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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alcohol hand sanitizer foam | Active Comparator | 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. |
|
| hand antiseptic with CHG and alcohol | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hand antiseptic with CHG and alcohol | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abhishek Deshpande, MD, PhD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29382400 | Derived | 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. |
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Subjects were enrolled on the same day as treatment; subjects were required to meet inclusion/exclusion criteria to qualify for enrollment
Recruitment took place from October 2014-January 2015 at 3 MICUs within the same hospital
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| ID | Title | Description |
|---|---|---|
| FG000 | Alcohol + CHG First | Healthcare workers who received product with alcohol + CHG prior to product with alcohol only |
| FG001 | Alcohol Only First | Healthcare workers who received product with alcohol only prior to product with alcohol + CHG |
| FG002 | Patient | Patients received no treatment, but were cared for by healthcare workers who enrolled in the study |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Alcohol + CHG First | Healthcare workers who received product with alcohol + CHG prior to product with alcohol only |
| BG001 | Alcohol Only First | Healthcare workers who received product with alcohol only prior to product with alcohol + CHG |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | log(10) transformed CFU | 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 |
|
4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Alcohol + CHG First | Healthcare workers who received product with alcohol + CHG prior to product with alcohol only |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Specialist | 3M Health Care Business | 651-736-1578 | mdavid@mmm.com |
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| ID | Term |
|---|---|
| D064548 | Hand Sanitizers |
| D002864 | Chromogranins |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000891 | Anti-Infective Agents, Local |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
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|
|
| Alcohol hand sanitizer foam | Drug | 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 |
|
|
| BG002 | Patient | Patients received no treatment, but were cared for by healthcare workers who enrolled in the study |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Hand Antiseptic With CHG and Alcohol | 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. hand 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. |
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Alcohol Only First | Healthcare workers who received product with alcohol only prior to product with alcohol + CHG | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | Patient | Patients received no treatment, but were cared for by healthcare workers who enrolled in the study | 0 | 61 | 0 | 61 | 0 | 61 |
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| D020164 | Chemical Actions and Uses |
| D004202 | Disinfectants |
| D020313 | Specialty Uses of Chemicals |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |