Clinical trial · Interventional
Antimicrobial Catheter Securement Dressings for the Prevention of Cvc-related Bloodstream Infections in Cancer Patients
Chlorhexidine Containing Iv-securement Dressings for the Prevention of Central Venous Catheter-related Blood Stream Infections in Neutropenic Patients: a Randomized Trial
NCT01544686CI-TRIAL-00020126COATcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bloodstream Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3M™ Tegaderm™ CHG IV and 3M™ Tegaderm™ Advanced IV | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 3M™ Tegaderm CHG IV
- description
- Patients receive the 3M Tegaderm CHG IV securement dressing after placement of a central venous catheter.
- interventionNames
- Device: 3M™ Tegaderm™ CHG IV and 3M™ Tegaderm™ Advanced IV
- type
- PLACEBO_COMPARATOR
- label
- 3M™ Tegaderm™ Advanced IV'
- description
- Patients receive the 3M Tegaderm Advanced IV securement dressing after placement of a central venous catheter.
- interventionNames
- Device: 3M™ Tegaderm™ CHG IV and 3M™ Tegaderm™ Advanced IV
Primary outcomes (1)
- measure
- Incidence of definite catheter-related bloodstream infection during the first 14 days after placement of the central venous catheter
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDSchalk 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. PMID 31818338
- DERIVEDSchalk 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. PMID 28514979
- DERIVEDBiehl 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. PMID 27456299