Antimicrobial Catheter Securement Dressings for the Prevention of Cvc-related Bloodstream Infections in Cancer Patients
NCT ID: NCT01544686
Last Updated: 2015-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
630 participants
INTERVENTIONAL
2012-02-29
2015-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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3M™ Tegaderm CHG IV
Patients receive the 3M Tegaderm CHG IV securement dressing after placement of a central venous catheter.
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.
3M™ Tegaderm™ Advanced IV'
Patients receive the 3M Tegaderm Advanced IV securement dressing after placement of a central venous catheter.
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.
Interventions
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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 Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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3M
INDUSTRY
University of Cologne
OTHER
Responsible Party
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Maria J.G.T. Vehreschild
Principal Investigator
Principal Investigators
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Maria JG Vehreschild, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Cologne
Locations
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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
Universitätsmedizin Berlin - Charité
Berlin, State of Berlin, Germany
Countries
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References
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Schalk E, Teschner D, Hentrich M, Boll B, Panse J, Schmidt-Hieber M, Vehreschild MJGT, Biehl LM. Central venous catheter-related bloodstream infections in patients with hematological malignancies: Comparison of data from a clinical registry and a randomized controlled trial. Infect Control Hosp Epidemiol. 2020 Feb;41(2):254-256. doi: 10.1017/ice.2019.335. No abstract available.
Schalk E, Biehl LM, Farber J, Schluter D, Vehreschild MJGT, Fischer T. Determination of a Cutoff Time Point for Prophylactic Exchange of Central Venous Catheters for Prevention of Central Venous Catheter-Related Bloodstream Infections in Patients with Hematological Malignancies. Infect Control Hosp Epidemiol. 2017 Jul;38(7):888-889. doi: 10.1017/ice.2017.92. Epub 2017 May 18. No abstract available.
Biehl LM, Huth A, Panse J, Kramer C, Hentrich M, Engelhardt M, Schafer-Eckart K, Kofla G, Kiehl M, Wendtner CM, Karthaus M, Ullmann AJ, Hellmich M, Christ H, Vehreschild MJ. A randomized trial on chlorhexidine dressings for the prevention of catheter-related bloodstream infections in neutropenic patients. Ann Oncol. 2016 Oct;27(10):1916-22. doi: 10.1093/annonc/mdw275. Epub 2016 Jul 25.
Other Identifiers
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DRKS00003368
Identifier Type: -
Identifier Source: org_study_id