The Evidence Is Clear

Transcription

3M Tegaderm CHG
TM
TM
Chlorhexidine Gluconate IV Securement Dressings
The Evidence
Is Clear
3M™ Tegaderm CHG Dressings
™
Clinical Evidence Summaries
02 | 03
INFECTION PREVENTION
™
™
3M Tegaderm CHG
integrates the powerful antimicrobial activity of Chlorhexidine
Gluconate with the high performance of Tegaderm dressing.
It has been specially developed to reduce skin flora which is
the most common source of CR-BSI.
Intelligent Infection Prevention at IV Sites
™
A Novel
Technology
for IV Infection
Prevention
For more than 30 years, 3M has been at the forefront of new
solutions for infection prevention. With the new innovative
Tegaderm CHG dressing, 3M expands the product portfolio and
offers a new look at IV site protection.
™
 Antimicrobial action
The innovative CHG gel pad provides powerful
antimicrobial action directly at the insertion
site to suppress skin flora.The effectiveness
of Tegaderm CHG was demonstrated in
a randomized controlled trial with healthy
volunteers.
™
1
 Transparent
The CHG gel pad and the Tegaderm dressing
are transparent and allow permanent visual
inspection of the IV site without having to
change the dressing.
™
 Long weartime – less changes
Tegaderm CHG presents antimicrobial action
over a 10-day period, allowing an optimal
dressing wear time up to 7-days according
to international guidelines.
™
 Absorbent
The CHG gel pad provides for absorbtion of
light drainage.
The innovative transparent CHG Gel Pad
• is very soft and conformable, maintaining
intimate contact between skin and CHG.
• CHG has been dissolved into a soft gel pad
to provide a reservoir for consistent and
continuous antimicrobial action over time.
The trusted Tegaderm™ transparent dressing
• with latex-free adhesive securely holds
catheters in place and is gentle to the skin.
• is a waterproof and breathable barrier to external
contaminations including liquids, bacteria, viruses
and yeasts.
• minimizes application errors, because of the easy to
use patented frame, the integrated gel pad and the
innovative design.
04 | 05
Proof of Antimicrobial Efficacy
Growth Inhibition of Microorganisms Involved in Catheter-Related Infections by an
Antimicrobial Transparent IV Dressing Containing Chlorhexidine Gluconate (CHG),
Hensler et al., 2009
6
Suppression of Regrowth of Normal Skin Flora Under Chlorhexidine
Gluconate (CHG) Dressings Applied to CHG-Prepped Skin, Bashir et al., 2008
10
an Antimicrobial Transparent IV Dressing Containing Chlorhexidine Gluconate (CHG),
A Novel integrated Chlorhexidine-impregnated Transparent Dressing for
Hensler et al., 2009
Prevention of Vascular Catheter-related Bloodstream Infection: A Prospective
Comparative Study in Healthy Volunteers, Maki et al., 2008
14
18
10
Prevention of Vascular Catheter-related Bloodstream Infection: A Prospective
Migration of Chlorhexidine Gluconate Under Antimicrobial Gel Pad of IV Securement
Dressing to Provide Continual Antimicrobial Protection, Schwab et al., 2008
6
Gluconate (CHG) Dressings Applied to CHG-Prepped Skin, Bashir et al., 2008
Antimicrobial Activity of a CHG-Impregnated Gel Pad for IV Site Protection,
Schwab et al., 2008
Growth Inhibition of Microorganisms Involved in Catheter-Related Infections by
22
Comparative Study in Healthy Volunteers, Maki et al., 2008
14
Antimicrobial Activity of a CHG-Impregnated Gel Pad for IV Site Protection,
Schwab et al., 2008
Clinical Practice
18
Migration of Chlorhexidine Gluconate Under Antimicrobial Gel Pad of
Clinical Performance
IV Securement Dressing to Provide Continual Antimicrobial Protection,
A Preliminary European Evaluation on the Clinical Performance of
Schwab et al., 2008
the CHG Antimicrobial Transparent Dressing, 3M data on file, 2009
28
The Use of Chlorhexidine Gluconate (CHG) on Central Line Insertion Sites:
Disk versus Gel Pad Dressing, Meninger et al., 2009
34
Evaluation of Tegaderm™ CHG Dressings for Catheter Care, Zehrer et al., 2009
38
Prospective, Randomized, Controlled Trial Assessing the Clinical Performance
of a Transparent Chlorhexidine Gel Pad Intravascular Catheter Dressing,
Rupp et al., 2008
44
Clinical Effectiveness
Accomplishing Zero Bloodstream Infections with Chlorhexidine
Gluconate Transparent IV Securement Dressing, Gould et al., 2010
48
Strategies to Eliminate Catheter-Related Bloodstream Infections, Pappas et al., 2009 52
Effect of Chlorhexidine Gluconate (CHG) Gel Dressing on Adult Central Venous
Line-Related Primary Bloodstream infections, Reilley, 2009
56
Health Economics
Economic Evaluation of Antimicrobial IV Dressings, Brenner, 2009
60
Product Information
66
22
PROOF OF ANTIMICROBIAL EFFICACY
Proof of
Antimicrobial Efficacy
Table of Contents
06 | 07
Growth Inhibition of Microorganisms Involved in Catheter-Related
Infections by an Antimicrobial Transparent IV Dressing Containing
Chlorhexidine Gluconate (CHG)
J.P. Hensler, 3M Health Care, et al.
Poster at the conference of European Society of Clinical Microbiology and Infectious Diseases (ECCMID),
May 2009.
3M™ Tegaderm™ transparent film integrated
with CHG serves as a barrier to organisms
including those most commonly associated
with CR-BSIs.
7%
7%
39%
™
Tegaderm CHG Dressings Provide
Defense against Microorganisms that
Cause CR-BSIs
Purpose
The purpose of this study was to evaluate the
antimicrobial activity of Tegaderm CHG Dressings against
microorganisms commonly associated with CR-BSIs using
in vitro zone of inhibition.
7%
COAGULASE-NEGATIVE
STAPHYLOCOCCI
STAPHYLOCOCCUS AUREUS
ENTEROBACTER SPP.
CANDIDA SPP.
KLEBSIELLA SPP.
PSEUDOMONAS SPP.
ENTEROCOCCUS SPP.
10%
10%
20%
™
Key Points
AVERAGE ZONE
GEL DIAMETER (24 MM)
Enterococcus epidermidis 1228
60
Corynebacterium diphtheriae 13812
Skin organisms
at the insertion
site are the most
common source
of catheter
colonization.
 The Tegaderm CHG Dressings demonstrated
broadspectrum antimicrobial activity against
the 37 strains of microorganisms – 21 gram
positive and 14 gram negative bacteria and 2
yeasts – that most commonly cause catheterrelated bloodstream infections (CR-BSIs).
™
 The Tegaderm CHG gel pad produced a
clear region on agar that shows the absence
of microbial growth (zone of inhibition).
The dressing’s antimicrobial agent (CHG)
exceeded the concentrations needed to
inhibit each of the microorganisms tested.
™
Enterococcus faecalis
Wound Isolate #23
Enterococcus
faecalis 19433
Enterococcus
faecalis 7080
Enterococcus
faecium (MDR) 51559
30
Staphylococcus
epidermidis 14990
20
10
Staphylococcus
epidermidis
(MRSE) 51625
Staphylococcus
epidermidis (MRSE)
nasal isolate #492
Staphylococcus
aureus 25923
Staphylococcus aureus
Nasal Isolate #849
(MRSA/GRSA) 33592
(MRSA) USA 100
(MRSA) USA 300
(MRSA) USA 800
(MRSA) USA 500
(MRSA) USA 600
Acinetobacter baumannii 19606
Candida albicans 10231
40
35
30
25
GRAM NEGATIVE & YEAST
Acinetobacter baumannii BAA-747
Acinetobacter baumannii BAA-747
20
Proteus mirabilis 7002
15
Pseudomonas aeruginosa 10145
10
5
Proteus mirabilis 12453
 Aged Tegaderm CHG Dressings retain their
antimicrobial properties as well as unaged
dressings.
50
Enterococcus
faecium (VRE) 700221
Candida albicans 58716
GRAM POSITIVE
Staphylococcus epidermidis 13518
Staphylococcus
epidermidis 49461
Staphylococcus
epidermidis 49134
40
™
Escherichia coli 25922
Klebsiella pneumoniae 23357
Klebsiella pneumoniae 13883
Protects against
the most
common strains
of CR-BSI-causing
microorganisms
Enterobacter cloacae 35549
The Zone of Inhibition is the clear region on
agar that shows the effective inhibition of
microbial growth by an antimicrobial agent.
The spider-web diagrams represent the
diameter of the zone of inhibition around the
gelpad.
Effective against
a wide array of
broad-spectrum
micro-organisms,
including multiple
antibiotic resistant
organisms.
08 | 09
Study Conducted to Evaluate Antimicrobial
Efficacy of 3M Tegaderm CHG Dressings
™
™
The primary purpose of this study was to evaluate the antimicrobial activity of
Tegaderm™ CHG Dressings against the 37 strains of microorganisms commonly
associated with CR-BSIs using in vitro zone of inhibition.
The study measured the zones of inhibition around:
• New Tegaderm™ CHG Dressings
Effective against
most common
pathogens
causing CR-BSI.
• Aged Tegaderm™ CHG Dressings (dressings were subject to standard ICH aging
conditions for 22 months)
Tegaderm CHG Dressings Protect against the
37 Strains of CR-BSI-causing Microorganisms
™
The Tegaderm™ CHG Dressings demonstrated antimicrobial activity against all 37
strains of microorganisms commonly associated with CR-BSIs. Additionally, the
Tegaderm™ CHG gel pad produced a circular zone of inhibition in which the amount of
CHG measured exceeded the amount necessary to inhibit each of the microorganisms
tested.
Aged Tegaderm™ CHG Dressings retained their antimicrobial properties as well as new
dressings. The aged dressings produced similar zones of inhibition compared to new
dressings.
Notes:
10 | 11
Gluconate (CHG) Dressings Applied to CHG-Prepped Skin
M.H. Bashir, MICROBIOTEST, Inc., et al.
Poster at the ICAAC, American Society for Microbiology and Infectious Diseases of America
(IDSA), October 2008.
™
4.0
®
3.5
Purpose
The purpose of this study was to compare the skin
organism suppression performance of Tegaderm CHG
Dressings versus BIOPATCH .
™
®
BIOPATCH ®
TEGADERM™ CHG
DRESSING
TEGADERM™ DRESSING
(CONTROL)
™
3.0
2.5
2.0
**
1.5
**
*
**
1.0
0.5
N=31
31
31 31 31
BASELINE POST-PREP DAY 1
30 30 30
DAY 4
30 29 30
DAY 7
 Skin organisms remain and will regrow even
after prepping with a CHG prep.
