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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2021-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

In Vivo Preoperative Skin Preparation Persistence Evaluation

NCT03155178

Bacterial Recovery of Skin Flora Post-product Application

COMPLETED PHASE2

Preoperative Skin Preparation Evaluation

NCT00636480

Topical Antisepsis

COMPLETED PHASE3

Topical Antimicrobial Effectiveness Testing

NCT01366417

Antimicrobial Effectiveness

COMPLETED PHASE4

In Vivo Efficacy Study of Patient Preoperative Preps

NCT02203591

Bacterial Reduction Post-product Application

COMPLETED PHASE3

Effectiveness of an Antimicrobial Agent for Preoperative Skin Preparation

NCT03224299

Preoperative Skin Preparation

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Sepsis Affecting Skin Central Venous Catheter Related Bacteremia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Patients will receive one or the other treatment depending on where and when they are treated and will continue the treatment until the end.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

A (Chloraprep)

Intervention Type DRUG

Chloraprep will be used for the insertion and maintenance of the intravascular device while it is in use (Chlorhexidine 2% + alcohol 70%)

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.

Group Type ACTIVE_COMPARATOR

B (Clorhexidine 2%)

Intervention Type DRUG

Aqueous clorhexidine (2%) will be used for the insertion and maintenance of the intravascular device while it is in use

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

A (Chloraprep)

Chloraprep will be used for the insertion and maintenance of the intravascular device while it is in use (Chlorhexidine 2% + alcohol 70%)

Intervention Type DRUG

B (Clorhexidine 2%)

Aqueous clorhexidine (2%) will be used for the insertion and maintenance of the intravascular device while it is in use

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Chloraprep Clorhexidine 2%

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No