STERIS Skin Health Solutions

STERIS Skin
Health Solutions
Alcare Plus Antiseptic Handrub
with Emollients
®
Fast-acting Healthcare Personnel Handwash
Clinical Performance
Fast, Effective Antimicrobial Activity is a Mandatory Feature for Hand Hygiene Products
When used as a Healthcare Personnel Handwash (HCPH) or a Surgical Scrub (SS), Alcare Plus Antiseptic Handrub with
Emollients has demonstrated superior antimicrobial efficacy against both transient and resident flora in clinical studies.
The proven antimicrobial effectiveness of Alcare Plus Antiseptic Handrub makes it the hand hygiene product of choice
for healthcare workers to reduce risk of cross contamination after contact with pathogenic microorganisms encountered
in the healthcare environment.
Five Second MRSA Claim
Reduction of Methicillin-resistant Staphyloccocus aureus
ATCC#33591 in Five Seconds*
When tested in a modified Time Kill Study,
Alcare Plus® Antiseptic Handrub with
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Emollients demonstrated a 5.96 log
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reduction (99.999% reduction) in bacterial
count against MRSA in FIVE SECONDS!
FDA Standards for Clinical Performance
of a Healthcare Personnel Handwash
The Tentative Final Monograph for Health-Care
Average Log Reduction
10
Antiseptic Drug Products; Proposed Rule, (TFM)
published in the Federal Register June 17, 1994
5
Seco
MRSA Cnd
laim
!
Alcare Plus® (62% v/v)**
is the Food and Drug Administration’s (FDA) principle
regulation which sets the clinical performance standards
for antiseptic hand hygiene products in the healthcare industry.
The TFM identifies the proposed performance criteria for clinical efficacy of a healthcare personnel handwash (HCPH) as:
•
•
A 2-log reduction of transient bacteria from initial baseline microbial counts after the first application
A 3-log reduction of transient bacteria from initial baseline microbial counts after the tenth application
Clinical Performance of Alcare Plus Antiseptic
Handrub in a Healthcare Personnel Handwash
Study*
Performance of Alcare Plus Antiseptic Handrub
in a HCPH Study
The results from a clinical study conducted by an
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Plus Antiseptic Handrub meets the FDA proposed
performance standards of HCPH. Not all alcoholcontaining antiseptic handrubs are formulated to perform
at this level. An alcohol-based antiseptic handrub that is
formulated to meet the FDA performance standards such
as Alcare Plus Antiseptic Handrub can provide a greater
Average Log Reduction
independent laboratory demonstrated that Alcare
level of assurance for the healthcare worker.
Application 1
*Alcare® Plus Health Care Personnel Handwash Data Laboratory Report #310-306-6399
**in vivo testing in final formulation as “foam“
Application 10
Alcare Plus
TFM Standard
FDA Standards for Clinical Performance
for a Surgical Scrub
The TFM also identifies the proposed performance criteria
for clinical efficacy for a surgical scrub (SS) product as:
•
A surgical scrub must achieve a one log10 reduction
of microbial flora on day one within one minute of
use of a product
•
A two log10 reduction of microbial flora on day two
within one minute of use of product
•
A three log10 reduction of microbial flora on day
five within one minute of use of the product
•
The product should provide efficacy so that the
bacterial count on each hand does not subsequently
return to baseline within six hours on the first day.
Clinical Performance of Alcare Plus Antiseptic Handrub as a Surgical Scrub*
Alcare Plus Antiseptic Handrub exceeded the FDA’s proposed performance criteria for a Surgical Scrub on days one,
two, and five at the one minute time period and also demonstrated persistence by not allowing the resident flora to
return to baseline after six hours. The performance of Alcare Plus Antiseptic Handrub was equal to or superior to the
performance of the marketed 4% chlorhexidine gluconate (CHG) surgical scrub at both time points, one minute and six
hours after the use of the products. Alcare Plus Antiseptic Handrub achieved these results in the clinical study without
the use of scrub brushes.
Average Log Reduction
Performance of Alcare Plus Antiseptic Handrub
as a Surgical Scrub
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Day 1 One Minute
Day 1 Six Hours
Day 2 One Minute
Efficacy of Alcare® Plus Antiseptic Handrub with Emollients
as a Surgical Antisepsis/Hand Rub #310-301-6399
Day 2 Six Hours
Day 5 One Minute
Day 5 Six Hours
Alcare Plus
4% CHG
Broad Spectrum Antimicrobial
Performance in 15 Seconds
Reduction of Pathogenic Micro-organisms by Alcare Plus
Antiseptic Handrub in a Time Kill Study
A standard time kill
study demonstrates
the broad spectrum
antimicrobial
performance of
a hand hygiene
product. Alcare Plus
Antiseptic Handrub
significantly reduced
the bacterial counts of
transient pathogenic
organisms including
methicillin-resistant
Staphylococcus
aureus (MRSA) and
vancomycin-resistant
Enterococcus faecium
(VREF) within 15
seconds in a time
kill study.
