Daily Chlorexidine Bath for Health Care Associated Infection Prevention

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.

• 2% chlorhexidine digluconate solution with surface-active agents (Other), also known as Chlorhexidine baths: Bathing will be performed at least daily using 2% chlorhexidine digluconate solution with surface-active agents on all applicable bathing surfaces, which consists of the entire body surface of the patient except eyes, inner ear, oral mucosa, and areas of loss of skin continuity (such as burnt areas, pressure injuries, etc.); These areas will be bathed according to each center current practice.
• Usual Baths (Other), also known as Soap and water baths: Bathing will be performed at least daily using soap and water (performed according to the current practice in each center) on all applicable bathing surfaces, which consists of the entire body surface of the patient except eyes, inner ear, oral mucosa, and areas of loss of skin continuity (such as burnt areas, pressure injuries, etc.); These areas will be bathed according to each center current practice.

Primary outcomes

• Composite of healthcare-associated infections (HAI) [Within each cluster duration (90 days)]: Composite outcome of the following HAI: Ventilator associated pneumonia (VAP) Central line-associated blood stream infections (CLABSI) Catheter-associated urinary tract infection (CAUTI)

Secondary outcomes

• Rates of multi-drug-resistant pathogens [Within each cluster duration (90 days)]: Rates of positive clinical microbiological cultures (colonization and infection) by multi-drug-resistant (MDR) pathogens.
• Ventilator associated pneumonia (VAP) [Within each cluster duration (90 days)]: Rates of Ventilator associated pneumonia (VAP)
• Central line-associated blood stream infections (CLABSI) [Within each cluster duration (90 days)]: Rates of Central line-associated blood stream infections (CLABSI)
• Catheter-associated urinary tract infection (CAUTI) [Within each cluster duration (90 days)]: Rates of Catheter-associated urinary tract infection (CAUTI)
• Hospital length of stay [Until hospital discharge, maximum 90 days]: Hospital length of stay
• Intensive Care Unit length of stay [Until Intensive Care Unit discharge, maximum 90 days]: Intensive Care Unit length of stay
• Antibiotic use [Within each cluster duration (90 days)]: Antibiotic use per unit
• In hospital mortality [Maximum 90 days after randomization]: In hospital mortality
• Intensive Care Unit mortality [Maximum 90 days after randomization]: Intensive Care Unit mortality

Sex: All, ages: 18 Years to any

Inclusion Criteria:

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

Exclusion Criteria:

* History of chlorhexidine allergy

• Results publication: Tomazini BM, Besen BAMP, Gales AC, Bianchini L, Lisboa T, Maia IS, Veiga TS, Santos RHN, Santos ES, Tokunaga SM, Barbante LG, Campos VB, Kojima FCS, Miranda TA, Ramos NC, Prestes RM, Lima VP, Freitas P, Vidal CFL, Santiago RCB, Dracoulakis MDA, Romano M, Melo RMV, Pereira FC, Rozetti CMT, Souza RM, Lacerda FH, Berti IR, Irineu V, Figueiredo RC, Magdalena MS, Dantas VC, Arns B, Marssola G, Veiga VC, Pereira AJ, Nassar AP Jr, Cavalcanti AB. Daily Chlorhexidine Bathing for the Prevention of Nosocomial Infections in Critically Ill Patients (CLEAN-IT): a multicentre, cluster-randomised, crossover trial. Lancet Reg Health Am. 2026 Feb 12;56:101400. doi: 10.1016/j.lana.2026.101400. eCollection 2026 Apr. PMID 41732706

• Bruno M Tomazini, M.D, Principal investigator, btomazini@hcor.com.br
• Alexandre B Cavalcanti, M.D, Study director, HCor Research Institute Director