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Daily Chlorhexidine Bathing for the Prevention of Nosocomial Infections in Critically Ill Patients (CLEAN-IT): a multicentre, cluster-randomised, crossover trial

Tomazini BM, Besen BAMP, Gales AC, Bianchini L, Lisboa T, Maia IS, Veiga TS, Santos RHN et al.

Lancet regional health. Americas, 2026

15,935 participants · 2 citations

Abstract

Background: Critically ill patients are at risk of nosocomial infections, acquisition of multidrug-resistant pathogens, and substantial antimicrobial consumption. We assessed whether bathing with chlorhexidine reduces these outcomes compared to standard practices.

Methods: We conducted an open-label, cluster-randomised crossover trial in 22 Brazilian intensive care units comparing daily chlorhexidine bathing versus soap and water bathing (control). Centres were randomised to 3- or 6-months chlorhexidine or control periods, separated by a 1-month washout. Primary outcome was nosocomial infection rate (central line-associated bloodstream infections, catheter-associated urinary tract infections, and ventilator-associated pneumonia) during ICU stay. Secondary outcomes included specific nosocomial infections incidence, multi-drug resistant cultures, antibiotic use, length of stay, and mortality. This completed trial is registered at ClinicalTrials.gov, NCT05485051.

Findings: From August 1st, 2022 to December 31, 2023, we included 15,935 patients (8247 chlorhexidine and 7688 control group). Mean age was 64·4 years (SD 17·3) in the chlorhexidine group [4315 (52·3%) male] and 64·2 years (SD 17·4) in the control group [4035 (52·5%) male]. A total of 201 nosocomial infections occurred in the chlorhexidine group, compared to 165 in the control group. There was no statistically significant difference in the overall nosocomial infections rate between groups [3·99 per 1000 patient-days in…

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 15,935 participants or records.

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