Clinical trial NCT02258412: Evaluation of Two Hand Hygiene Products in ICUs
Official title: Evaluation of Antimicrobial Efficacy of Two Hand Hygiene Products in ICUs Using Hand Prints
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hand Hygiene Effectiveness
Keywords: antimicrobial
efficacy
hand
hygiene
bacteria
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2014-10-07
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bacterial Colony Forming Units Present on Hand Prints After Time Spent in Common Areas
timeFrame: On 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
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Abhishek Deshpande, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deshpande A, Fox J, Wong KK, Cadnum JL, Sankar T, Jencson A, Schramm S, Fraser TG, Donskey CJ, Gordon S. Comparative Antimicrobial Efficacy of Two Hand Sanitizers in Intensive Care Units Common Areas: A Randomized, Controlled Trial. Infect Control Hosp Epidemiol. 2018 Mar;39(3):267-271. doi: 10.1017/ice.2017.293. Epub 2018 Jan 31.