 Tegaderm CHG Dressings had significantly
lower skin organism regrowth than a
standard transparent adhesive dressing.
™
™
®
1.2
BIOPATCH ®
TEGADERM™ CHG DRESSING
POST-PREP
TEGADERM DRESSING (CONTROL)
™
Skin flora rebound over time, even after
prepping with a CHG prep. Line plot of
log regrowth values by day. Skin prep
was ChloraPrep . Error bars represent the
standard error of the mean.
®
MEAN LOG REGROWTH LOG10 CFU/CM
 At 7 days, Tegaderm CHG Dressings had
significantly lower skin organism regrowth
than BIOPATCH .
1.4
2
CR-BSIs
can lead to
increased
length of
hospitalization,
illness and
death.
Maintained
lower skin
organism counts
than BIOPATCH
®
0.0
Key Points
** represents p-values < 0.001, * p-values
< 0.01. One subject had baseline <2.5
log10 CFU/cm2, one had dressings lost by
day 4 and one lost BIOPATCH by day 7. All
pairwise testing done against Tegaderm
CHG Dressing using a paired t-test with
Holm stepwise adjustment for multiple
comparisons.
®
MEAN LOG COUNT LOG10 CFU/CM2
Tegaderm CHG Dressings Outperforms
BIOPATCH in Skin Flora Regrowth on
Prepped Skin
1.0
0.8
Maintained
significantly
lower regrowth
than BIOPATCH
0.6
0.4
0.2
®
0.0
-0.2
0
1
2
3
DAY
4
5
6
7
12 | 13
Study Conducted to Compare Antimicrobial
Effectiveness: Tegaderm CHG Dressings versus
BIOPATCH
Notes:
™
®
Although the use of CHG to disinfect the skin prior to catheter insertion provides
substantial protection, viable bacteria may still remain on the skin and regrow over
time.
Skin organisms
remain and will
regrow even after
prepping with a
CHG prep.
The primary objective of this study was to demonstrate that Tegaderm™ CHG Dressings
maintain suppression of regrowth of skin organisms better than standard transparent
adhesive dressings when used to secure catheters over CHG-containing skin
preps in a healthy subject population. The secondary objective was to compare the
performance of Tegaderm™ CHG Dressings to BIOPATCH .
®
The study was conducted as follows:
• The backs of 32 healthy subjects were prepped with a CHG skin prep (ChloraPrep )
®
in four test areas.
• All dressing types (Tegaderm™ dressing, Tegaderm™ CHG Dressing and
BIOPATCH ) and a post-prep site were randomized within each area.
®
• Dressings were removed by area on days 1, 4 and 7, followed by skin organism
sampling.
• Cultures were obtained using the Williamson Kligman scrub cup technique, which is
designated by the FDA as the technique of choice for skin flora sampling.
• Suppression of regrowth between all dressings was determined by comparing skin
organism counts on days 1, 4 and 7.
Tegaderm CHG Dressings Maintained Lower Skin
Organism Counts than Other Dressings
™
This study found:
• The control dressing (standard transparent dressing) showed the largest regrowth on
all days sampled.
• The Tegaderm™ CHG Dressings maintained significantly lower counts than the
control dressing on all days sampled.
• After 7 days, skin organism counts under the Tegaderm™ CHG Dressings were
significantly lower than those under BIOPATCH . The difference between
®
Tegaderm™ CHG and BIOPATCH at day 7 was, on average, 0.45 log10 CFU/cm .
®
2
14 | 15
Prevention of Vascular Catheter-related Bloodstream Infection:
A Prospective Comparative Study in Healthy Volunteers
Dr. Dennis Maki, University of Wisconsin School of Medicine and Public Health, et al.
Poster at the conference of the Society for Health Care Epidemiology of America, April 2008.
™
4.0
®
3.5
Purpose
The purpose of this study was to compare
the antimicrobial effectiveness of Tegaderm
CHG Dressings to that of BIOPATCH .
™
®
BIOPATCH ®
TEGADERM™ CHG
DRESSING
3.0
LOG CFU/CM 2 ± SEM
Tegaderm CHG Dressings Outperform
BIOPATCH in Skin Flora Regrowth
2.5
2.0
1.5
1.0
0.5
0.0
Key Points
Provides
superior
progressive kill
to BIOPATCH
®
0
1
2
3
4
5
DAYS
6
7
8
9
10
 Tegaderm CHG Dressings provide excellent
kill of skin organisms in vivo on healthy adult
subjects.
™
4.0
 On skin prepped with 70% Isopropyl alcohol
alcohol, Tegaderm CHG Dressings showed
significantly lower regrowth at day 7
compared to BIOPATCH .
TEGADERM™ CHG
DRESSING
BIOPATCH ®
TEGADERM™
DRESSING (CONTROL)
3.5
BASELINE
SKIN FLORA
™
®
 Tegaderm CHG Dressings are superior
to BIOPATCH in providing progressive
kill of skin organisms on unprepped sites
at all times.
™
®
3.0
LOG CFU/CM 2 ± SEM
The most
frequent lifethreatening
complication of
vascular access
is CR-BSI
In vivo time kill of normal flora on unprepped
skin with the two CHG-impregnated dressings
on healthy adult volunteers. The likelihoodbased repeated measures analysis, which
included both dressing and time in the model,
showed Tegaderm™ CHG Dressing to be
®
significantly more effective than BIOPATCH
in reducing floral counts on unprepped skin
across all time points (P=0.008).
2.5
2.0
1.5
POST-PREP
COUNT
1.0
0.5
0.0
Suppression of regrowth on prepped subclavian
sites with the two CHG-impregnated dressings on
healthy adult volunteers. At day 7, Tegaderm™ CHG
dressings showed significantly lower regrowth
post prep compared to the control (p<0.0001). At
day 10, both CHG-impregnated dressings showed
significantly lower regrowth (p<0.0003). There
was a statistically significant difference between
®
Tegaderm™ CHG Dressings and BIOPATCH
at day 7 (log10 cfu 0.80, P<0.02). Since the skin
has been prepped with alcohol
(no persistant effect)
BASELINE POST-PREP
DAY 7
DAY 10
After prepping with
alcohol the suppression of regrowth can
be attributed to the
dressings only
16 | 17
CHG Dressings Maintain Low Skin Organism
Counts
Tegaderm CHG Dressings Provide Excellent
In Vitro Kill
Chlorhexidine Gluconate (CHG) has been used widely throughout the world for more
The Tegaderm™ CHG Dressings provided excellent in vitro kill when microorganisms
than 50 years for cutaneous disinfection, hand hygiene and oral hygiene. The safety of
were applied to the CHG surface of the dressings. These reductions were achieved
1
™
2-4
CHG is well established. Bacterial resistance to CHG has been very rare.
™
Tegaderm CHG
Dressings were
significantly
more effective
than BIOPATCH
in reducing skin
organism counts
on unprepped
skin across all
time points.
®
after 15 minutes of exposure for 12 of the 15 strains of bacteria.
While the use of CHG as a skin prep is an effective antiseptic technique for temporary
reduction of skin organisms, the CHG becomes inactive over time allowing skin
organisms to regrow under the dressing.5 Tegaderm™ CHG Dressings and BIOPATCH
®
maintain low skin organism counts beyond 48 hours of antimicrobial activity of the
CHG skin prep.
Tegaderm CHG Dressings Suppress Skin
Organism Regrowth Better than BIOPATCH
™
®
A study was conducted to assess the capacity of Tegaderm™ CHG Dressings and
Both provide the following benefits:
BIOPATCH to suppress skin organism regrowth following cutaneous prepping for 1
®
• Kill skin organisms
minute with 70% isopropyl alcohol. Both were left on for 7 or 10 days.
• Suppress regrowth of skin flora
• Provide broad-spectrum activity6
At day 7 of the trial, the Tegaderm™ CHG Dressings showed significantly lower
• Offer long term antimicrobial activity (tested up to 10 days)
regrowth post prep compared to the control dressing. Additionally, the Tegaderm™ CHG
6
• Continue to be effective in the presence of blood, saline, and exudates
Dressings showed a significantly lower regrowth at day 7 compared to BIOPATCH . At
®
day 10, both the Tegaderm™ CHG Dressings and BIOPATCH showed significantly lower
®
regrowth compared to the non-antimicrobial dressing.
Study Conducted to Compare Antimicrobial
Effectiveness: Tegaderm CHG Dressings versus
BIOPATCH
™
A study was conducted to assess the capacity of Tegaderm™ CHG Dressings and
BIOPATCH to reduce skin organisms on unprepped skin. Both were left on for 10 days.
®
®
In comparing bacterial reductions over time, the Tegaderm™ CHG Dressings had
higher average reductions compared to BIOPATCH at each day. These differences only
®
The purpose of this study was to compare the antimicrobial effectiveness of
Tegaderm CHG Dressings to that of BIOPATCH . Three methods were used:
™
achieved statistical significance at day 1 and day 4. However, the Tegaderm™ CHG
®
1. In vitro measurement of immediate surface antimicrobial activity (quantitative kill
Dressings were significantly more effective than BIOPATCH in reducing skin organism
®
counts on unprepped skin when measured across all time points (p>0.008).
over 15 minutes) of a Tegaderm™ CHG Dressing and a non-medicated polyurethane
dressing.
2. In vivo analysis of prevention of skin organism regrowth by Tegaderm™ CHG
Dressings and BIOPATCH on alcohol prepped subclavian sites.
®
3. In vivo analysis of progressive kill of skin organisms by Tegaderm™ CHG Dressings
and BIOPATCH on unprepped sites over 10 days of exposure.
®
Cultures were obtained using the Williamson Kligman scrub cup technique, which
is designated by the FDA as the technique of choice for skin flora sampling.
Referenced Articles
1. Milstone AM, Passaretti CL, Perl TM. Chlorhexidine: expanding the armamentarium for infection control
and prevention. Clin Infec Dis. 2008;46:274-81.
2. McDonnell G, Russell AD. Antiseptics and disinfectants: activity, action and resistance. Clin Microbiol Rev.
1999; 12(1): 147-79.
3. Stickler DJ, Thomas B, Clayton CL, Chawla JC. Studies of the genetic basis of chlorhexidine resistance. Br
J Clin Pract. 1983;25:23-30.
4. Russell AD. Principles of antimicrobial activity and resistance. In Disinfection, Sterilization and
Preservation, ed. Seymour S. Block. Lippincot Williams & Wilkins, Philadelphia, PA, 2001;47-49.
5. Hendley, JO, Ashe, KM (1991). Effect of topical antimicrobial treatment on aerobic bacteria in the stratum
corneum of human skin. Antimicrobial Agents and Chemotherapy. 35 (4), pp. 627-631.
