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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3M™ Tegaderm CHG IV | Active Comparator | Patients receive the 3M Tegaderm CHG IV securement dressing after placement of a central venous catheter. |
|
| 3M™ Tegaderm™ Advanced IV' | Placebo Comparator | Patients receive the 3M Tegaderm Advanced IV securement dressing after placement of a central venous catheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3M™ Tegaderm™ CHG IV and 3M™ Tegaderm™ Advanced IV | Device | Patients receive the 3M™ Tegaderm CHG IV securement dressing or the 3M Tegaderm Advanced IV securement dressing after placement of a central venous catheter. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria JG Vehreschild, Dr. med. | University Hospital of Cologne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Schwabing | Munich | Bavaria | 80804 | Germany | ||
| Klinikum Neuperlach |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31818338 | Derived | 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. | |
| 28514979 |
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| 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 |
| Munich |
| Bavaria |
| 81737 |
| Germany |
| Universitätsklinikum Aachen | Aachen | North Rhine-Westphalia | 52074 | Germany |
| University Hospital Cologne | Cologne | North Rhine-Westphalia | 50937 | Germany |
| Universitätsmedizin Berlin - Charité | Berlin | State of Berlin | 10117 | Germany |
| Derived |
| 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. |
| 27456299 | Derived | 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. |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D009503 | Neutropenia |
| D009369 | Neoplasms |
| D005334 | Fever |
| D007239 | Infections |
| ID | Term |
|---|---|
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
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