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Administrative issues
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A multicentre, open-label clinical trial of two groups comparing cutaneous asepsis with chlorhexidine gluconate at 2% + isopropyl alcohol 70% in relation to the placement of central venous catheters (Study group) with standard asepsis with aqueous chlorhexidine at 2% (Group Control). The incidence of catheter related bacteremia, the incidence of colonization of the skin and the incidence of colonization of the central venous catheter will be evaluated.
A multicentre, open-label clinical trial of two groups comparing cutaneous asepsis with chlorhexidine gluconate at 2% + isopropyl alcohol 70% in relation to the placement of central venous catheters (Study group) with standard asepsis with aqueous chlorhexidine at 2% (Group Control). The incidence of catheter related bacteremia, the incidence of colonization of the skin and the incidence of colonization of the central venous catheter will be evaluated.
The patients will assigned to the treatment group depending on where and when they are treated (site A or site B) and will continue the treatment until the end (continuous design): the patients of Site A will receive the first treatment option and those of Site B will receive the second treatment option during the first 6 months. After this, a rest period of 1 month will be established, during which patients will not be recruited and any of the two cutaneous aseptic methods will be used indiscriminately, in the opinion of the responsible nursing staff. After the resting period, the treatments will be reversed during the following 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A (Chloraprep) | Experimental | 2% chlorhexidine gluconate with 70% isopropyl alcohol with a sterile 3ml single dose applicator. Use for the preparation of the skin before insertion of the central venous catheters and at each dressing change. |
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| B (Clorhexidine 2%) | Active Comparator | 2% aqueous base chlorhexidine (10 ml single dose containers). Use for the preparation of the skin before insertion of the central venous catheters and at each dressing change. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A (Chloraprep) | Drug | Chloraprep will be used for the insertion and maintenance of the intravascular device while it is in use (Chlorhexidine 2% + alcohol 70%) |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of catheter-related bacteremia | Measure the effect of cutaneous asepsis with chlorhexidine gluconate 2% + isopropyl gluconate 70% on the incidence of catheter-related bacteremia in the critical patient with respect to the control group. | Up to 48 hours after discharge from the ICU. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of pericatheter skin colonization | Measure the effect that cutaneous asepsis with chlorhexidine gluconate 2% + isopropyl 70% has on the incidence of pericatheter skin colonization with respect to the control group. Measure with a microbiological culture from the skin area | Through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paula Ramirez Galleymore | Hospital La Fe | Principal Investigator |
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Patients will receive one or the other treatment depending on where and when they are treated and will continue the treatment until the end.
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| B (Clorhexidine 2%) | Drug | Aqueous clorhexidine (2%) will be used for the insertion and maintenance of the intravascular device while it is in use |
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| Incidence of colonization of the central venous catheter |
Measure the effect of cutaneous asepsis with chlorhexidine gluconate 2% + isopropyl 70% on the incidence of colonization of the central venous catheter with respect to the control group. Culture of the tip of the removed catheter. |
| Through study completion, an average of 1 year |