6. Denton, GW: Chlorhexidine. In Disinfection, Sterilization and Preservation, ed. Seymour S. Block. Lippincot
Williams & Wilkins, Philadelphia, PA, 2001; p. 321-336.
18 | 19
Antimicrobial Activity of a CHG-Impregnated Gel Pad
for IV Site Protection
Debra Schwab, 3M Senior Research Microbiologist, et al.
Poster at the conference of Infusion Nursing Society, May 2008.
Antimicrobial Effectiveness of Tegaderm
CHG Gel Pad Compared to BIOPATCH
TEGADERM™ CHG GEL PAD
™
Purpose
The purpose of this study was to compare the in vitro
antimicrobial effectiveness of Tegaderm CHG Dressings
to that of BIOPATCH .
™
®
12.0
10.0
ZONE OF INHIBITION BEYOND GEL PAD (MM)
®
BIOPATCH® DISK
Key Points
The bars represent the mean widths of the
inhibition zones around each sample before
they were transferred to freshly inoculated
agar plates. Standard deviations for the three
replicates are noted by the error bars.
Note: CHG gel pad was cut to the same size
as BIOPATCH .
®
8.0
Zones of
inhibition were
similar over time
6.0
4.0
2.0
0.0
1
2
3
4
5
6
7
8
9
10
DAY
 The zone of inhibition of Tegaderm CHG gel
pad as compared to that of BIOPATCH were
equivalent every day up to 10 days.
™
®
 CHG antimicrobial protection is readily
available from the Tegaderm CHG gel pad
without any additional moisture.
 CHG from the Tegaderm CHG Dressings
diffused under the catheter.
In vitro tests demonstrate the availability and
sustained release over a 10-day period. In
this study, the same Tegaderm CHG gel pad
was transferred daily onto an agar spread
with 4 to 5 logs of bacteria. The reservoir of
CHG within the gel pad was as available and
as effective at Day 10 as Day 1.
™
™
™
TEGADERM™ CHG GEL PAD
12.0
10.0
ZONE OF INHIBITION BEYOND GEL PAD (MM)
The challenge
is providing
continuous
antimicrobial
protection without manipulating
the catheter.
8.0
Provides
continuous
protection
over time
6.0
4.0
2.0
0.0
1
2
3
4
5
6
DAY
7
8
9
10
20 | 21
Studies Conducted to Compare Antimicrobial
Efficacy: 3M Tegaderm CHG Dressings
versus BIOPATCH
™
Summary of Results
™
®
Method 1: Tegaderm™ CHG Dressings and BIOPATCH had Zones of
®
Inhibition for 10 Days
The purpose of these studies was to compare the in vitro antimicrobial effectiveness of
Zones of inhibition on agar from the Tegaderm™ CHG Dressings and BIOPATCH were
Tegaderm™ CHG Dressings to that of BIOPATCH . Gel pads were cut to the same size as
observed on all 10 days. The zone sizes were comparable between the Tegaderm™
BIOPATCH . Three methods were used.
CHG Dressings and BIOPATCH .
®
®
®
®
Method 2: Tegaderm™ CHG Dressings Transfer CHG in Dry Conditions
Tegaderm
CHG Dressings
transfer CHG
faster than
BIOPATCH .
™
METHOD 1
Sustained Activity
METHOD 2
Surface Availability
METHOD 3
CHG Diffusion
The presence of CHG on the
surfaces of the Tegaderm™
CHG gel pad and the
BIOPATCH , in the absence
of additional moisture, was
evaluated. CHG activity would
be demonstrated by a zone of
inhibition.
The diffusion of CHG from the
Tegaderm™ CHG Dressing’s
gel pad through the agar to
areas not in direct contact
with the agar surface was
demonstrated.
CHG antimicrobial protection was found to be readily available from the Tegaderm™
CHG gel pad without any additional moisture. The BIOPATCH did not transfer CHG
®
Tegaderm™ CHG gel
pads were compared to
BIOPATCH for sustained in
vitro activity over 10 days.
®
®
®
under these dry conditions.
Method 3: CHG from Tegaderm™ CHG Dressings Diffused Under
the Catheter
This study demonstrated the diffusion of CHG from the gel pad through the agar to areas
not in direct contact with the agar surface. This finding shows that the Tegaderm™ CHG
1. Tegaderm™ CHG gel
pads and BIOPATCH
were placed onto
agar surfaces covered
with Staphylococcus
epidermidis. They
incubated overnight
at 35°C.
®
2. The clear zones
surrounding the gel pads
and disks were measured
and recorded.
3. Each sample was
transferred daily to agar
plates freshly inoculated
with bacteria and incubated
overnight. This was
repeated for 10 days.
1. Dry polypropylene
membranes were placed in
contact with the surfaces
of the Tegaderm™ CHG
gel pad and BIOPATCH
for one hour at ambient
temperature.
®
2. The membranes were
then transferred onto
the surfaces of MH
agar inoculated with S.
epidermidis and incubated
overnight at 35°C.
3. The membranes were
removed to observe the
growth of the bacteria
within the agar.
Day 1: A section of catheter
was cut and placed directly
onto agar. A CHG gel pad was
laid over the catheter. The
plate was incubated for 24
hours at 35°C.
Day 2: The gel and catheter
section were removed from
the plate. A suspension of
S. epidermidis was spread
over the plate’s surface and
incubated for an additional
24 hours at 35°C.
Day 3: The plate surface was
observed for growth within
the zone of inhibition.
Dressings provide antimicrobial activity also under the catheter.
22 | 23
Migration of Chlorhexidine Gluconate Under Antimicrobial Gel Pad of IV
Securement Dressing to Provide Continual Antimicrobial Protection
Debra Schwab, 3M Senior Research Microbiologist, et al.
Association for Vascular Access, September 2008.
% CHG UNDER CATHETER
™
Tegaderm CHG Dressings Provide
Continuous Release of the Antimicrobial
Substance Under the Catheter
90
80
70
% CHG RECOVERY
Purpose
The purpose of this study was use the matrix-assisted
laser desorption/ionization (MALDI) technique to measure
CHG migration under the catheter.
CHG on skin recovered from underneath
catheters, shown as average ratios of signal
intensities under catheter/Tegaderm™ CHG
gel pad (n=6).
The longer the
patient wears
the dressing, the
more CHG is
present under
the catheter
60
50
40
30
20
10
0
Key Points
-10
Provides
continuous
antimicrobial
protection
around the
catheter without
excessive
manipulation.
 This novel test method was successful
in evaluating and demonstrating, for the
first time, the presence of CHG in very fine
increments on the skin.
 Skin recovered from under the catheters
showed the presence of CHG in 24 hours.
 Tegaderm CHG Dressings provided CHG
levels on the skin that increased with time.
™
 Tegaderm CHG Dressings placed over
a catheter site provided continuous
antimicrobial protection without excessive
manipulation or intrusion under the catheter.
™
1
2
4
STUDY DAYS
7
24 | 25
Study Conducted to Show CHG Migrates Under the
Catheter
The purpose of this study was to demonstrate that CHG is able to migrate under the
catheter, showing that the skin under the catheter is protected with CHG from the
Tegaderm™ CHG gel pad.
Microbiological methods were assessed and lacked precision and sensitivity
CHG migrates
under the
catheter.
for this study. Agar methods are not true reflections of what happens on
drier sites such as skin; cup scrub methods are applicable for large areas;
and swabs have poor recovery. The MALDI analytical method was used for
its potential sensitivity in imaging CHG on skin recovered by tape lifting.
CHG Migration from Tegaderm CHG Dressings
Under the Catheter
™
This study demonstrated the presence of CHG on skin under catheter pieces when a
Tegaderm™ CHG Dressing was placed over a catheter site. According to study results,
the Tegaderm™ CHG Dressings provided more complete antimicrobial protection.
The amounts of CHG recovered from the skin show that the longer the patient wears
the dressing the more CHG is present under the catheter.
Notes:
26 | 27
Notes:
Clinical
Practice
A Preliminary European Evaluation on the Clinical Performance of
the CHG Antimicrobial Transparent Dressing, 3M data on file, 2009
27
The Use of Chlorhexidine Gluconate (CHG) on Central Line Insertion Sites:
Disk versus Gel Pad Dressing, Meninger et al., 2009
33
Evaluation of Tegaderm™ CHG Dressings for Catheter Care, Zehrer et al., 2009
37
Prospective, Randomized, Controlled Trial Assessing the Clinical Performance
of a Transparent Chlorhexidine Gel Pad Intravascular Catheter Dressing,
Rupp et al., 2008
43
Gluconate Transparent IV Securement Dressing, Gould et al., 2010
47
Strategies to Eliminate Catheter-Related Bloodstream Infections, Pappas et al., 2009 51
Effect of Chlorhexidine Gluconate (CHG) Gel Dressing on Adult Central Venous
Line-Related Primary Bloodstream infections, Reilley, 2009
55
Health Economics
Economic Evaluation of Antimicrobial IV Dressings, Brenner, 2009
59
CLINICAL PRACTICE
28 | 29
CLINICAL PERFORMANCE
A Preliminary European Evaluation on the Clinical Performance of the
CHG Antimicrobial Transparent Dressing
3M data on file
15 Hospitals in 10 European Countries
Evaluated the Overall Performance of
Tegaderm CHG
ALL CENTERS
N
MUCH BETTER
BETTER
SAME AS
WORSE
5
4
3
2
1
43,55 %
32,26 %
0,00 %
0,00 %
Teg CHG Evaluation 2010
MUCH WORSE
62
24,19 %
Intuitive to use
50
18,00 %
38,00 %
42,00 %
2,00 %
0,00 %
Time to Apply
61
9,84 %
19,67 %
59,02 %
11,48 %
0,00 %
Visibility IV site
61
24,59 %
44,26 %
29,51 %
1,64 %
0,00 %
Absorption of Fluid
53
35,85 %
35,85 %
26,42 %
1,89 %
0,00 %
Fixation of Catheter
56
44,64 %
44,64 %
8,93 %
1,79 %
0,00 %
Removal from Skin
54
5,56 %
25,93 %
62,96 %
3,70 %
1,85 %
The primary aim of this study was to evaluate the following performance indicators
Removal from Catheter
52
5,77 %
32,69 %
53,85 %
5,77 %
1,92 %
of the CHG antimicrobial Transparent Dressing (Tegaderm™ CHG) in clinical settings
Skin condition removal
56
16,00 %
48,00 %
34,00 %
2,00 %
0,00 %
Wear time / Adherence
55
45,45 %
43,64 %
9,09 %
1,82 %
0,00 %
Overall Performance
54
25,93 %
62,96 %
11,11 %
0,00 %
0,00 %
Aim of the study
among skilled nurses: ease of dressing application and removal, adhesion and wear
times, fixation and security of the catheter, protection of the CVC site.
94% of the
evaluators
recommend the
use of Tegaderm
CHG. Almost
90% rated it as
better or much
better than the
I.V. dressing
rountinely used.
