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

Instituto de Investigacion Sanitaria La Fe

Status and phase: Withdrawn; Phase 4

Conditions: Central Venous Catheter Related Bacteremia; Sepsis Affecting Skin

Treatments: Drug: A (Chloraprep); Drug: B (Clorhexidine 2%)

Study type: Interventional

Funder types: Other

Identifiers

NCT03489512

CHLORAPREP

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients admitted to the ICU.
• Patients with age greater than or equal to 18 years.
• Patients who require at least one central venous catheters during 48h or more.
• Obtaining informed consent.

Exclusion criteria

• Intolerance or known allergy to chlorhexidine, isopropyl alcohol or orange yellow S (E110).
• High probability of death within 48 hours after admission.
• Use of coated catheter.
• Previously included in the study.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

A (Chloraprep)

Experimental group

Description:

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.

Treatment:

Drug: A (Chloraprep)

B (Clorhexidine 2%)

Active Comparator group

Description:

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.

Treatment:

Drug: B (Clorhexidine 2%)