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

NCT ID: NCT03639363

Last Updated: 2018-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 449 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-10
• Study Completion Date: 2016-05-02

Brief Summary

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.

Conditions

Hospital Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Intervention Arm

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

Group Type: EXPERIMENTAL

4% chlorhexidine gluconate soap-like solution

Intervention Type: DRUG

1. humidify the whole body surface with the exception of the face using water-impregnated washcloths

2. use 4% CHG-impregnated washcloths to bath the whole body surface with the exception of the face; use at least 30 ml of 4% CHG

3. wait for at least 30 seconds

4. rinse using water-impregnated washcloths

Control Arm

daily bathing with standard soap

Group Type: ACTIVE_COMPARATOR

standard soap

Intervention Type: OTHER

1. humidify the whole body surface with the exception of the face using water-impregnated washcloths

2. use standard soap-impregnated washcloths to bath the whole body surface with the exception of the face

3. wait for at least 30 seconds

4. rinse using water-impregnated washcloths

Interventions

4% chlorhexidine gluconate soap-like solution

1. humidify the whole body surface with the exception of the face using water-impregnated washcloths

2. use 4% CHG-impregnated washcloths to bath the whole body surface with the exception of the face; use at least 30 ml of 4% CHG

3. wait for at least 30 seconds

4. rinse using water-impregnated washcloths

Intervention Type: DRUG

standard soap

1. humidify the whole body surface with the exception of the face using water-impregnated washcloths

2. use standard soap-impregnated washcloths to bath the whole body surface with the exception of the face

3. wait for at least 30 seconds

4. rinse using water-impregnated washcloths

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Toscana Gabriele Monasterio

OTHER

Sponsor Role: collaborator

University Of Perugia

OTHER

Sponsor Role: lead

Responsible Party

Carlo Pallotto

Medical Doctor, Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

franco baldelli, Professor

Role: STUDY_CHAIR

Infectious Diseases Clinical, University Hospital of Perugia, Perugia, Italy

References

Pallotto C, Fiorio M, De Angelis V, Ripoli A, Franciosini E, Quondam Girolamo L, Volpi F, Iorio P, Francisci D, Tascini C, Baldelli F. Daily bathing with 4% chlorhexidine gluconate in intensive care settings: a randomized controlled trial. Clin Microbiol Infect. 2019 Jun;25(6):705-710. doi: 10.1016/j.cmi.2018.09.012. Epub 2018 Sep 26.

Reference Type: DERIVED

PMID: 30267930 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Duclorexint

Identifier Type: -

Identifier Source: org_study_id