MedPath

Evaluation of Two Hand Hygiene Products in ICUs

Phase 4
Completed
Conditions
Hand Hygiene Effectiveness
Interventions
Drug: hand antiseptic with CHG and alcohol
Registration Number
NCT02258412
Lead Sponsor
Solventum US LLC
Brief Summary

This study will evaluate the immediate antimicrobial efficacy and persistence of two hand hygiene products on ICU Health Care Worker's skin flora by measuring bacterial organisms on hands using the hand print method. It is hypothesized that the product containing Chlorhexidine gluconate will provide more persistence than the alcohol product, resulting in less bacterial growth on the hand print plates. In addition, environmental monitoring for cleanliness will be captured from high touch surfaces in ICU patient rooms and common areas using Rodac plates and adenosine triphosphate tests.

Detailed Description

Crossover study with 50 Health care workers using each product with a minimum of 3 days in between. Products will be applied twice as per manufacturer's instructions for a Healthcare Personnel Handwash followed by immediate hand print. Persistent hand prints will be collected after exposure to environmental contaminants in the common areas. Hand prints will also be collected from one hand of 60 patients cared for by a participating Health Care Worker and gloved hand of Health Care Worker. All media contain neutralizers to inactivate active ingredients in each product and on surfaces. Each hand print plate's area of growth will be measured for Colony Forming Units using computerized software.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
51
Inclusion Criteria
  • HCW willing to participate in the study
  • HCW willing to use non-Triclosan soap when soap is necessary throughout the study
  • HCW who will don gloves prior to ICU patient room entry
Exclusion Criteria
  • Use of any CHG -containing products ( liquid hand soap, Sage wipes) on the ICU 72 hours prior to study initiation and throughout study
  • HCW with patient bandage or other dressing on palm(s)
  • Known sensitivity or allergy to CHG or alcohols in hand hygiene products
  • Known sensitivity or allergy to the following components: Lecithin, Polysorbate 80,Trypticase Soy Agar, sodium bisulfate, sodium thioglycollate, sodium thiosulfate
  • History of skin allergies

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Alcohol hand sanitizer foamAlcohol hand sanitizer foamAlcohol foam hand sanitizer applied with 1 pump into hands, spread over hands up to the wrist and rubbed until dry. Foam will be applied twice approximately 15-30 minutes apart on one day.
hand antiseptic with CHG and alcoholhand antiseptic with CHG and alcoholHand antiseptic is applied by dispensing 1 pump into hands, spreading over the hands up to the wrist, and rubbing until dry. Hand antiseptic will be used twice approximately 15-30 minutes apart on one day.
Primary Outcome Measures
NameTimeMethod
Bacterial Colony Forming Units Present on Hand Prints After Time Spent in Common AreasOn each of 2 days, Hand print plates collected from one hand immediately after product use (T0) and from other hand after time spent in MICU common areas

Hand print plates will be collected from HCWs immediately after use of hand hygiene product and after time spent in common areas. Each HCW will use both products at least 3 days apart. Hand print plates from each product for each HCW will be compared.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Cleveland Clinic

πŸ‡ΊπŸ‡Έ

Cleveland, Ohio, United States

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