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Impact of Daily Bathing With Chlorhexidine in the Critical Patient

NCT02870062 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-08-17

No results posted yet for this study

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.

Conditions

  • Healthcare Associated Infections

Interventions

OTHER

Daily baths with chlorhexidine wipes, oral spray and standard shampoo

Description already mentioned in arm/group descriptions.

OTHER

Daily baths with placebo wipes, oral spray and shampoo

Description already mentioned in arm/group descriptions.

Sponsors & Collaborators

  • Universidad Autonoma de Nuevo Leon

    lead OTHER

Principal Investigators

  • Michel F Martinez-Resendez, M.D. · Associate Professor of Infectious Diseases

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-09-30
Completion
2017-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02870062 on ClinicalTrials.gov