Download Ex Vivo Comparative Analysis of Chlorhexidine Gluconate (CHG

Conclusion
The CDC recommends the use of CHG on the skin before and after placement of a central venous catheter as part of a strategy to
reduce CRBSIs. In this study, the CHG polyurethane foam disk provided better transfer of CHG to the porcine skin samples than did
the CHG hydrogel pad. This more efficient coverage of CHG is thought to be attributed to greater intimate contact between the skin
and the CHG polyurethane foam disk. Products that transfer CHG to the skin have been shown to reduce skin bacterial counts,11,13,16
reduce catheter colonization,8,13,14 and reduce CRBSIs.14
References
1. Maki DG, Kluger DM, Crnich CJ. The risk of bloodstream infection
in adults with different intravascular devices: a systematic review
of 200 published prospective studies. Mayo Clin Proc.
2006;81(9):1159-1171.
2. Warren DK, Quadir WW, Hollenbeak CS, Elward AM, Cox MJ,
Fraser VJ. Attributable cost of catheter-associated bloodstream
infections among intensive care patients in a nonteaching
hospital. Crit Care Med. 2006;34(8):2084-2089.
3. Shannon RP, Patel B, Cummins D, Shannon AH, Ganguli G, Lu Y.
Economics of central line–associated bloodstream infections. Am
J Med Qual. 2006;21(6 Suppl):7S-16S.
4. Burke JP. Infection control—a problem for patient safety. N Engl J
Med. 2003;348:651-656.
5. O’Grady NP, Alexander M, Dellinger EP, et al. Guidelines for the
prevention of intravascular catheter-related infections. MMWR
Recomm Rep. 2002;51(RR10):1-26.
6. Jackson MM. Topical antiseptics in healthcare. Clin Lab Sci.
2005;18(3):160.
7.
Data on file.
8. Shapiro JM, Bond EL, Garman JK. Use of a chlorhexidine dressing
to reduce microbial colonization of epidural catheters.
Anesthesiology. 1990;73(4):625-631.
11. Edmiston CE Jr, Krepel CJ, Seabrook GR, Lewis BD, Brown KR,
Towne JB. Reducing the risk of SSIs: evaluating skin antisepsis
using 4% chlorhexidine gluconate (CHG) soap versus 2% CHGimpregnated polyester cloth. Poster presented at: Annual
Congress of the Association of periOperative Registered Nurses;
March 2007; Orlando, FL.
12. Bhende MS, Rothenburger S. In vitro antimicrobial effectiveness
of 5 catheter insertion-site dressings. J Assoc Vascular Access.
2007;12(4):227-231.
Ex Vivo Com parative Analy sis of Chlorhexidine
Gluconate (CHG) Coverage on P orcine Skin
13. Mann TJ, Orlikowski CE, Gurrin LC, Keil AD. The effect of the
biopatch, a chlorhexidine impregnated dressing, on bacterial
colonization of epidural catheter exit sites. Anaesth Intensive
Care. 2001;29(6):600-603.
14. Maki DG, Mermel LA, Kluger D, et al. Prevention of intravascular
catheter-related infection-a prospective, randomized, controlled,
multicenter study. Abstracts of the 40th Interscience Conference
on Antimicrobial Agents and Chemotherapy, September 2000,
page 422.
15. Garcia R, Jendresky L, Nicolas F, Colbert L, Dumont Y. Adding a
chlorhexidine patch to the IHI bundle: goal zero in reducing
central line-associated bacteremia. Am J Infect Control.
2006;34(5):E42.
9. Hendley JO, Ashe KM. Effect of topical antimicrobial treatment on
aerobic bacteria in the stratum corneum of human skin.
Antimicrob Agents Chemother. 1991;35(4):627-631.
10. Ryder M, Balbinot J. Improving skin antisepsis: 2% No-Rinse CHG
Cloths improve antiseptic persistence on patient skin over 4%
CHG Rinse-Off Solution. Poster presented at: Annual Congress of
the Association for Professionals in Infection Control and
Epidemiology; June 2007; San Jose, CA.
