Evaluation of Two Hand Hygiene Products in ICUs

Solventum US LLC

Status and phase: Completed; Phase 4

Conditions: Hand Hygiene Effectiveness

Treatments: Drug: Alcohol hand sanitizer foam; Drug: hand antiseptic with CHG and alcohol

Study type: Interventional

Funder types: Industry

Identifiers

NCT02258412

EM-05-013218

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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51 participants in 2 patient groups

Alcohol hand sanitizer foam

Active Comparator group

Description:

Alcohol 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.

Treatment:

Drug: Alcohol hand sanitizer foam

hand antiseptic with CHG and alcohol

Active Comparator group

Description:

Hand 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.

Treatment:

Drug: hand antiseptic with CHG and alcohol