Healthcare Associated Infections Clinical Trial
Official title:
Impact of Daily Bathing With Chlorhexidine in the Critical Patient: Colonization and Environment
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.
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
patient-days will be included. Patients who present burns with more than 20% body surface,
pregnant patients and patients with allergy history to chlorhexidine. Included patients who
develop rash or pruritus after chlorhexidine baths, will be eliminated from the study.
Two weeks previous to the start of the study, MICU personnel will receive theoretical and
practical training, were the bathing technique will be taught. Attendance of personnel will
be recorded and skills will be surveiled during the intervention.
Bathing technique:
Before use, wipe packages will need to be heated in a conventional microwave for 10-12
seconds, under provider instructions. With the use of globes, the entire skin surface will
be covered from the mandibular region to the feet, avoiding contact with mucous membranes
such as anal, nasal or urethral membranes. A circular motion will be implemented during
bathing.
For facial and genital region, wipes or wet dressings will allowed. The facial and genital
region will be the first to clean. Mouthwashes with oral spray solution will be carried out,
trying to properly impregnate cheeks, palate, pharynx and tongue, letting the solution sit
for a minute before removal.
A towel wipe will be used for the neck and shoulders; using a side of the wipe for the
anterior anatomical region and the other side for the posterior region. A wipe will be used
for each limb (4 in total), using one side for the anterior region and the back side for the
posterior region. A wipe will be designated to the buttocks and perianal region, avoiding
the anal region. A wipe will be used for the torso, one for the dorsal region, one for the
feet and one will be reserved for spare. For scalp washing, shampoo foam will be applied in
a circular motion, trying to cover the entire surface of the scalp, excess will be removed
with a dry towels.
Sampling:
Samples will be obtained from the patient and environment. 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; delimiting an area of 3 cm2 and subsequent
application of 1 ml a unionized solution, then proceed to gently scrape the area with a
sterile spatula. This liquid is then retrieved with a pipette and cultured directly on a
blood agar plate. Colonies will then be further selected and properly cultivated according
to their characteristics.
Healthcare personnel samples will also be obtained from pharynx, skin and hands. All these
samples will be collected the day of admission to the MICU, first 72 hours, 10th day and
once a week until discharge of the patient. In the case of healthcare workers, will be
collected at the end of their workday.
Isolate processing:
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. Specimens will be
then frozen to -80ºC.
When processing isolates, conventional phenotypic identification methods will be used. From
primary isolate testing, corresponding biochemical tests will be selected for each species
identification. When phenotypic tests don't reach isolate identification, molecular based
testing and gene amplification will be used.
Antimicrobial susceptibility will be evaluated by the broth microdilution method and
according to protocols M07-A10 and M100-S25 from Clinical and Laboratory Standards Institute
(CLSI) guidelines and processed by an automatized system (SensititreAris 2X).
Pathogen clonal relationship 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. Polymerase chain reaction (PCR) gene
amplification will be obtained to analyze antibiotic resistance patterns for each species.
Pathogen biofilm production:
Biofilm production will be determined by crystal violet staining and a biofilm index will be
obtained by spectrophotometry.
Pathogen susceptibility to chlorhexidine:
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.
Clinical data and follow-up:
Demographics and clinical data will be collected from admission, throughout hospitalization
and discharge. Variables such as previous hospital admission in the previous year, previous
surgeries, history of infection by resistant pathogens, days of hospital stay,
instrumentation (use of foley catheter, mechanical ventilation or central venous catheter)
and clinical evolution evaluated by Acute Physiology and Chronic Health Evaluation
(APACHE-II) and Scale for the Assessment of Positive Symptoms (SAPS).
Positive culture swabs obtained from healthcare workers with resistant pathogens will
proceed with reinforcement of hand hygiene and strengthening in universal protection
(gloves, face mask, etc). If positive Methicillin-resistant Staphylococcus aureus (MRSA)
culture is obtained, intranasal mupirocin treatment will be given for 5 days until a
negative culture is achieved.
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. Surveillance of healthcare associated infections will be
following Center for Disease Control (CDC) guidelines.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research
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