Reference: Efficacy of Alcare® Plus Antiseptic
Handrub with Emollients Versus Pathogenic
Microorganisms Using a Time Kill Study
Laboratory Report #310-305-6399
ATCC #
Log10
Reduction
Percent Kill
Staphyloccocus aureus
6538
7.76
>99.999
Methicillin-resistant Staphylococcus aureus
33591
6.40
>99.999
Methicillin-resistant Staphylococcus aureus
33592
7.69
>99.999
Methicillin-resistant Staphylococcus aureus
33593
7.91
>99.999
Staphylococcus epidermidis
35983
7.60
>99.999
Staphylococcus epidermidis
12228
7.42
>99.999
Pseudomonas aeruginosa
15442
5.93
>99.999
Pseudomonas aeruginosa
9027
7.32
>99.999
Pseudomonas aeruginosa
14502
7.36
>99.999
Pseudomonas aeruginosa
27853
7.76
>99.999
Escherichia coli
8739
7.72
>99.999
Escherichia coli
26
7.84
>99.999
Escherichia coli
11229
7.07
>99.999
Escherichia coli
15221
7.56
>99.999
Enterococcus faecalis
27959
6.64
>99.999
Enterococcus faecalis
29212
6.93
>99.999
Enterococcus faecalis
29302
7.01
>99.999
Enterococcus faecalis
33186
7.17
>99.999
Clinical Isolate A
6.35
>99.999
Test Organism
Vancomycin-resistant Enterococcus faecium
Vancomycin-resistant Enterococcus faecium
Clinical Isolate E
6.68
>99.999
Vancomycin-resistant Enterococcus faecium
Clinical Isolate G
6.67
>99.999
Vancomycin-resistant Enterococcus faecium
Clinical Isolate G (2)
6.49
>99.999
Vancomycin-resistant Enterococcus faecium
Clinical Isolate H
6.29
>99.999
Klebsiella pneumoniae
8044
5.98
>99.999
Klebsiella pneumoniae
13883
7.92
>99.999
Klebsiella pneumoniae
27736
7.53
>99.999
Klebsiella pneumoniae
33452
7.69
>99.999
Serratia marcescens
14756
5.88
>99.999
Serratia marcescens
8195
8.12
>99.999
Streptococcus pyogenes
8058
6.83
>99.999
Streptococcus pyogenes
19615
6.43
>99.999
Streptococcus pyogenes
21059
6.27
>99.999
Candida albicans
10259
5.96
>99.999
Candida albicans
18804
5.73
>99.999
Candida albicans
24433
6.29
>99.999
Candida albicans
38483
6.63
>99.999
New Performance Standard
for Mildness
In today’s healthcare arena, antiseptic hand hygiene products must provide superior antimicrobial efficacy and be
mild to the skin with frequent use. Compliance with recommended hand hygiene practices depends on both of these
critical features.
Proven Moisturization Compared to Marketed Alcohol Handrubs
The results of Alcare Plus Antiseptic Handrub’s performance in this clinical study has laid to rest the urban legend that
“all alcohol handrubs are drying to the skin”. Alcare Plus Antiseptic Handrub provides superior moisturization to the
skin when compared to other marketed alcohol products. Alcare Plus improved skin hydration while other alcoholbased products had a negative impact on skin hydration. Alcare Plus Antiseptic Handrub demonstrated increased skin
hydration for up to two hours after a single application.
CDC Hand Hygiene
Guideline in
Health-Care Settings
Changes in Skin Hydration from Baseline at One and
Two Hours After One Application of Alcohol Handrubs
1-Hour
2-Hour
25 20 15 10 SKICON Units
“Provide personnel
with efficacious hand
hygiene products that
have low irritancy
potential, particularly
when these products
are used multiple
times per shift.”
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0
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-5 -10 -15 -20 Alcare Plus
Endure320
Advanced Care
Purell 2 in 1
Untreated Skin
Reference: Skin Moisturization Study with an Alcohol Hand Rub HTR Study: 04-123124-112
Damaged Hands Should Not be an Outcome of Compliance
Alcare Plus Antiseptic Handrub with Emollients is a foamed, alcohol-based healthcare personnel handwash. This
product contains 62% ethyl alcohol by volume providing fast-acting, broad-spectrum antimicrobial activity against
pathogenic microorganisms.