Conclusion
Over 85% of respondents evaluate
Tegaderm(tm) CHG as better or much better
than their current dressing
 Overall performance of the integrated
transparent absorbent CHG gel dressing was
rated significantly better than their currently
used baseline dressing
Evaluation of
Tegaderm CHG
versus baseline
dressing.
™
 There was a strong indication that the IV
nurses participating in this study were willing
to replace their current dressing system with
the integrated transparent absorbent CHG gel
dressing
 The integrated transparent absorbent CHG gel
dressing was rated better than their currently
used dressing in severall of the specific
performance comparisons pertaining to:
Ease of Application, Visibility of IV site,
Fixation of the IV catheter, Wear time and
adherence.
PIE CHART OF CURRENT DRESSING
CATEGORY
1,6 %
MEPORE
COSMOPOR E
IV 3000 1H
TEGADERM IV
6,6 %
29,5 %
62,3 %
Overview baseline
dressings.
Ease of application
30 | 31
Background
The density of skin flora at the catheter insertion site is a major risk factor for CLABSI
CHART OF RECOMMEND
and the majority of CLABSIs originate from the patient’s own skin flora. Among
80
has been included in the top five performance indicators for reducing CLABSI
70
(recommendation CDC). Transparent dressings protect the insertion site and act as
60
a barrier to external contamination, but allow visual inspection without removing
50
the dressing. A new product has been developed that combines the benefits of a
PERCENT
the strategies found to be successful in reducing CLABSI, the use of chlorhexidine
transparent dressing and chlorhexidine: a transparent dressing with an integrated gel
40
30
pad which contains 2% CHG.
20
10
6%
0
NO
YES
Methods
RECOMMEND
Study Design
• A multicenter study design was used. During a minimum 14 day period, nurses used
CHART OF CONFORM / FIXATION
an integrated Transparent Absorbent CHG Gel dressing to cover the I.V. site instead of
5
Comparison between Tegaderm™ CHG and
baseline dressing: Fixation of catheter.
80
80
70
PERCENT
Outcome Measures
• Secondary Endpoints:
3
4
transparent
non transparent
90
were included in the study.
• Primary endpoints: Nurse evaluation of overall dressing performance
2
5 = much better; 1 = much worse
their current used dressing (= baseline dressing): Only adult patients with CVCs
60
50
46
40
• Ease of applying over I.V. Site
30
• Intuitive to use
20
• Time required to apply dressing
10
• Ability to visualize the I.V. site
42
20
10
2
0
2
• Ability to absorb fluid
3
4
5
CONFORM / FIXATION
• Ability to conform and fixate the catheter.
• Ease of removal from skin and catheter.
• Patient skin condition a removal
• Overall adherence and wear time
CHART OF WEAR TIME / ADHERENCE
New dressing was compared with the baseline dressing using a five point Likert
2
5 = much better; 1 = much worse
scale (1 to 5; much worse to much better).
non transparent
50
50
3
50
40
62 evaluators from 15 hospitals in 10 countries participated in this clinical evaluation
(ICU, Dialysis, Oncology, General ward). 257 Tegaderm CHG dressings were applied
and evaluated during the study period.
30
20
10
10
2
0
2
3
4
4
5
46
44
transparent
Facilities and Participants
PERCENT
Transparency
and antimicrobial
activity:
A powerful
combination
providing
permanent
visual
assessment
of the exit-site
and skin flora
suppression
Would you recommend this dressing?
94%
90
5
WEAR TIME / ADHERENCE
Comparison between Tegaderm™ CHG and
baseline dressing: Wear time / Adherence.
32 | 33
Participating Hospitals
Klinikum Nurnberg Nord, Germany
Univ. Klinikum Erlangen, Germany
Uniklinik Hamburg, Germany
BG Unfallklinik Duisburg, Germany
Faculty Hospital Plzen, Czech Republic
St Jan Hospital Brugge, Belgium
RSC Hospital, United Kingdom
Centre Hospitalier Melun, France
Centre Hospitalier M. Jacques, France
ASK Hospital Wroclaw, Poland
Herlev Hospital, Denmark
Instituto Clinico Humanitas, Italy
Valme, Sevilla, Spain
Attico University Hospital, Athens, Greece
St. Savas Anticancer Hospital, Athens Greece
Results
• 88.9% of the evaluators rated the overall performance of the integrated
transparent absorbent Tegaderm™ CHG gel dressing as better or much better than
the baseline dressing
• 89.1% of the evaluators rated the wear time of the Tegaderm™ CHG as better or
much better.
• 94.0% of evaluators would recommend the CHG Antimicrobial Transparent
Dressing (Tegaderm™ CHG).
References
- Safdar N, Maki DG. Risk of catheter-related bloodstream infection with peripherally inserted central venous
catheters used in hospitalized patients. Chest 2005;128(2):489-95.
- Richardson DK. Vascular Access Nursing – Practice, standards of care and strategies to prevent infection: a
review of flushing solutions and injection caps. Journal of the Association of Vascular Access 2007;12(2):74-84.
- Mermel LA. Prevention of intravascular catheter-related infections. Ann Intern Med 2000;132(5):391-402.
- Patel BM, Dauenhauer CJ, Rady MY, et al. Impact of peripherally inserted central catheters on catheterrelated bloodstream infections in the intensive care unit. J Patient Safety 2007;3:142-48.
- Mermel LA, Farr BM, Sherertz RJ, et al. Guidelines for the management of intravascular catheter-related
infections. Clin Infect Dis 2001;32(9):1249-72.
- Crinch CJ, Maki DG. The promise of novel technology for the prevention of intrvascular device-related
bloodstream infection 1. Pathogenesis and short- term devices. Healthcare Epidemiology 2002:34:1232-42.
- O‘Grady NP, Alexander M, Dellinger EP, et al. Guidelines for the prevention of intravascular catheter-related
infections. Centers for Disease.
Notes:
34 | 35
The Use of Chlorhexidine Gluconate (CHG) on Central
Line Insertion Sites: Disk versus Gel Pad Dressing
Susanne Meninger RN, BSN, Floating Hospital for Children at Tufts Medical Center, et al.
The Use of Chlorhexidine Gluconate (CHG) on Central Line Insertion Sites: Disk versus Gel
Pad Dressing. Poster at the conference of the Association for Vascular Access, September 2009
™
Nurses Rate Tegaderm CHG Dressings
as Easy to Apply and Use
Purpose
The purpose of this document is to describe a product
evaluation conducted by the Floating Hospital for Children
at Tufts Medical Center that compares Tegaderm CHG
Dressings with that of BIOPATCH .
™
100%
Registered nurses on the pediatric medicalsurgical and pediatric bone marrow transplant
unit were surveyed 4 months after the switch
®
from BIOPATCH to Tegaderm™ CHG Dressings.
100%
80%
60%
40%
®
20%
8%
0%
Key Points
“It’s almost
impossible
to put the
Tegaderm™
CHG Dressings
on incorrectly.”
 After two years of using BIOPATCH , the
Floating Hospital for Children at Tufts
Medical Center switched to Tegaderm CHG
Dressings. They were having problems as a
result of the difficulty of applying BIOPATCH .
TEGADERM™ CHG
DRESSING
BIOPATCH ®
How often nurses
reported that
they were always
able to place the
product at the site
per manufacturer
recommendations
®
™
100%
®
92%
80%
 Nurses rated Tegaderm CHG Dressings as
significantly better than BIOPATCH for ease
of application and use. When surveyed,
100% of nurses reported that Tegaderm
CHG Dressings were easy to apply at the
insertion site.
Registered nurses on the pediatric
medical-surgical and pediatric bone marrow
transplant unit were surveyed 4 months after
the switch from BIOPATCH® to Tegaderm™
CHG Dressings.
™
®
™
60%
40%
20%
0%
0%
TEGADERM™ CHG
DRESSING
BIOPATCH ®
How often
nurses reported
they found the
product applied
incorrectly more
than once
36 | 37
Product Evaluation Overview
Key Points (continued)
This product evaluation assessed the clinical performance of Tegaderm™ CHG
Dressings versus BIOPATCH . Twenty Registered Nurses on the pediatric medical®
“Significant cost
savings can be
realized because
Tegaderm CHG
Dressings are
intuitive to apply
and easy to use.”
™
 One nurse participating in the evaluation
commented, “It’s almost impossible to put the
gel pad dressing on incorrectly.”
 Because of expensive training costs, this
hospital recommends that “ease of use” be
a significant factor in product selection for
nursing functions. Significant cost savings
can be realized because Tegaderm CHG
Dressings are intuitive to apply and easy to
use, requiring less training.
surgical and pediatric bone marrow transplant unit were surveyed four months after
the switch from BIOPATCH to Tegaderm™ CHG Dressings. Nurses were excluded from
®
the survey if they did not have experience with both the CHG disk plus cover dressing
and the integrated CHG gel pad dressings.
There were 1,671 BIOPATCH line days from January through September 2008. There
®
were 1,079 Tegaderm™ CHG Dressing line days from October 2008 through May 2009.
Nurses Strongly Prefer Tegaderm CHG
Dressings over BIOPATCH
™
™
®
Nurses rated Tegaderm™ CHG Dressings as significantly better than BIOPATCH for
®
ease of use and application. The survey revealed:
• Dressing placement: 100% of nurses reported they were ALWAYS able to place the
Tegaderm™ CHG Dressings correctly according to manufacturer’s recommendations.
Only 8% of nurses reported they were ALWAYS able to place BIOPATCH correctly.
®
• Dressing application: 100% of nurses reported that the Tegaderm™ CHG Dressings
Hospital Conducts Product Evaluation to Reduce
CR-BSIs and Costs
were easy to apply at the insertion site. Only 15% reported that BIOPATCH were
®
easy to apply.
• Dressing removal: 70% of nurses reported that the Tegaderm™ CHG Dressings
The Floating Hospital for Children at Tufts Medical Center evaluated Tegaderm™ CHG
were easy to remove during a dressing change. Only 8% reported that BIOPATCH
Dressings with the goal of reducing catheter-related bloodstream infections (CR-BSIs)*.
were easy to remove.
In 2006, the hospital started using BIOPATCH to reduce infections. Hospital staff found
®
®
• Incorrect application: 100% of nurses reported they NEVER found Tegaderm™
that they frequently needed to re-educate nurses about how to use BIOPATCH . They
CHG Dressings applied incorrectly. Whereas, 92% of nurses reported they found
also spent a lot of time strategizing on how to best fit and place BIOPATCH on some
BIOPATCH applied incorrectly more than once.
