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

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.

Study Overview

• Status: Withdrawn
• Conditions: Sepsis Affecting Skin; Central Venous Catheter Related Bacteremia
• Intervention / Treatment: Drug: A (Chloraprep); Drug: B (Clorhexidine 2%)

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.

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Clorhexidine 2%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Instituto de Investigacion Sanitaria La Fe
• Investigators: Principal Investigator: Paula Ramirez Galleymore, Hospital la Fe

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2019
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): April 1, 2021

Study Registration Dates

• First Submitted: March 14, 2018
• First Submitted That Met QC Criteria: April 4, 2018
• First Posted (Actual): April 5, 2018

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 10, 2020
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Bacteremia
• Other Study ID Numbers: CHLORAPREP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No