Meets proposed requirements of the FDA for efficacy
•
Healthcare Personnel Handwash
•
Broad-spectrum antimicrobial action, including MRSA and VRE
Meets recommendations of CDC for frequent-use products
•
New standard for mildness to encourage hand hygiene compliance
•
Moisturizes skin and prevents drying
•
Assures even distribution over skin surfaces
Chlorhexidine Gluconate
Clinical
Performance
Compatibility
The Value of Chlorhexidine Gluconate (CHG)
Chlorhexidine Gluconate (CHG) antiseptic wash products leave an antimicrobial chemical residual behind on
the skin after washing. The CHG residual has been demonstrated to provide (persistence) for up to six hours
as a surgical scrub. Customers desiring the performance and the residual persistent effect of CHG are paying
a premium for CHG products so it is important to ensure the persistence is not affected by other products
being used in the facility. Otherwise, the value of the CHG antimicrobial residual is being wasted.
The Importance of CHG Compatibility
Compatibility of Alcare Plus Antiseptic Handrub
with a CHG residual
Compatibility with the CHG residual is a “must” have
characteristic of waterless alcohol hand sanitizer products
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in those instances where CHG is the primary antiseptic
wash product used. Compatibility with CHG is demonstrated
application of a hand hygiene product compared to treatment
with CHG alone. In an in vitro skin model study, Alcare Plus
Antiseptic Handrub maintained the antimicrobial CHG residual
on the skin. Therefore, when using Alcare Plus in conjunction
with CHG products there are no concerns regarding
inactivation of the CHG residual.
Average Log Reduction
when there is no decrease in residual CHG activity following
CHG Residual
CHG Residual + Alcare Plus
Compatibility of CHG Residual with Alcare® Plus
Handrub and Cal Stat Laboratory Report #310-308-9412
Products Incompatible with CHG
Carbomer, a polymer commonly used to thicken alcohol handrubs,
can inactivate the CHG chemical residual on skin. Carbomercontaining alcohol handrubs have been demonstrated to inactivate
the antimicrobial CHG residual on the skin. 1Many waterless alcohol
hand sanitizers are thickened with carbomer polymers. It is important
when selecting an alcohol hand sanitizer to understand if the alcohol
product does contain polymers, then appropriate data is required to
prove that the product does not inactivate the CHG residual. Such
tests should be performed by testing bacterial counts on human
subjects after using a CHG wash product. This is followed by use of
the waterless alcohol hand sanitizer. Using the glove juice test, the
subject should then be tested for reduction in bacterial counts to
determine if the CHG residual is still activated following the use of the
hand sanitizer.
Alcare Plus contains no carbomers and does not inactivate the CHG
residual on the skin. In addition, the carefully chosen moisturizers
assure that Alcare Plus handrub provides great coverage, rubs in
quickly and leaves no greasy or sticky build-up as can be sometimes
found with carbomer products.
Average Log Reduction
Compatability of Marketed Alcohol Products with a CHG Residual
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CHG Residual
CHG Residual and Product A
(containing carbomer)
CHG Residual and Product B
(containing carbomer)
Kaiser N, Klein D, Karanja P, Greten Z, Newman J. Inactivation of Chlorhexidine Gluconate on Skin by Incompatible Alcohol
Hand Sanitizing Gels, American Journal of Infection Control, 2009; 37:569-73.
1
About STERIS Corporation
STERIS Corporation has been producing high quality drug, medical device and
specialty chemicals for over 70 years. Our vast experience in skin care, superior
regulatory and quality processes, and innovative research and development
professionals enable us to provide proven, optimal solutions for patient care and
health facility, research and critical environments.
STERIS meets critical standards:
•
cGMP quality systems complaint
•
ISO 9001/13485 registered
•
FDA establishment licensed
•
EPA establishment registered
The mission of STERIS Corporation is to provide a healthier today and a safer
tomorrow through knowledgeable people and innovative infection prevention,
decontamination and health science technologies, products and services. The
Company’s more than 5,000 dedicated employees around the world work
together to supply a broad array of solutions to healthcare, pharmaceutical,
industrial and government Customers.
Ordering Information
6399-P2
2.2 oz
48 per case
6399-57
5.4 oz
48 per case
6399-36
9 oz
24 per case
6399-90
17 oz
12 per case
T603-Q7
Wall bracket for 9 oz
24 per case
T516Q5
AFB - Aerosol Foam Bracket for17 oz / 9 oz
12 per case
clean.
For more information, please contact your STERIS account manager.
Printed with Soy based inks and water based
coatings on FSC/Green Seal-certified paper.
Document # M3141EN.2009-08, Rev. C
Printed 02/2010, 5000
©2009-2010 STERIS Corporation.
All rights reserved. Printed in USA.
STERIS Corporation
5960 Heisley Road
Mentor, OH 44060-1834 n USA
440-354-2600 n 800-548-4873
www.steris.com