®
®
®
of the catheter lines. For this hospital, the cost of one hour of education for a staff of
Because of expensive training costs, this hospital recommends that “ease of use” be
1,000 nurses is $45,000+, making re-education on BIOPATCH very expensive.
a significant factor in product selection for nursing functions. Significant cost savings
®
can be realized because Tegaderm™ CHG Dressings are intuitive to apply and easy to
In 2008, the hospital switched to Tegaderm™ CHG Dressings. After the switch, nurses
commented about Tegaderm™ CHG Dressings’ ease of use. They also reported
problems with BIOPATCH that were not logged during the time they were using it.
®
These comments prompted this product evaluation.
use, requiring less training.
38 | 39
Evaluation of Tegaderm CHG Dressings for Catheter Care
™
Cindy Zehrer, RN, MS, 3M Health Care, et al.
100%
™
Tegaderm CHG Dressings Preferred
Over BIOPATCH
96%
90%
®
Purpose
The purpose of this product evaluation was to compare
the performance of Tegaderm CHG Dressings versus
BIOPATCH .
™
®
percentage of responses
80%
70%
96% of clinicians rated Tegaderm™ CHG
Dressing the same as, better, or much
®
better than BIOPATCH for intuitive use to
ensure corrrect application. 321 clinicians
at 16 hospitals participated in this product
evaluation.
60%
Intuitive to
use and apply
correctly
50%
40%
30%
20%
10%
4%
0%
Key Points
8
 Skilled IV nurses, who were using BIOPATCH
and transparent adhesive cover dressings
evaluated Tegaderm CHG Dressings during
in-patient hospital evaluations.
same as, better
or much better
®
™
 These nurses preferred Tegaderm CHG
Dressings over BIOPATCH in the evaluations.
100%
80%
™
®
 Tegaderm CHG Dressings work well in
specialty units, including MICU, SICU, ICU,
CCU, oncology, transplant, respiratory and
cardiac.
™
95,1%
90%
percentage of responses
CR-BSIs extend
hospital stays
by 20 days .
much worse
or worse
70%
95,1% of clinicians rated Tegaderm™ CHG
Dressing the same as, better, or much better
®
than BIOPATCH for ability to visualize the IV
site through the CHG gel pad. 321 clinicians
at 16 hospitals participated in this product
evaluation.
60%
Able to visually
monitor the IV
site through the
CHG gel pad
50%
40%
30%
20%
10%
4,9%
0%
much worse
or worse
same as, better
or much better
40 | 41
Risk Factor for Catheter Related Bloodstream
Infections (CR-BSIs) from Skin Organisms
The dressings were evaluated in various medical and surgical specialty areas,
Organisms on the patient’s own skin, at the catheter insertion site, are considered a
• Surgical Intensive Care Unit (SICU)
major risk factor for CR-BSIs.1 Among the strategies found to be successful in reducing
• Intensive Care Unit (ICU)
CR-BSIs is the use of products containing chlorhexidine gluconate (CHG). CHG has
• Coronary/Cardiac Care Unit (CCU)
been used as a skin antiseptic since 1950. Its effectiveness and safety has been well
• Oncology
documented.1,2
• Transplant (solid organ and bone marrow)
including:
• Medical Intensive Care Unit (MICU)
• Respiratory
• Cardiac
CHG Skin Prep versus CHG Dressings
™
Tegaderm CHG
Dressings are
preferrred by
clinicians over
BIOPATCH
®
While the use of CHG as a skin prep is an effective antiseptic technique for temporary
reduction of skin organisms, the CHG becomes inactive over time allowing skin
organisms to regrow under the dressing. Tegaderm™ CHG Dressings and BIOPATCH
3
Tegaderm CHG Dressing Outperforms
BIOPATCH in All Factors
™
®
®
maintain low skin organism counts beyond 48 hours prolonging the antimicrobial
Tegaderm™ CHG Dressings were rated on average “same as”, “better”, or “much
activity of the CHG skin prep.
better” than BIOPATCH plus transparent adhesive cover dressings in all of the specific
®
performance factors, including:
Both provide the following benefits based on in vivo and in vitro testing:
4-6
• Kills skin flora
• Ease of use
• Ability to visualize the IV site
• Suppresses regrowth of skin organisms
• Ability to absorb fluid
• Provides broad-spectrum activity
• Overall dressing adherence and wear time
• Offers long term antimicrobial activity (tested up to 10 days)
• Continues to be effective in the presence of blood, saline and exudate
• Time required to apply dressing
• Ease of applying dressing over IV site
• Ability of the CHG gel pad to mold and conform around the catheter
• Ease of removal
Product Evaluation Overview
Tegaderm™ CHG Dressings worked well in a variety of specialty units on patients with
challenging medical conditions.
Skilled IV nurses, who were using BIOPATCH , evaluated Tegaderm™ CHG Dressings
®
during in-patient hospital evaluations.
The study was conducted as follows:
Advantages of a Single Integrated CHG Dressing
• 16 hospitals across the United States were selected for participation based on their
current use of BIOPATCH .
®
Tegaderm™ CHG Dressings allowed for intuitive application with little training because
• 321 clinicians participated in this product evaluation.
they are similar to dressings subjects had been using already. Because it is a single,
• More than 500 Tegaderm™ CHG Dressings were applied during the evaluation
integrated dressing, the Tegaderm™ CHG Dressing eliminates one product in the CVC
period. Clinicians used only the Tegaderm™ CHG Dressings during the evaluation.
• Nurses were provided training to use Tegaderm™ CHG Dressings in place of
BIOPATCH .
®
dressing change process. Therefore, the process is simplified and opportunities for
error are eliminated. When a patient has a central line, nursing practice includes
monitoring of the insertion site. The ability to see the IV insertion site was not possible
with use of the BIOPATCH . With Tegaderm™ CHG Dressings, nurses were able to
®
visualize the insertion site for complications of infusion therapy. Visual inspection of
the insertion site is best practice according to published guidelines from the CDC and
Infusion Nursing Standards of Practice.
1,7
42 | 43
Notes:
321 clinicians at the following 16 hospitals participated in this product evaluation.
Table 1: Participating hospitals and number of evaluators
FACILITY NAME
LOCATION
NUMBER (%)
OF EVALUATORS
17 (5.3%)
Indiana University Hospital
Indianapolis, IN
Banner Thunderbird MC
Glendale, AZ
Providence Portland MC
Portland, OR
6 (1.9%)
Providence St. Vincent MC
Portland, OR
11 (3.4%)
Duke University Hospital
Durham, NC
22 (6.8%)
Sentara Virginia Beach
General Hospital
Johns Hopkins Hospital
Virginia Beach, VA
17 (5.3%)
Baltimore, MD
12 (3.7%)
Hackensack Hospital
Hackensack, NJ
14 (4.4%)
Scott and White
Memorial Hospital
Temple, TX
2 (0.6%)
Porter Adventist Hospital
Denver, CO
24 (7.5%)
LAC+USC Medical Center
Los Angeles, CA
9 (2.8%)
9 (2.8%)
St. Joseph's Hospital
Tampa, FL
29 (9.0%)
Baptist Memorial Hospital
Memphis, TN
21 (6.5%)
Intermountain Health Care
Salt Lake City, UT
Dartmouth-Hitchcock
Medical Center
Lebanon, NH
19 (5.9%)
St. David’s S. Austin Hospital
Austin, TX
16 (5.0%)
93 (29.0%)
Referenced Articles
1. Centers for Disease Control and Prevention. Guidelines for the prevention of intravascular catheter-related
infections. MMWR. 2002;51(RR-10):1-29.
2. Marschall et al (2008). Strategies to Prevent Central Line–Associated Bloodstream Infections in Acute
Care Hospitals ICHE. Vol 29; Suppl 1 S22-S30.
3. Denton, GW: Chlorhexidine. In Disinfection, Sterilization and Preservation. ed. Seymour S. Block. Lippincot
Williams & Wilkins, Philadelphia, PA, 2001;321-336.
4. Maki, DG (2008). A Novel Integrated Chlorhexidine-Impregnated Transparent Dressing for Prevention of
Vascular Catheter-related Bloodstream Infection: A Prospective Comparative Study In Healthy Volunteers.
SHEA, April 2008.
5. Bashir, MH (2008). Suppression of Regrowth of Normal Skin Flora under Chlorhexidine Gluconate
Dressings Applied to CHG-Prepped Skin. ICAAC/IDSA, Oct 2008.
6. Data on file.
7. Infusion Nursing Standards of Practice. J Infus Nurs. 2006;29(1 Suppl):S1-92.
8. Dimick JB, et al (2001). Increased resource use associated with catheter-related bloodstream infection in
the surgical intensive care unit. Arch Surg;136:229–34.
44 | 45
Prospective, Randomized, Controlled Trial Assessing the Clinical
Performance of a Transparent Chlorhexidine Gel Pad Intravascular
Catheter Dressing
Dr. Mark Rupp, University of Nebraska Medical Center, et al.
Poster at the conference of the Society for Health Care Epidemiology of America, April 2008.
™
Tegaderm CHG Dressings Are Potentially
an Innovative Solution for CR-BSIs
*
Purpose
The purpose of this study was to assess the clinical
performance of Tegaderm CHG Dressings in
comparison to IV 3000 standard transparent dressings.
3M Tegaderm CHG Dressings come
in multiple sizes and shapes for a variety of
catheter sites (photos showing subclavian site,
internal jugular, peripherally inserted central
catheter and arterial line).
Not intended to replace sutures on nontunneled catheters.
™
™
™
™
Rated superior
compared to
IV 3000
in catheter
securement
and overall
satisfaction
™
Key Points
CR-BSIs are
a significant
medical problem.
Novel approaches
are needed to
prevent CR-BSIs.
 Tegaderm CHG Dressings provide an innovative method to minimize potentially CR-BSI.
™
 Tegaderm CHG Dressings outperformed
IV 3000 dressings with regard to catheter
securement and overall satisfaction.
™
™
46 | 47
Study Examines the Clinical Performance of
Tegaderm CHG Dressings
This study was performed to assess the clinical performance of Tegaderm™ CHG
care center) was the site for this study. 60 subjects participated in the
Dressings, which are designed to minimize the growth of microbes at the catheter
study. They were stratified by catheter insertion site: 20 internal jugular;
insertion site. The study also compared the performance of Tegaderm™ CHG Dressings
20 subclavian or femoral; and 20 antecubital PICC.
™
versus a comparator dressing.
™
Tegaderm
CHG Dressings
outperformed
the competitor
dressing
with regard
to catheter
securement
and overall
satifsaction.
The study was a prospective, controlled, randomized, clinical trial comparing
Tegaderm™ CHG Dressings to IV 3000™ (Smith & Nephew, London, UK), a
standard transparent dressing. The study was conducted at the Nebraska
Medical Center as follows:
• Study personnel applied the study dressings per manufacturer’s recommendations.
• The dressings were evaluated daily for adherence (edge lift), catheter securement
(catheter migration), transparency, skin condition (erythema/edema), presence of
moisture or blood and patient comfort.
