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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01544686
First Posted: March 6, 2012
Last Update Posted: December 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
3M
Information provided by (Responsible Party):
Maria J.G.T. Vehreschild, University of Cologne
  Purpose
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.

Condition Intervention
Bloodstream Infection Device: 3M™ Tegaderm™ CHG IV and 3M™ Tegaderm™ Advanced IV

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Chlorhexidine Containing Iv-securement Dressings for the Prevention of Central Venous Catheter-related Blood Stream Infections in Neutropenic Patients: a Randomized Trial

Resource links provided by NLM:


Further study details as provided by Maria J.G.T. Vehreschild, University of Cologne:

Primary Outcome Measures:
  • 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 during the first 14 days after placement of the central venous catheter


Secondary Outcome Measures:
  • 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 ]
    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 [ Time Frame: 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 [ Time Frame: 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 [ 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 (evaluated by definite, probable and proven criteria)

  • Overall catheter-related bloodstream infection-related mortality [ 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(evaluated by definite, probable and proven criteria)

  • Overall mortality [ Time Frame: From placement of the central venous catheter until the follow-up at a maximum of 56 days ]
    Overall mortality

  • 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 removal of central venous catheter

  • 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 central venous catheter-related blood stream infections

  • Time to first neutropenic fever [ Time Frame: From placement of the central venous catheter until the follow-up at a maximum of 56 days ]
    Time to first neutropenic fever

  • Rate of unplanned changes [ Time Frame: 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.

  • Tolerability/safety [ Time Frame: 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.


Enrollment: 630
Study Start Date: February 2012
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 3M™ Tegaderm CHG IV
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
Patients receive the 3M™ Tegaderm CHG IV securement dressing or the 3M Tegaderm Advanced IV securement dressing after placement of a central venous catheter.
Placebo Comparator: 3M™ Tegaderm™ Advanced IV'
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
Patients receive the 3M™ Tegaderm CHG IV securement dressing or the 3M Tegaderm Advanced IV securement dressing after placement of a central venous catheter.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01544686


Locations
Germany
Klinikum Schwabing
Munich, Bavaria, Germany, 80804
Klinikum Neuperlach
Munich, Bavaria, Germany, 81737
Universitätsklinikum Aachen
Aachen, NRW, Germany, 52074
University Hospital Cologne
Cologne, NRW, Germany, 50937
Universitätsmedizin Berlin - Charité
Berlin, Germany, 10117
Sponsors and Collaborators
University of Cologne
3M
Investigators
Principal Investigator: Maria JG Vehreschild, Dr. med. University Hospital of Cologne
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maria J.G.T. Vehreschild, Principal Investigator, University of Cologne
ClinicalTrials.gov Identifier: NCT01544686     History of Changes
Other Study ID Numbers: DRKS00003368
First Submitted: February 22, 2012
First Posted: March 6, 2012
Last Update Posted: December 9, 2015
Last Verified: December 2015

Keywords provided by Maria J.G.T. Vehreschild, University of Cologne:
neutropenia
cancer
fever
central venous catheter
infection

Additional relevant MeSH terms:
Infection
Communicable Diseases