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

University of Cologne

Status: Completed

Conditions: Bloodstream Infection

Treatments: Device: 3M™ Tegaderm™ CHG IV and 3M™ Tegaderm™ Advanced IV

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01544686

DRKS00003368

Details and patient eligibility

About

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.

Enrollment: 630 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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630 participants in 2 patient groups, including a placebo group

3M™ Tegaderm CHG IV

Active Comparator group

Description:

Patients receive the 3M Tegaderm CHG IV securement dressing after placement of a central venous catheter.

Treatment:

Device: 3M™ Tegaderm™ CHG IV and 3M™ Tegaderm™ Advanced IV

3M™ Tegaderm™ Advanced IV'

Placebo Comparator group

Description:

Patients receive the 3M Tegaderm Advanced IV securement dressing after placement of a central venous catheter.

Treatment:

Device: 3M™ Tegaderm™ CHG IV and 3M™ Tegaderm™ Advanced IV