Comparison Trial for Chloraprep Versus Aqueous Chlorhexidine (2%) for the Prevention of Catheter-related Bacteremia
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|ClinicalTrials.gov Identifier: NCT03489512|
Recruitment Status : Withdrawn (Administrative issues)
First Posted : April 5, 2018
Last Update Posted : June 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Sepsis Affecting Skin Central Venous Catheter Related Bacteremia||Drug: A (Chloraprep) Drug: B (Clorhexidine 2%)||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients will receive one or the other treatment depending on where and when they are treated and will continue the treatment until the end.|
|Masking:||None (Open Label)|
|Official Title:||Clinical Phase IV Comparison Trial for 2% Chlorhexidine Skin Asepsis +70% Alcohol Versus Aqueous Chlorhexidine (2%) for the Prevention of Catheter-related Bacteremia in Critical Patients: Preliminary Study|
|Estimated Study Start Date :||October 1, 2019|
|Estimated Primary Completion Date :||October 1, 2020|
|Estimated Study Completion Date :||April 1, 2021|
Experimental: A (Chloraprep)
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.
Drug: A (Chloraprep)
Chloraprep will be used for the insertion and maintenance of the intravascular device while it is in use (Chlorhexidine 2% + alcohol 70%)
Other Name: Chloraprep
Active Comparator: B (Clorhexidine 2%)
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.
Drug: B (Clorhexidine 2%)
Aqueous clorhexidine (2%) will be used for the insertion and maintenance of the intravascular device while it is in use
Other Name: Clorhexidine 2%
- Incidence of catheter-related bacteremia [ Time Frame: Up to 48 hours after discharge from the ICU. ]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.
- Incidence of pericatheter skin colonization [ Time Frame: Through study completion, an average of 1 year ]
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
- Incidence of colonization of the central venous catheter [ Time Frame: Through study completion, an average of 1 year ]
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.
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): NCT03489512
|Principal Investigator:||Paula Ramirez Galleymore||Hospital La Fe|