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

Phase 4

Withdrawn

• Conditions: Sepsis Affecting Skin; Central Venous Catheter Related Bacteremia
• Interventions: Drug: A (Chloraprep); Drug: B (Clorhexidine 2%)

• Registration Number: NCT03489512
• Lead Sponsor: Instituto de Investigacion Sanitaria La Fe

Brief 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.

Study Timeline

• Study First Submitted: 2018-03-14
• Study First Submitted QC: 2018-04-04
• Study First Posted: 2018-04-05
• Status Verified: 2019-08
• Study Start: 2019-10-01
• Last Update Submitted: 2020-06-10
• Last Update Posted: 2020-06-11
• Primary Completion: 2020-10-01
• Study Completion: 2021-04-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A (Chloraprep)	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.
B (Clorhexidine 2%)	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.

Primary Outcome Measures

Name	Time	Method
Incidence of catheter-related bacteremia	Up to 48 hours after discharge from the ICU.	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of pericatheter skin colonization	Through study completion, an average of 1 year	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
Incidence of colonization of the central venous catheter	Through study completion, an average of 1 year	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.