NCT03489512

Comparison Trial for Chloraprep Versus Aqueous Chlorhexidine (2%) for the Prevention of Catheter-related Bacteremia

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Instituto de Investigacion Sanitaria La Fe · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Sepsis Affecting Skin
• Central Venous Catheter Related Bacteremia

Interventions

Type	Name	Description
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%)
DRUG	B (Clorhexidine 2%)	Aqueous clorhexidine (2%) will be used for the insertion and maintenance of the intravascular device while it is in use

Timeline

• Start date: 2019-10-01
• Primary completion: 2020-10-01
• Completion: 2021-04-01
• First posted: 2018-04-05
• Last updated: 2020-06-11