• At the time of dressing removal, the reason for removal was noted as well as ease of
removal, presence of dressing residue and skin condition (maceration, skin stripping,
erythema, edema).
• At day 7/patient discharge/catheter removal, an assessment of overall clinician
satisfaction was performed.
• At day 7, a microbiologic assessment was performed. For subjects with 7 days of
continuous study dressing wear, a swab culture of 10 cm of skin at the catheter
2
insertion site was performed.
™
Tegaderm CHG Dressings Rated Superior
Compared to IV 3000 in Catheter Securement
and Overall Satisfaction
™
The Tegaderm™ CHG Dressings outperformed the IV 3000™ dressings in:
• Catheter securement
• Overall satisfaction
There were no significant differences between the groups with regard to ease of
dressing application, dressing edge lift, ability to visualize the catheter insertion site,
skin condition at insertion site (erythema, edema, maceration, skin stripping, moisture),
blood under the dressing, ease of, removal or patient assessment of discomfort.
The Nebraska Medical Center (a 689 bed, university-associated, tertiary
48 | 49
CLINICAL EFFECTIVENESS
Gluconate Transparent IV Securement Dressing
Patricia Gould, RN and Antje Oudakker, RN
St. Joseph’s Mercy Health Center, Hot Springs, AR
Poster at the fifth Decennial International Conference on Healthcare-Associated Infections, 2010
By Using Tegaderm CHG an ICU
Reported ZERO CLABSIs in 2009
Objective
Objective was to save lives, decrease cost and length
of stay by reducing the number of CLABSIs to zero and
sustaining the zero rate in the critical care unit.
Standard
Transparent
Dressing
(Mean=3.1)
Silver
patch
(Mean=2.5)
CHG
Securement
Dressing
(Mean=0.0)
Conclusion
The goal of
reaching zero
is achievable.
 The results of the time period studied
suggests that the use of a Chlorhexidine
Gluconate Transparent IV Securement
Dressing* and bundle practices, reduces
the risk of bloodstream infections as well
as saves lives, decreases length of stay and
reduces costs associated with infections.
Infection Rates
per Thousand
Catheter Days
50 | 51
Background
Results
Despite compliance with evidence based guidelines and “bundles” for the prevention
• The goal of reaching ZERO was accomplished!
of Central Line-Associated Bloodstream Infections (CLABSIs), the CLABSI rate in the
critical care unit at St. Joseph’s Mercy Health Center was 4.08/1,000 central line
• The rate of ZERO CLABSIs was sustained for the 9 month period of time and remains
days for the 12 months prior to study (Sept 07 – Sept 08). Prior dressings included a
transparent dressing with or without a silver alginate IV
at ZERO presently.
patch†.
• Compliance with Chlorhexidine Gluconate Transparent IV Securement Dressing*
9 months using
Tegaderm CHG
on a total of 6011
central line days
without CLABSI.
Saving lives,
reducing lenght
of stay and
saving costs
substantially.
was 100%.
Methods
• Staff and Physicians satisfaction with dressing played an important role in
compliance.
• All patients with central lines over the 9 month period included in the study.
• The NHSN/CDC1 definition of CLABSI was used to determine CLABSI.
• No adverse reactions reported.
• Dressing change protocol of using Chlorhexidine Gluconate Transparent IV
Securement Dressing* and changing every Sunday or when it became loose
• Based on a 2-rate chi-square test, the rates of infections significantly decreased
or soiled was implemented January 1, 2009.
from the standard transparent dressing to seperate (a mean of 3.1 infections per
• Compliance was monitored daily by charge nurse when rounding to count line days.
1,000 central line days) to the Chlorhexidine Gluconate Transparent IV Securement
Dressing* (a mean of 0 infections per 1,000 central line days, p<0.001). The 2-rate
chi-square test assumes that infection counts follow a Poisson distribution.
• Based on data published in On the CUSP: Stop BSI Central Line-Associated
Bloodstream Infection Toolkit2:
– The average attributable mortality related to CLABSI is 18% (0-35%).
– The length of stay associated with CLABSI on average is increased
by 13 hospital days.
– The cost of each CLABSI is $45,254.
– Based on the hospital’s CLABSI rate of 4.08/1,000 days prior to the implementation
of the Chlorhexidine Gluconate Transparent IV Securement Dressing*:
– A potential of 4 patient deaths were prevented.
– A potential of 286 avoidable days were prevented.
– There was an estimated cost savings of $989,516.55 per year.
1
CDC/NHSN surveillance definition of healthcare associated infection and criteria for specific types of
infection in the acute care setting; Am J Infect Control 2008; 36-309-32
®
† DeRoyal Algidex Ag IV Patch Silver Alginate Catheter Dressing
™
* 3M Tegaderm CHG Chlorhexidine Gluconate IV Securement Dressing
™
™
52 | 53
Strategies to Eliminate Catheter-Related Bloodstream Infections
Peggy Pappas, RN, BSN, Director; Susan Schillace, RN Lead PICC Nurse
Timothy Creamer, Janet Draughon, Barbara Warren Regional Medical Center Bayonet Point, Hudson, Florida
Poster at the conference of the Association for Vascular Access, September 2009.
ZERO CR-BSI Maintained During
3 Consecutive Quarters
Objective
Achieving a rate of zero CR-BSI was the goal of the
committee members.
Conclusions
 A multidisciplinary approach, along with
established standards, ongoing education
and literature research were imperative to
achieving our objective of lowering CR-BSI
rates.
Tegaderm CHG
is a valuable
element added
to care-bundles to
reduce CR-BSIs
 We recommend the CHG gel pad dressing as
part of our bundle to reduce CR-BSIs.
2
 Our next objective is to integrate the 2010
National Patient Safety Goals to improve
outcomes.
2
3M Tegaderm CHG Chlorhexidine Gluconate IV Securement Dressing
™
™
* Peripheral inserted central catheters
PICC BSI Rates
2007-2009
54 | 55
Background
Regional Medical Center Bayonet Point is a 293 bed acute care hospital. Between
2006 and 2007 we experienced a steady increase in our catheter-related bloodstream
infection (CR-BSI) rates. By the end of 2007, our CR-BSI rate climbed to 3.4 per 1000
patient days. A formal committee convened to research and formulate strategies to
decrease CR-BSI.
High
performance
antimicrobial
dressings
have a role to
play where the
infection rates are
persistantly high.
Materials and Methods
The Intravascular Team implemented a practice change (in 1st and 2nd Quarter 2008)
including the following:
• PICC Team oversees dressing changes and monitors integrity and performance of all
central lines.
• Changed from luer-access mechanical valve with positive displacement to neutral
displacement valve.
• Improved insertion technique and site selection.
• Improved surveillance: Appropriateness of placement and discontinuation of central
lines.
• Staff Education: Skills lab, orientation and real time at bedside with patients and
bedside nurse.
• Changed dressing from silver patch1 to CHG gel pad dressing2.
• Revised policy to reflect the changes related to insertion, maintenance and use of
central lines.
Results
By the 2nd Quarter 2008, our CR-BSI rate dropped to 0 and was maintained until 2nd Q
2009, when our rate increased to 0.5/1000. Between 2/08 and 6/09 we have had two
CR-BSIs.
1
DeRoyal Algidex Ag IV Patch Silver Alginate Catheter Dressing
2
3M Tegaderm CHG Chlorhexidine Gluconate IV Securement Dressing
®
™
™
™
Notes:
56 | 57
Effect of Chlorhexidine Gluconate (CHG) Gel Dressing on Adult Central
Venous Line-Related Primary Bloodstream infections
Mary Reilly RN, BSN, St. Vincent Mercy Medical Center, Toledo, Ohio
Poster at the conference of the Association for Vascular Access, September 2009.
The Adoption of Tegaderm CHG Resulted
in a One-Third Reduction of CR-BSI Risk
Objectives
To determine whether a chlorhexidine gluconate (CHG)
gel dressing† could decrease the rate of primary catheter
related bloodstream infections (CR-BSI).
Conclusions
The CR-BSI
rate was still
2.2 / 1000
c.d. in spite of
implementing
CDC guidelines
and using a CHG
sponge.
 The focused intervention of introducing a one
step CHG gel occlusive dressing to central
line sites resulted in a dramatic decrease in
CR-BSI.
 Staff recommended this dressing† over
the previous CHG sponge* and dressing as
there was less room for error in applying
the dressing and that the dressing stayed
in place for the whole seven days even on
jugular sites.
®
* Ethicon, Inc. Biopatch Antimicrobial Disc
† 3M™ Tegaderm CHG Chlorhexidine Gluconate IV Securement Dressing
™
Red lines represent upper and lower statistical
control limits. Green lines represent the mean
rate; showing a change from 2.2 / 1000
catheter days to 0.7 per 1000 catheter days.
CR-BSI rates
(ICU and Non-ICU
combined)
CR-BSI rate
(Non-ICU only)
CR-BSI rates
(ICU only)
58 | 59
Background
Results summary
Central lines are used in multiple settings such as ICU and general floors throughout
Prior to implementation of the CHG gel dressing† the infection rate (standard error, SE)
the hospital to provide vascular access. The cost of a central line-associated
was 2.15 (0.40) infections per 1000 catheter days. After implementation of the CHG
1
There are
situations where
a full compliance
to the guideline is
still not enough ...
The intuitive
transparent
Tegaderm
CHG Dressing
contributes to
further reduce
the CR-BSI rate.
bloodstream infection (CLABSI) can range from $3,700 to $29,000 per episode .
gel dressing† the infection rate decreased significantly (p<0.002) to anestimated rate
The reduction of CLABSIs is important to decrease the patient’s risk of morbidity and
(SE) of 0.66 (0.23) infections per 1000 catheter days. The relative risk (RR) of a CRBSI
mortality as well as decrease the patient’s hospital stay. In 2007, the CLABSI goal
after implementation of the CHG gel dressing† was estimated to be 0.3066. That is,
for our facility was to remain below the median National Healthcare Safety Network
the risk of a CR-BSI was 0.3066 times (roughly one-third) the risk of infection with the
(NHSN) rate of 2.1/1000 device days. We implemented the CDC Guidelines for the
CHG sponge*. The 95% CI of theRR was (0.140, 0.671).
Prevention of Intravascular Catheter-Related Infection practices and utilized a CHG
impregnated sponge*. In 2008, CLABSI education was completed and a review
of the current CHG sponge* application was performed. The six-month and nine-month
rate for CLABSI was 2.2. Audits of the central line dressings revealed that
Conclusions
CHG sponges* were incorrectly placed 40 percent of the time. The units were
re-educated and practice pointers were sent out, initially improving compliance
but over time incorrect sponge* placement still remained a factor.
The focused intervention of introducing a one step CHG gel occlusive dressing† to
central line sites resulted in a dramatic decrease in CLABSI.
