4% Chlorhexidine Gluconate Daily Bathing for Prevention of Hospital-acquired Infections in Intensive Care Settings (Duclorexint)

University Of Perugia

Status and phase: Completed; Phase 4

Conditions: Hospital Infection

Treatments: Other: standard soap; Drug: 4% chlorhexidine gluconate soap-like solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03639363

Duclorexint

Details and patient eligibility

About

The study will assess the utility of 4% chlorhexidine gluconate (CHG) daily bathing to reduce hospital acquired infections in patients admitted to intensive care units. One group will be daily bathed with 4% CHG and the other group with standard soap.

Enrollment: 449 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• admission to the intensive care unit (ICU) or to the post-operative cardiosurgical ICU (PC-ICU)
• ICU/PC-ICU stay for at least 1 night

Exclusion criteria

• known allergy to chlorhexidine
• burns, toxic epidermal necrolysis or Stevens-Johnson syndrome as admission diagnosis
• pregnancy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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449 participants in 2 patient groups

Intervention Arm

Experimental group

Description:

daily bathing with 4% chlorhexidine gluconate soap-like solution followed by water rinsing

Treatment:

Drug: 4% chlorhexidine gluconate soap-like solution

Control Arm

Active Comparator group

Description:

daily bathing with standard soap

Treatment:

Other: standard soap