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. 2024 Sep 27:36:e20240053en.
doi: 10.62675/2965-2774.20240053-en. eCollection 2024.

Daily Chlorhexidine Bath for Health Care Associated Infection Prevention (CLEAN-IT): protocol for a multicenter cluster randomized crossover open-label trial

[Article in English, Portuguese]
Bruno Martins Tomazini  1   2   3 , Thabata Silva Veiga  1 , Renato Hideo Nakagawa Santos  1 , Viviane Bezerra Campos  1 , Samira Martins Tokunaga  1 , Elton Sousa Santos  1 , Leticia Galvão Barbante  1 , Renato da Costa Maia  1 , Karina Leal Negrelli  1 , Nanci Valeis  1 , Eliana Vieira Santucci  1 , Ligia Nasi Laranjeira  1 , Fernando Azevedo Medrado Jr  1 , Thiago Costa Lisboa  2   4 , Bruno Adler Maccagnan Pinheiro Besen  2   3   5 , Antônio Paulo Nassar Junior  2   6   7 , Viviane Cordeiro Veiga  2   8 , Adriano José Pereira  2   6 , Alexandre Biasi Cavalcanti  1   2
Affiliations

Daily Chlorhexidine Bath for Health Care Associated Infection Prevention (CLEAN-IT): protocol for a multicenter cluster randomized crossover open-label trial

[Article in English, Portuguese]
Bruno Martins Tomazini et al. Crit Care Sci. .

Abstract
in English, Portuguese

Background: Critically ill patients are at increased risk of health care-associated infections due to various devices (central line-associated bloodstream infection, catheter-associated urinary tract infection, and ventilator-associated pneumonia), which pose a significant threat to this population. Among several strategies, daily bathing with chlorhexidine digluconate, a water-soluble antiseptic, has been studied as an intervention to decrease the incidence of health care-associated infections in the intensive care unit; however, its ability to reduce all health care-associated infections due to various devices is unclear. We designed the Daily Chlorhexidine Bath for Health Care Associated Infection Prevention (CLEAN-IT) trial to assess whether daily chlorhexidine digluconate bathing reduces the incidence of health care-associated infections in critically ill patients compared with soap and water bathing.

Methods: The CLEAN-IT trial is a multicenter, open-label, cluster randomized crossover clinical trial. All adult patients admitted to the participating intensive care units will be included in the trial. Each cluster (intensive care unit) will be randomized to perform either initial chlorhexidine digluconate bathing or soap and water bathing with crossover for a period of 3 to 6 months, depending on the time of each center's entrance to the study, with a 1-month washout period between chlorhexidine digluconate bathing and soap and water bathing transitions. The primary outcome is the incidence of health care-associated infections due to devices. The secondary outcomes are the incidence of each specific health care-associated infection, rates of microbiological cultures positive for multidrug-resistant pathogens, antibiotic use, intensive care unit and hospital length of stay, and intensive care unit and hospital mortality.

Conclusion: The CLEAN-IT trial will be used to study feasible and affordable interventions that might reduce the health care-associated infection burden in critically ill patients.

Fundamentos: Pacientes críticos têm maior risco de infecções relacionadas à assistência à saúde devido ao uso de vários dispositivos (infecção da corrente sanguínea associada a cateter central, infecção do trato urinário associada ao cateter e pneumonia associada à ventilação mecânica), o que representa uma ameaça significativa para essa população. Entre as várias estratégias, o banho diário com digluconato de clorexidina, um antisséptico solúvel em água, foi estudado como intervenção para diminuir a incidência de infecções relacionadas à assistência à saúde na unidade de terapia intensiva; no entanto, sua capacidade de reduzir todas as infecções relacionadas à assistência à saúde devido a vários dispositivos não está clara. Desenhamos o estudo Daily Chlorhexidine Bath for Health Care Associated Infection Prevention (CLEAN-IT) para avaliar se o banho diário com digluconato de clorexidina reduz a incidência de infecções relacionadas à assistência à saúde em pacientes críticos em comparação com o banho de água e sabão.

Métodos: O estudo CLEAN-IT é um estudo clínico multicêntrico, aberto, randomizado e em cluster com cruzamentos. Todos os pacientes adultos admitidos nas unidades de terapia intensiva participantes serão incluídos no estudo. Cada grupo (unidade de terapia intensiva) será randomizado para realizar o banho inicial com digluconato de clorexidina ou banho de água e sabão com cruzamento por um período de 3 a 6 meses, dependendo do momento de entrada de cada centro no estudo, com um período de washout de 1 mês entre os banhos com digluconato de clorexidina e as transições para os banhos de água e sabão. O desfecho primário é a incidência de infecções relacionadas à assistência à saúde devido a dispositivos. Os desfechos secundários são a incidência de cada infecção específica relacionada à assistência à saúde, as taxas de coleções microbiológicas positivas para microrganismos multirresistentes, o uso de antibióticos, o tempo de internação na unidade de terapia intensiva e no hospital e a mortalidade na unidade de terapia intensiva e no hospital.

Conclusão: O estudo CLEAN-IT será usado para estudar intervenções viáveis e acessíveis que possam reduzir a incidência de infecções relacionadas à assistência à saúde em pacientes em estado crítico.

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Conflict of interest statement

Conflicts of interest: B. A. M. P. Besen, A. P. Nassar Junior, V. C. Veiga, T. C. Lisboa, and A. B. Cavalcanti are/were part of the editor board of the Journal in the past two years, and they were not involved in any editorial decisions related to this manuscript. The authors declare no other conflicts of interest related to the contents of this manuscript.

Figures

Figure 1
Figure 1. Schematic of possible allocation sequences.
Figura 1
Figura 1. Esquema das possíveis sequências de alocação.
See this image and copyright information in PMC

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