Staff recommended this dressing† over the previous CHG sponge* and dressing as
there was less room for error in applying the dressing and that the dressing stayed in
place for the whole seven days even on jugular sites.
Objective
To determine whether a chlorhexidine gluconate (CHG) gel dressing† could decrease
the rate of primary central line-related bloodstream infections (CLABSI).
1
Marschall J, Mermel L, Classen D, et al. A Compendium of Strategies to Prevent Central Line-Associated
Bloodstream Infections in Acute Care Hospitals. Infect Control and Hosp Epidemiol. 2008; 29: S22-S30.
* Ethicon, Inc. Biopatch Antimicrobial Disc
† 3M Tegaderm CHG Chlorhexidine Gluconate IV Securement Dressing
®
™
Materials and Methods
The study was conducted in a 544 bed, critical care regional teaching center on the
adult ICU and non-ICU patient units. Infection rates were calculated each month by
number of primary central line-associated blood stream infections (CLABSI) per total
device days x 1000. The CLABSI rates were plotted by month for the period of time
prior to the change in practice and for the period of time after the change using a
U-chart (control chart). The multidisciplinary Infection Control Committee approved a
trial of CHG gel dressings† with a complete product switch-out on the adult units in
October 2008. Education regarding the use of the CHG gel dressing† was completed
through walking in-services and practice pointers. The same CVL policies were
maintained except that dressing changes were now once a week. In October 2008, the
central line CHG sponge* change kits were removed and the new CHG gel dressing†
change kits were implemented with unit education.
™
60 | 61
HEALTH ECONOMICS
Economic Evaluation of Antimicrobial IV Dressings
Jonathan Brenner, MBA, 3M Health Care.
$7
™
Tegaderm CHG Dressings Have the
Potential to Reduce Hospital Costs
The cost to
the hospital of
treating infections
is between 90
and 400 times
the cost of labor &
dressings
$6
Purpose
The purpose of this document is to describe a review of
relevant literature, followed by nationwide surveys of U.S.
nurses, physicians and hospital administrators, to identify
and evaluate labor and materials associated with the
application of IV dressings and with the costs of treating
local infections and CR-BSIs.
$ Millions
$5
$4
$3
$2
$1
$0
Training
Dressing Labor
Tegaderm TM
CHG Dressing
Dressing
Product
BIOPATCH®
Local Infection
CR-BSI
Transparent dressing only
Key Points
®
 The budget impact of CVC dressings on
hospitals extends far beyond dressing price.
Other costs include prevention, detection
and control of complications (local infection
and CR-BSI) and the downstream costs of
reimbursement and public disclosure.
 The economic model suggests that Tegaderm
CHG dressings can minimize health care costs by
– reducing the costs associated with the
misapplication of BIOPATCH
– reducing the infection rate accuring when
using transparent dressings alone
™
®
* National nurse survey
CVC DRESSING
TOTAL COST OF CARE
Tegaderm™ CHG Dressing
$ 3.068,681
BIOPATCH®
$ 3.592,524
Transparent dressing only
$ 6.283,706
Projected
budget impact
at hypothetical
hospital is lowest
with Tegaderm
CHG dressing
™
Health Economics
68% of
BIOPATCH
applications
were reported
as incorrect in
clinical practice.*
62 | 63
HEALTH ECONOMICS
Economic Evaluation Overview
The financial impact of caring for hospitalized patients with central venous catheters
(CVCs) encompasses a range of costs, including CVC dressings, nursing labor time and
treatment of any local infections and catheter related bloodstream infections (CR-BSIs).
CR-BSIs represent notable clinical, mortality and economic risks for hospitals, with the
estimated cost for treating a single CR-BSI exceeding $80,000.1-6 The annual total U.S.
hospital cost of CR-BSIs exceeds $9 billion.
®
In the national nurse survey, nurses reported receiving longer training for BIOPATCH® than for
Tegaderm™ CHG Dressings. Even with this additional training, survey results show rates of dressing
misapplication were significantly higher for BIOPATCH®:
• In the national nurse survey, 68% of BIOPATCH applications were reported as incorrect in clinical practice.
®
7
™
Tegaderm CHG
Dressings may
reduce costs
associated with
misapplication
of BIOPATCH .
®
BIOPATCH Application Errors Persist with
Additional Training
Previous studies have shown that the incidence of CR-BSIs and local infections are
lower for chlorhexidine gluconate (CHG)-impregnated dressings than for dressings
• In Eyberg’s study of 12 IV nurses, 25% of BIOPATCH were incorrectly applied immediately after training.15
®
The model used in this study conservatively used an application error rate of 25% for BIOPATCH®,
although the actual error rate could be significantly higher as the survey results suggest.
without CHG.8-12 In this study, standard transparent dressings, Tegaderm™ CHG
Dressings and BIOPATCH were evaluated in a health economic model to assess the
®
economic and clinical impact of using each. The expected cost per patient for each
product was calculated and weighed against the likelihood of occurrence. The total
Conclusion
cost to hospitals for using each dressing was analyzed.
The model suggests that Tegaderm™ CHG Dressing could minimize healthcare costs by reducing the costs associated
with the misapplication of BIOPATCH and the use of transparent dressing alone. Tegaderm™ CHG Dressing is projected to
®
This economic evaluation was conducted as follows:
• A review of relevant literature was conducted.
• U.S. nurses, physicians, and hospital administrators were surveyed to identify and
evaluate the labor and materials associated with dressing application and the costs
have important implications for clinical and economic outcomes due to its ease of use and intuitive application. Effectively
managing the total cost of care should be a significant consideration for clinicians and hospitals in the context of caring for
CVC patients.
of treating local infections and CR-BSIs.
• Fifty nurses who care for CVC patients participated in an in-depth survey of real-life
clinical practices.13
Referenced Articles
Dressing Application Errors Increase Costs to
Hospitals
In this health economic model, dressing application errors were found to have
substantial implications for the total cost of care for CVC patients. CVC dressings, when
applied correctly, incurred ordinary labor and material costs. When applied incorrectly,
the errors result in higher rates of local infection and/or CR-BSI.
The economic burden of diagnosing and treating a local infection is relatively modest
compared to the high cost of treating a CR-BSI. The financial burden to hospitals of
diagnosing and treating these patients rapidly escalates with higher rates of dressing
application errors. Additionally, the cost to treat these infections is found to be
drastically higher than the cost of labor and dressings.
1. Dimick JB, Pelz RK, Consunji R, Swoboda SM, Hendrix CW, Lipsett PA. Increased resource use associated with catheter-related bloodstream infection
in the surgical intensive care unit. Arch Surg. 2001; Feb;136(2):229–34.
2. Pittet D, Tarara D, Wenzel RP. Nosocomial bloodstream infection in critically ill patients. Excess length of stay, extra costs and attributable mortality.
JAMA. 1994 May 25; 271(20):1598–601.
3. Bureau of Labor Statistics (http://www.bls.gov/data/), Accessed January 2009.
4. Centers for Disease Control and Prevention. Guidelines for the prevention of intravascular catheter-related infections. MMWR. 2002;51(RR-10):1-26.
5. FDA Prescribing Information (drugs.com), Merck Manual (http://www.merck.com/mmpe/sec10/ch119/ch119b.html),
Johns Hopkins POC-IT Center ABX Guide (http://prod.hopkins-abxguide.org/antibiotics/antibacterial/penicillinaseresistant_pcn/nafcillin.html?
contentInstanceId=254860), accessed November 2008.
6. Stevens D, Bisno A, Chambers H, Everett E, Dellinger P, Goldstein E, Gorbach S, Hirschmann J, Kaplan E, Montoya J, Wade J, Infectious Diseases
Society of America. Practice guidelines for the diagnosis and management of skin and soft-tissue infections. Clin Infect Dis. 2005;
Nov 15;41(10):1373–406.
7. U.S. Department of Health and Human Services. HHS Action Plan to Prevent Health Care-Associated Infections, 2009.
8. Chambers ST, Sanders J, Patton WN, Ganly P, Birch M, Crump JA, Spearing RL. Reduction of exit-site infections of tunnelled intravascular catheters
among neutropenic patients by sustained-release chlorhexidine dressings: results from a prospective randomized controlled trial.
J Hosp Infect. 2005 Sep;61(1):53-61.
9. Hanazaki K, Shingu K, Adachi W, Miyazaki T, Amano J. Chlorhexidine dressing for reduction in microbial colonization of the skin with central venous
catheters: a prospective randomized controlled trial. J Hosp Infect. 1999 Jun;42(2): 165-8.
10. Maki, DG, Mermel L, Genthner D, Hua S, Chiacchierini RP. An evaluation of BIOPATCH Antimicrobial Dressing compared to routine standard of care in
the prevention of catheter-related blood stream infection. Johnson and Johnson Medical Division of ETHICON, Inc. 2000.
11. Roberts B, Cheung D. BIOPATCH-a new concept in antimicrobial dressings for invasive devices. Aust Crit Care. 1998 Mar;11(1): 16-9.
12. Ruschulte H, Franke M, Hertenstein B, Mahr KH, Hecker H, Gastmeier P. Anti-infective wound dressing reduces catheter-related infections in oncological
patients. Poster abstract presented at Euroanaesthesia 2006, the European Society of Anaesthesiology’s Annual Meeting in Madrid,
Spain June 3-6, 2006.
13. Quintiles Survey Results, December 2008, (Data on File with 3M).
14. Siegman-Igra Y, Anglim AM, Shapiro DE, Adal KA, StrainBA, Farr BM.Diagnosis of Vascular Catheter-Related Bloodstream Infection: a Meta-Analysis”
J Clin Microbiol. 1997 Apr;35(4):928-36.
15. Eyberg C, Pyrek J. A Controlled Randomized Prospective Comparative Study to Evaluate the Ease of Use of a Transparent Chlorhexidine Impregnated
Gel Dressing Versus A Chlorhexidine Disk in Healthy Volunteers. Journal of the Association for Vascular Access (JAVA). Fall 2008; Vol 13 No. 3 112-117.
64 | 65
HEALTH ECONOMICS
Notes:
Product
Information
PRODUCT INFORMATION
66 | 67
PRODUCT INFORMATION
™
Application and Removal Guide
Tegaderm CHG with innovative gel pad
Provides a reservoir for consistent and continuous
antimicrobial action over time.
COMPOSITION OF TEGADERM™ CHG GEL PAD
Gel Pad
composition
Application
1
2
3
POLYMER
1. Open the package and remove the sterile
Tegaderm™ CHG dressing. Peel the liner from
the dressing, exposing the adhesive surface.
Flip over the dressing so the adhesive faces
the skin. Do not stretch the dressing.
2. Center the CHG gel pad over the catheter site
and smooth down the dressing edge. On sutured
catheters, the gel pad can be placed over both
insertion and suture sites. Device should be
stabilized according to facility protocol.
