Daily Chlorexidine Bath for Health Care Associated Infection Prevention

NCT ID: NCT05485051

Last Updated: 2024-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 15730 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-03
• Study Completion Date: 2024-03-31

Brief Summary

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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Chlorhexidine baths

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.

Group Type: EXPERIMENTAL

2% chlorhexidine digluconate solution with surface-active agents

Intervention Type: 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.

Usual baths

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.

Group Type: ACTIVE_COMPARATOR

Usual Baths

Intervention Type: 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.

Interventions

2% chlorhexidine digluconate solution with surface-active agents

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.

Intervention Type: OTHER

Usual 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.

Intervention Type: OTHER

Other Intervention Names

Chlorhexidine baths; Soap and water baths

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• History of chlorhexidine allergy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Sírio-Libanês

UNKNOWN

Sponsor Role: collaborator

Hospital Israelita Albert Einstein

OTHER

Sponsor Role: collaborator

Hospital Moinhos de Vento

OTHER

Sponsor Role: collaborator

Hospital Alemão Oswaldo Cruz

OTHER

Sponsor Role: collaborator

A Beneficência Portuguesa de São Paulo

UNKNOWN

Sponsor Role: collaborator

Hospital do Coracao

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruno M Tomazini, M.D

Role: PRINCIPAL_INVESTIGATOR

btomazini@hcor.com.br

Alexandre B Cavalcanti, M.D

Role: STUDY_DIRECTOR

HCor Research Institute Director

Locations

Hospital Maternidade São José - UNESC - Fundação Social Rural de Colatina

Colatina, Espírito Santo, Brazil

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

Countries

Brazil

Other Identifiers

ip_hcor_cleanit

Identifier Type: -

Identifier Source: org_study_id