Impact of Daily Bathing With Chlorhexidine in the Critical Patient

NCT02870062 | Unknown Phase 1

• 1 other identifier: IF16-003
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthcare Associated Infections

Keywords

Chlorhexidine baths; Critical patient; Healthcare associated infections; Critical care environment; Patient colonization

Outcome Measures

Primary Outcomes (1)

• Pathogen colonization

  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).

  1 year

Secondary Outcomes (4)

• Healthcare associated infections

  1 year

• Pathogen clonal relationship

  1 year

• Pathogen biofilm index

  1 year

• Pathogen susceptibility to chlorhexidine

  1 year

Study Arms (2)

Chlorhexidine

EXPERIMENTAL

Intervention: daily baths with chlorhexidine wipes, oral spray and shampoo. This arm will receive daily bathing with chlorhexidine wipes at 2% (CLORHEXI-WIPES ONE-STEP, G70 Antisepsis, León, México) plus an oral spray application of chlorhexidine chlorhydrate at 0.12%. For scalp washing, a chlorhexidine shampoo at 0.12% concentration will be applied.

Other: Daily baths with chlorhexidine wipes, oral spray and standard shampoo

Placebo

PLACEBO COMPARATOR

Intervention: daily baths with placebo wipes, oral spray and standard shampoo. This arm 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 arm #1.

Other: Daily baths with placebo wipes, oral spray and shampoo

Interventions

Daily baths with chlorhexidine wipes, oral spray and standard shampoo OTHER

Description already mentioned in arm/group descriptions.

Also known as: CLORHEXI-WIPES ONE-STEP, G70 Antisepsis

Chlorhexidine

Daily baths with placebo wipes, oral spray and shampoo OTHER

Description already mentioned in arm/group descriptions.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Autonoma de Nuevo Leon: lead

Related Publications (3)

• Williamson P, Kligman AM. A new method for the quantitative investigation of cutaneous bacteria. J Invest Dermatol. 1965 Dec;45(6):498-503. doi: 10.1038/jid.1965.164. No abstract available.

  PMID: 5321315 BACKGROUND

• Tenover FC, Arbeit RD, Goering RV, Mickelsen PA, Murray BE, Persing DH, Swaminathan B. Interpreting chromosomal DNA restriction patterns produced by pulsed-field gel electrophoresis: criteria for bacterial strain typing. J Clin Microbiol. 1995 Sep;33(9):2233-9. doi: 10.1128/jcm.33.9.2233-2239.1995. No abstract available.

  PMID: 7494007 BACKGROUND

• Christensen GD, Simpson WA, Younger JJ, Baddour LM, Barrett FF, Melton DM, Beachey EH. Adherence of coagulase-negative staphylococci to plastic tissue culture plates: a quantitative model for the adherence of staphylococci to medical devices. J Clin Microbiol. 1985 Dec;22(6):996-1006. doi: 10.1128/jcm.22.6.996-1006.1985.

  PMID: 3905855 BACKGROUND

MeSH Terms

Conditions

Cross Infection

Interventions

Oral Sprays

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Michel F Martinez-Resendez, M.D.

  Associate Professor of Infectious Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: August 7, 2016
• First Posted: August 17, 2016
• Study Start: August 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: October 1, 2017
• Last Updated: August 17, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share