Impact of Daily Bathing With Chlorhexidine in the Critical Patient: Colonization and Environment
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 40
- Primary Endpoint
- Pathogen colonization
Study Overview
Brief Summary
The search for preventive measure with daily bathing with chlorhexidine in the critical care patient will result in a reduction in patient colonization with multidrug resistant pathogens. Thus, preventing healthcare associated infections. The aim of this study was to determine the impact of daily bathing with chlorhexidine in patient colonization, environment and healthcare workers in the medical intensive care unit (MICU).
The study will be conducted at the University Hospital "Dr. José Eleuterio González", a 450-bed teaching hospital in Monterrey, northeast Mexico.
This is a prospective, experimental, randomized, open-label, double blind study comparing chlorhexidine versus placebo. Any patient 18 years or older admitted to the MICU or with less than 48 hours of patient-days will be included. Patients who present burns with more than 20% body surface, pregnant patients and patients with allergy history to chlorhexidine.
Samples will be obtained from the patient, patient environment and healthcare personnel.
Sampling of the environment (bed rail, mechanical ventilator, table adjacent to the bed, etc.) and patient's anogenital and pharyngeal region will be collected with "swabbing" technique using cotton swabs and cultured according to Public Health England.
Patient skin sampling will be obtained from anorectal region, pharynx, axillary and inguinal fold collected with Williamson-Kligman technique. Colonies will then be further selected and properly cultivated according to their characteristics. Antibiotic susceptibility, clonal relationship, biofilm index and antibiotic susceptibility to chlorhexidine will be determined.
Demographics and clinical data will be collected from admission, throughout hospitalization and discharge.
Detailed Description
Introduction:
The search for preventive measure with daily bathing with chlorhexidine in the critical care patient will result in a reduction in patient colonization with multidrug resistant pathogens. Thus, preventing healthcare associated infections. The aim of this study was to determine the impact of daily bathing with chlorhexidine in patient colonization, environment and healthcare workers in the medical intensive care unit (MICU).
Setting:
The study will be conducted at the University Hospital "Dr. José Eleuterio González", a 450-bed teaching hospital in Monterrey, northeast Mexico. The hospital has an average of 22 to 23 thousand yearly discharges with a 20 bed and 15 bed ICU for adults and pediatric/neonatal patients, respectively.
Design and methods:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Any patient admitted to the medical intensive care unit
- •Any patient with less than 48 hours in the medical intensive care unit
- •Patient's age 18 years or older
Exclusion Criteria
- •Patients with burns greater than 20% body surface
- •Pregnancy
- •Patients with recorded allergy history to chlorhexidine
- •Elimination Criteria:
- •Patient refuses participation in the study
- •Patient develops severe reaction to chlorhexidine, defined as the sudden appearance of rash and/or pruritus.
Outcomes
Primary Outcomes
Pathogen colonization
Time Frame: 1 year
Determine the impact of daily bathing with chlorhexidine in patient colonization, study setting and healthcare workers in the MICU. Patient skin sample and environment swabbing will be collected in day 0 of admission to MICU, day 10 and once a week till discharge. Healthcare worker samples will be collected at the end of every workday. Samples will be cultured using conventional methods: from prime media, colonies will be taken separately and will be placed in a Brucella broth with 15% glycerol and then frozen to -80ºC. When processing isolates, conventional phenotypic identification methods will be used. Antimicrobial susceptibility will be evaluated by the broth microdilution method according to CLSI guidelines and processed by an automatized system (SensititreAris 2X).
Secondary Outcomes
- Pathogen clonal relationship(1 year)
- Pathogen biofilm index(1 year)
- Pathogen susceptibility to chlorhexidine(1 year)
- Healthcare associated infections(1 year)
Investigators
Michel Fernando Martinez-Resendez
M.D., Ph.D.
Universidad Autonoma de Nuevo Leon