Daily Chlorexidine Bath for Health Care Associated Infection Prevention (CLEAN-IT)

Hospital do Coracao

Status and phase: Completed; Phase 3

Conditions: Catheter-Associated Urinary Tract Infection; Ventilator Associated Pneumonia; Central Line-associated Bloodstream Infection (CLABSI); Health Care Associated Infection

Treatments: Other: Usual Baths; Other: 2% chlorhexidine digluconate solution with surface-active agents

Study type: Interventional

Funder types: Other

Identifiers

NCT05485051

ip_hcor_cleanit

Details and patient eligibility

About

Cluster randomized controlled trial comparing two bathing strategies in critically ill patients. The intervention group will receive daily bathing with chlorhexidine. The control group will receive usual care.

Full description

Healthcare-associated infections (HAI) are common complications in critically ill patients and are associated with increased costs, higher length of stay, and higher morbimortality. Data shows that daily chlorhexidine baths might be associated with lower HAI rates in a broad population of critically ill patients. The purpose of this trial is to evaluate the effect of daily bathing with chlorhexidine compared to usual baths (soap and water) on HAI in critically ill patients.

Enrollment: 15,730 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients ≥ 18 years/old admitted to the participants's ICUs

Exclusion criteria

• History of chlorhexidine allergy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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15,730 participants in 2 patient groups

Chlorhexidine baths

Experimental group

Description:

All patients in the cluster randomized to the intervention arm will receive baths using a 2% chlorhexidine digluconate solution with surface-active agents during the intervention period. All other infection control and cleaning procedures will be performed according to the current practice in each center.

Treatment:

Other: 2% chlorhexidine digluconate solution with surface-active agents

Usual baths

Active Comparator group

Description:

All patients in the cluster randomized to the intervention arm will receive baths using soap and water according to the current practice in each center during the intervention period. All other infection control and cleaning procedures will be performed according to the current practice in each center.

Treatment:

Other: Usual Baths