A Phase 4 interventional study of A (Chloraprep) and B (Clorhexidine 2%) in Sepsis Affecting Skin and Central Venous Catheter Related Bacteremia, sponsored by Instituto de Investigacion Sanitaria La Fe. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-11.
Sponsored by Instituto de Investigacion Sanitaria La Fe · Phase 4, Interventional, and Prevention
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.
297 studies on the registry are indexed under Bacteremia; 51 are open to participants now.
Browse Bacteremia studies →Instituto de Investigacion Sanitaria La Fe is the lead sponsor of 59 studies on the registry; 14 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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%)
Chloraprep will be used for the insertion and maintenance of the intravascular device while it is in use (Chlorhexidine 2% + alcohol 70%)
Also known as: Chloraprep
Aqueous clorhexidine (2%) will be used for the insertion and maintenance of the intravascular device while it is in use
Also known as: Clorhexidine 2%
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.
Time frame: Up to 48 hours after discharge from the ICU.
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
Time frame: Through study completion, an average of 1 year
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.
Time frame: Through study completion, an average of 1 year
No study locations are listed for this record.
Start is estimated for Oct 2019; primary completion for Oct 2020, 12 months later.
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This study is withdrawn, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Chlorhexidine/Ethyl Alcohol Mouthwash
Instituto de Investigacion Sanitaria La Fe