advanced IV securement dressing after placement of a central venous catheter. | Device: 3M™ Tegaderm™ CHG IV and 3M™ Tegaderm™ Advanced IV<br>* Patients receive the 3M™ Tegaderm CHG IV securement dressing or the 3M Tegaderm Advanced IV securement dressing after placement of a central venous catheter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 14 days | 
| Overall incidence of catheter-related bloodstream infection | Overall incidence of catheter-related bloodstream infection (evaluated by definite, probable and proven criteria) | 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) | 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) | From placement of the central venous catheter until the follow-up at a maximum of 56 days | 
| Overall mortality | Overall mortality | 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 | 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 | 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 | 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. | 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. | From placement of the central venous catheter until the follow-up at a maximum of 56 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neutropenia, cancer, fever, central venous catheter, infection