Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hospital Sirio-Libanes | OTHER |
| Hospital Israelita Albert Einstein | OTHER |
| Hospital Moinhos de Vento | OTHER |
| Hospital Alemão Oswaldo Cruz |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorhexidine baths | Experimental | 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. |
|
| Usual baths | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2% chlorhexidine digluconate solution with surface-active agents | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of healthcare-associated infections (HAI) | Composite outcome of the following HAI: Ventilator associated pneumonia (VAP) Central line-associated blood stream infections (CLABSI) Catheter-associated urinary tract infection (CAUTI) | Within each cluster duration (90 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of multi-drug-resistant pathogens | Rates of positive clinical microbiological cultures (colonization and infection) by multi-drug-resistant (MDR) pathogens. | Within each cluster duration (90 days) |
| Ventilator associated pneumonia (VAP) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bruno M Tomazini, M.D | btomazini@hcor.com.br | Principal Investigator |
| Alexandre B Cavalcanti, M.D | HCor Research Institute Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Maternidade São José - UNESC - Fundação Social Rural de Colatina | Colatina | Espírito Santo | Brazil | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41732706 | Derived | 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. |
Not provided
Not provided
Not provided
1 year after publication of primary results
Submission of a statistical analysis plan for the purposed analyses. Compliance with Brazilian. Data privacy law.
Not provided
Not provided
| OTHER |
| Beneficência Portuguesa de São Paulo | OTHER |
The study consists in two intervention (chlorhexidine baths) periods (three months each period) and two control (usual baths) periods (three months each period) for each cluster. The clusters will crossover between intervention and control with one month of washout period between different periods.
Not provided
Not provided
Not provided
|
|
| Usual Baths | Other | 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. |
|
|
Rates of Ventilator associated pneumonia (VAP)
| Within each cluster duration (90 days) |
| Central line-associated blood stream infections (CLABSI) | Rates of Central line-associated blood stream infections (CLABSI) | Within each cluster duration (90 days) |
| Catheter-associated urinary tract infection (CAUTI) | Rates of Catheter-associated urinary tract infection (CAUTI) | Within each cluster duration (90 days) |
| Hospital length of stay | Hospital length of stay | Until hospital discharge, maximum 90 days |
| Intensive Care Unit length of stay | Intensive Care Unit length of stay | Until Intensive Care Unit discharge, maximum 90 days |
| Antibiotic use | Antibiotic use per unit | Within each cluster duration (90 days) |
| In hospital mortality | In hospital mortality | Maximum 90 days after randomization |
| Intensive Care Unit mortality | Intensive Care Unit mortality | Maximum 90 days after randomization |
| Hospital da Bahia |
| Salvador |
| Estado de Bahia |
| Brazil |
| Hospital da Cidade | Salvador | Estado de Bahia | Brazil |
| Hospital Universitário de Brasília | Brasília | Federal District | Brazil |
| Hospital Municipal de Maringá | Maringá | Paraná | Brazil |
| Hospital Regional do Baixo Amazonas Dr. Waldemar Penna | Santarém | Pará | Brazil |
| Hospital das Clínicas da Universidade Federal de Pernambuco | Recife | Pernambuco | Brazil |
| Hospital Geral de Caxias do Sul | Caxias do Sul | Rio Grande do Sul | Brazil |
| Hospital Santa Cruz | Santa Cruz do Sul | Rio Grande do Sul | Brazil |
| Hospital Nereu Ramos | Florianópolis | Santa Catarina | Brazil |
| Instituto Baía Sul de Ensino e Pesquisa Irineu May Brodbeck | Florianópolis | Santa Catarina | Brazil |
| Hospital São Lucas | Aracaju | Sergipe | Brazil |
| Hospital Aviccena | São Paulo | São Paulo | Brazil |
| Hospital Naval Marcílio Dias | Rio de Janeiro | Brazil |
| AC Camargo Câncer Center | São Paulo | Brazil |
| BP-A Beneficiência Portuguesa de São Paulo | São Paulo | Brazil |
| ID | Term |
|---|---|
| D003428 | Cross Infection |
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D007239 | Infections |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000077299 | Healthcare-Associated Pneumonia |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013501 | Surface-Active Agents |
| D012915 | Soaps |
| ID | Term |
|---|---|
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D003902 | Detergents |
| D006795 | Household Products |
| D013676 | Technology, Industry, and Agriculture |
Not provided
Not provided