3. Slowly remove the paper frame while
continuing to smooth down the outer edges
of the transparent adhesive dressing.
POLYPOL
WATER
5
4
1658R
5
1657R & 1659R
6
CHG
Available Sizes
4. Smooth the Tegaderm™ CHG dressing from
the center toward the edges, using firm
pressure to enhance adhesion.
1657R
1658R
1659R
8.5 cm x 11.5 cm
10 cm x 12 cm
10 cm x 15.5 cm
(Gel Pad: 3 cm x 4 cm)
5. Apply the tape strips to secure the catheter,
one under the tubing and the other one over
the tubing. Tegaderm™ CHG 1658R includes
only one tape strip that is placed under the
tubing and over the dressing edge to secure
the catheter
6. On the label, document dressing change
information according to your facility protocol.
Place the label on the dressing.
Secure any catheter lumens or extensions.
Low and Slow Removal
1
2
3
The Benefits of a Trusted Tegaderm Dressing
™
For over 25 years the Tegaderm™ brand has stood for trustworthiness, dependability
and innovation. The specific characteristics of Tegaderm™ provide clinicians with
1. Remove the tape strips used to secure the
tubing.
2. Gently grasp an edge of the Tegaderm™ CHG
dressing and slowly peel the dressing from
the skin, toward the insertion site or in the
direction of hair growth. Keep removal “low
and slow.”
A medical adhesive solvent may be used to
facilitate removal, but is not necessary.
outstanding advantages in catheter securement and infection prevention of IV Sites:
• The semi-permeable polyurethan film permits vapor and oxygen exchange
and provides a barrier to external contaminants including liquids, bacteria and yeast
• The latex-free adhesive ensures the right balance between securely holding
catheters in place and being gentle to the skin
• The transparent dressing enables continuous visual inspection of the catheter site
• The intuitive design allows hassle-free application and minimizes the opportunity
for error
+
®
Photos have been taken with ARROWgard Blue PLUS Central Venous Catheter (Trademark of Arrow Inc.)
3. As the dressing is peeled back, place a thumb
or forefinger on the gel pad to facilitate
removal. Tegaderm™ CHG dressing should be
removed with the gel pad intact. Peel dressing
toward the catheter site, supporting the skin
and catheter to minimize risk of catheter
dislodgement. Do not pull the dressing
straight up from the skin as this can cause
potential skin trauma.
68 | 69
PRODUCT INFORMATION
3M Tegaderm CHG Dressing
™
™
Chlorhexidine Gluconate IV Securement Dressing
Description:
Warnings:
3M™ Tegaderm™ CHG Dressing, Chlorhexidine Gluconate IV Securement Dressing, is
DO NOT USE TEGADERM™ CHG DRESSINGS ON PREMATURE INFANTS. USE OF
used to cover and protect catheter sites and to secure devices to skin. It is available in
CHLORHEXIDINE GLUCONATE CONTAINING PRODUCTS ON PREMATURE INFANTS MAY
a variety of shapes and sizes.
RESULT IN HYPERSENSITIVITY REACTIONS OR NECROSIS OF THE SKIN.
Tegaderm™ CHG Dressing consists of a transparent adhesive dressing and an
THE SAFETY AND EFFECTIVENESS OF TEGADERM™ CHG DRESSINGS HAS NOT BEEN
integrated gel pad containing 2 % w/w chlorhexidine gluconate (CHG), an antiseptic
EVALUATED IN CHILDREN UNDER 18 YEARS OF AGE. FOR EXTERNAL USE ONLY.
agent with broad spectrum antimicrobial and antifungal activity. The gel pad absorbs
DO NOT ALLOW THIS PRODUCT TO CONTACT EARS, EYES, MOUTH OR MUCOUS
fluid. The transparent film provides an effective barrier against external contamination
MEMBRANES.
including fluids (waterproof), bacteria, viruses* and yeast and protects the IV site.
DO NOT USE THIS PRODUCT ON PATIENTS WITH KNOWN HYPERSENSITIVITY TO
In vitro testing (time kill and zone of inhibition) demonstrates that the Tegaderm™ CHG
CHLORHEXIDINE GLUCONATE. THE USE OF CHLORHEXIDINE GLUCONATE CONTAINING
gel pad has an antimicrobial effect against a variety of gram-positive and gram-
PRODUCTS HAS BEEN REPORTED TO CAUSE IRRITATIONS, SENSITIZATION AND
negative bacteria and yeast, including organisms most commonly associated with
GENERALIZED ALLERGIC REACTIONS. IF ALLERGIC REACTIONS OCCUR, DISCONTINUE
catheter-related bloodstream infections (CR-BSI).
USE IMMEDIATELY AND IF SEVERE, CONTACT A PHYSICIAN.
Tegaderm™ CHG Dressing is transparent, allowing continual site observation and is
Hypersensitivity reactions associated with topical use of chlorhexidine gluconate have
breathable, allowing good moisture vapor exchange.
been reported in several countries. The most serious reactions (including anaphylaxis)
have occurred in patients treated with lubricants containing chlorhexidine gluconate,
* In vitro testing shows that transparent film provides a viral barrier from viruses 27
which were used during urinary tract procedures. Caution should be used when using
nm in diameter or larger while the dressing remains intact without leakage. The barrier
chlorhexidine gluconate containing preparations and the patient should be observed
to viruses is due to the physical properties of the dressing, rather than the ancillary
for the possibility of hypersensitivity reactions.
properties of CHG.
Precautions: 3M™ Tegaderm™ CHG Dressing should not be placed over infected
wounds or on non-healthy skin. It is not intended to be used as a treatment of
Indications:
percutaneous device-related infections or catheter related blood stream infections.
Biocompatibility studies were conducted for dressing use up to 30 days.
3M Tegaderm CHG Dressing, Chlorhexidine Gluconate IV Securement Dressing can
™
™
be used to cover and protect catheter sites and to secure devices to skin. Common
In the case of clinical wound infection, systemic antibacterials should be used if
applications include securing and covering IV catheters, other intravascular catheters
indicated.
and percutaneous devices. Tegaderm™ CHG dressing can be used to reduce skin
colonization and suppress regrowth of microorganisms.
Any active bleeding at the insertion site should be stabilized before applying the
dressing.
Do not stretch the dressing during application. Mechanical skin trauma may result if
the dressing is applied with tension.
The skin should be dry, healthy and free of detergent residue to prevent skin irritation
and to ensure good adhesion. Allow all preps and protectants to dry completely before
applying the dressing to prevent skin irritation and to ensure good adhesion.
70 | 71
PRODUCT INFORMATION
Instructions for Use:
Removal: Gently grasp an edge of the transparent dressing and slowly peel the
dressing from the skin in the direction of hair growth. Avoid skin trauma by peeling the
Dressing Selection: Choose a dressing large enough to provide at least one inch
dressing back, rather than pulling it up from the skin.
margin of adherence on dry, healthy skin around the catheter site.
To facilitate removal of the gel pad, use sterile alcohol wipes or swabs or sterile normal
Site Preparation: Prepare the site according to institution protocol. Clipping of hair
at the site may improve dressing adhesion. Shaving is not recommended. The skin
saline. If needed, a medical adhesive solvent can be used to help remove the dressing
border.
should be clean, dry and free of detergent residue. Allow all preps and protectants to
dry completely before applying the dressing to prevent skin irritation and to ensure
Care should be taken not to dislodge catheters or other devices when the dressing is
good adhesion.
removed. Support the skin and catheter while removing the dressing.
Any active bleeding at the insertion site should be stabilized before applying the
Shelf Life and Storage Information: For best results, store in a cool, dry place.
dressing.
For shelf life, refer to the expiration date on the package. Sterility of the dressing is
guaranteed unless individual package is damaged or open.
Application:
If you have any questions or comments, contact the 3M Health Care Customer Help
1. Open package and remove sterile dressing.
Line at 01509 611611 or go to www.3M.com.
2. Peel the liner from the dressing, exposing the adhesive surface.
3. Center the gel pad over the catheter site and smooth down dressing edges.
Do not stretch dressing during application. Mechanical skin trauma may result if the
dressing is applied with tension.
4. Slowly remove the frame while smoothing down the transparent film dressing
DRESSING SIZE
1657R
8.5 cm x 11.5 cm
(3-1/2 x 4-1/2 in)
45
1658R
10 cm x 12 cm
(4 x 4-3/4 in)
45
1659R
10 cm x 15.5 cm
(4 x 6-1/8 in)
78
edges.
5. Smooth the transparent film dressing from the center towards the edges, using firm
AVERAGE AMOUNT OF CHG PER DRESSING
(MG BASED ON GEL PAD SIZE)
CATALOG #
pressure to enhance adhesion.
6. The sterile tape strips can be used: under the catheter wings or hub – to protect the
skin; over the catheter wings or hub – to enhance catheter stability; to secure IV
tubing or to stabilize catheter lumens.
7. Document dressing change information on label according to facility’s protocol.
3M Health Care
St. Paul, MN 55144-1000
3M and Tegaderm are trademarks of 3M.
34-8701-5049-6
0086
Remove label from frame and place on the dressing.
2
LATEX
Site Care:
1. The site should be observed daily for signs of infection or other complications. If
infection is suspected, remove the dressing, inspect the site directly and determine
appropriate medical intervention. Infection may be signaled by fever, pain, redness,
swelling or unusual odor or discharge.
2. Change the dressing as necessary, in accordance with facility protocol; dressing
changes should occur at a minimum of every 7 days, per current Centers for
Disease Control and Prevention (CDC) recommendations. Dressing changes may be
needed more frequently with highly exudative sites.
Latex-Free
Sterile unless package
is damaged or open
STERILE
2
STERILIZE
EO
EC REP
3M Health Care
D-41453 Neuss, Germany
3M Health Care
St. Paul, MN 55144-1000
3M™ Tegaderm™ CHG
Chlorhexidine Gluconate IV Securement Dressing
Product Number
1657R
1658R
1659R
Product Size
8.5 cm x 11.5 cm
10 cm x 12 cm
10 cm x 15.5 cm
Gel Pad Size
3 cm x 4 cm
3 cm x 4 cm
3 cm x 7 cm
All CVCs
Arterial, Dialysis, Midline
Universal
All CVCs
PICC
1655
1616
1650
Suggested Devices
Same Size/Shape as
Non-Antimicrobial Dressing
3M Skin and Wound Division Europe,
Middle East and Africa
c/o 3M Deutschland GmbH
Carl-Schurz-Str.1
41453 Neuss
Phone.: +49 (0)21 31 / 14-3000
www.3MMedica.com
Please recycle.
3M and Tegaderm are trademarks of the 3M company.
© 3M 2010. All rights reserved.
(CH/Graphix)

The Evidence Is Clear

Transcription

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