Clinical Trial: Impact of Daily Bathing With Chlorhexidine in the Critical Patient

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Impact of Daily Bathing With Chlorhexidine in the Critical Patient: Colonization and Environment

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.

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:

This is a prospective, experimental, randomized, open-label, double blind study comparing chlorhexidine versus placebo. The randomization will occur 1:1 and the patients will be divided in two groups. The chlorhexidine group will receive daily baths with chlorhexidine wipes at 2% concentration (CLORHEXI-WIPES ONE-STEP, G70 Antisepsis, León, México), plus oral spray with chlorhexidine chlorhydrate at 0.12%. For scalp washing, a chlorhexidine shampoo at 0.12% concentration will be applied. The placebo group, will receive wipes with the same components as arm #1 plus an oral spray application with the same components except chlorhexidine. For scalp, a standard shampoo will be used. These products will have the same labels and smell as the products in the first arm.

Any patient 18 years or older admitted to the MICU or with less than 48 hours of
Sponsor: Universidad Autonoma de Nuevo Leon

Current Primary Outcome: Pathogen colonization [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Healthcare associated infections [ Time Frame: 1 year ]
  Determine if chlorhexidine baths have an effect on healthcare associated infections. Hospital Epidemiology team's routine surveillance and monitoring will continue throughout the study period. Rate of healthcare associated infections will be compared to before, during and after intervention.
• Pathogen clonal relationship [ Time Frame: 1 year ]
  After specimen identification using conventional methods, pathogen clonal relationship will be obtained. For clonal relationship, pulsed filed gel electrophoresis will be used. Band pattern will be analyzed visually according to Tenover criteria. Data obtained will be analyzed with statistical software. PCR gene amplification will be obtained to analyze antibiotic resistance patterns for each species.
• Pathogen biofilm index [ Time Frame: 1 year ]
  After specimen identification using conventional methods, pathogen biofilm index will also be obtained. Biofilm production will be determined by crystal violet staining and a biofilm index will be obtained by spectrophotometry.
• Pathogen susceptibility to chlorhexidine [ Time Frame: 1 year ]
  For determination of minimum inhibitory concentration (MIC) to chlorhexidine, agar dilution method will be applied according to protocol M07-A9 y M100-S20 in CLSI guidelines. Isolates with MIC values of ≥90, will be denoted with reduced susceptibility to such disinfectant.

Original Secondary Outcome: Same as current

Information By: Universidad Autonoma de Nuevo Leon

Dates:
Date Received: August 7, 2016
Date Started: August 2016
Date Completion: October 2017
Last Updated: August 12, 2016
Last Verified: August 2016