Hand Hygiene Effectiveness
Conditions
Keywords
antimicrobial, efficacy, hand, hygiene, bacteria
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.
Interventions
DRUGhand antiseptic with CHG and alcohol
HCWs will be randomized to use one product on one day and the other product on another day at least 3 days apart. Each product will be applied using 1 pump from its dispenser and rubbed over the hands until dry. Gloves will be worn while the HCW is in the patient room. Upon exit from the room, HCW will washoout with that same product. One imprint will be made of the non-dominant hand onto media containing neutralizers. That hand will be gloved with a white cotton glove. The HCW will work in the common areas with timing recorded. Upon leaving the common area, the dominant ungloved hand will be imprinted onto a fresh media plate containing neutralizers.
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
Sponsors
3M
Solventum US LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bacterial Colony Forming Units Present on Hand Prints After Time Spent in Common Areas | 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 | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment took place from October 2014-January 2015 at 3 MICUs within the same hospital
Pre-assignment details
Subjects were enrolled on the same day as treatment; subjects were required to meet inclusion/exclusion criteria to qualify for enrollment
Participants by arm
| Arm | Count |
|---|---|
| Alcohol + CHG First Healthcare workers who received product with alcohol + CHG prior to product with alcohol only | 26 |
| Alcohol Only First Healthcare workers who received product with alcohol only prior to product with alcohol + CHG | 25 |
| Patient Patients received no treatment, but were cared for by healthcare workers who enrolled in the study | 61 |
| Total | 112 |
Baseline characteristics
| Characteristic | Alcohol + CHG First | Alcohol Only First | Patient | Total |
|---|---|---|---|---|
| Age, Continuous | NA years | NA years | NA years | NA years |
| Region of Enrollment United States | 26 participants | 25 participants | 61 participants | 112 participants |
| Sex: Female, Male Female | NA Participants | NA Participants | NA Participants | NA Participants |
| Sex: Female, Male Male | NA Participants | NA Participants | NA Participants | NA Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 25 | 0 / 61 |
| other Total, other adverse events | 0 / 26 | 0 / 25 | 0 / 61 |
| serious Total, serious adverse events | 0 / 26 | 0 / 25 | 0 / 61 |
Outcome results
Primary
Bacterial Colony Forming Units Present on Hand Prints After Time Spent in 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.
Time frame: 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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Alcohol Hand Sanitizer Foam | Bacterial Colony Forming Units Present on Hand Prints After Time Spent in Common Areas | 2.17 log(10) transformed CFU |
| Hand Antiseptic With CHG and Alcohol | Bacterial Colony Forming Units Present on Hand Prints After Time Spent in Common Areas | 1.81 log(10) transformed CFU |