©ETHICON, Inc. 2008
BP-065
Christopher Westergom, MS
ETHICON, Inc., Somerville, NJ
E x V i vo C o m p a r a t i ve A n a l ys i s o f C h l o r h ex i d i n e G l u c o n a t e ( C H G ) C ove r a g e o n Po r c i n e S k i n
Introduction
Methods
Discussion
Bloodstream infections associated with central vascular
access are a common complication, occurring at a rate of up
to 1.6 infections per 1000 catheter days.1 Catheter-related
bloodstream infections (CRBSIs) are associated with a
mortality rate of 51% in ICU (intensive care unit) patients
compared with a rate of 28% in patients without a CRBSI.2
CRBSIs not only increase morbidity and mortality rates but
also contribute significantly to medical care costs, which are
reported to range from $11,9713 to $56,0004 per infection.
This study explored CHG transfer to porcine skin samples with
2 different devices. All Experiments were run at ETHICON, Inc.
in Somerville, NJ.
Bacterial colonization of central
venous catheters is common. Any
breach in the skin, such as that
caused by catheter insertion,
increases the risk of infection; the
risk is related to the bacterial
colonization of the devices and
B
the surrounding skin.8 Whereas
an initial cleansing of the skin
with CHG or povidone iodine
lowers bacterial counts, one
cleansing of the skin is not
adequate to maintain lower skin
bacterial counts over time,
because bacterial counts quickly
Figure
return to normal after the
antiseptic is no longer present.8,9
Thus, persistent residual action of
an antiseptic is needed to
maintain lower bacterial counts on the skin.
The Centers for Disease Control and Prevention (CDC) have
published guidelines for preventing intravascular catheterrelated infections. The guidelines emphasize educating and
training healthcare providers who insert and maintain
catheters to use sterile barrier precautions during the
insertion of central venous catheters; avoid routine
replacement of central venous catheters as a strategy to
prevent infection; use antiseptic/antibiotic-impregnated shortterm venous catheters if the rate of infection is high, despite
adherence to other strategies; and use a 2% chlorhexidine
preparation for skin antisepsis.5
Without continual
suppression, bacteria on skin
surface can repopulate and
migrate to the bloodstream,
elevating risk of CRBSIs.
Chlorhexidine gluconate (CHG,C22H30Cl2N10·2C6H12O7) is a
commonly used skin antiseptic that disrupts microbial cell
membranes and is effective against a broad spectrum of
microbes.6 Furthermore, CHG is not affected by organic
matter (e.g., blood), binds to the skin, and remains active for
at least 6 hours.6
In the present study, we evaluated the properties of CHG
transfer to the skin by 2 different devices: a foam disk with
CHG (BIOPATCH®; ETHICON Inc., a Johnson & Johnson
Company, Somerville, NJ) and a hydrogel pad with CHG
(Tegaderm™ CHG; 3M™ Health Care, St Paul, MN).
Porcine skin samples were cut into 2-inch squares, rinsed
to remove debris and surfactant present from the
harvesting process, and placed in petri dishes on 2-inch
pieces of towel saturated with buffered saline to maintain
moisture during incubation.7
A 1.5-mm biopsy punch was used to make a hole in the
porcine skin to accommodate insertion of a catheter tube
(PowerPICC™ Solo Catheter; Bard Access Systems, Salt
Lake City, UT). The openings were made in the center of
the porcine samples for the foam disk with CHG and 1 cm
from the edge for the hydrogel pad with CHG.
The catheters were inserted into the porcine samples, and
either a CHG polyurethane foam disk or a CHG hydrogel pad
was applied. Each device was applied according to the
Instructions for Use documents provided with the device. The
samples were inspected to ensure a complete seal on the
porcine skin, placed into zip-seal bags containing towels
saturated with deionized water, and incubated at 30° C for
24 hours.
After incubation, the samples were removed from the bags,
and the dressing materials and catheters were removed from
the porcine samples and discarded. A 10-mL aliquot of freshly
prepared staining agent (sodium hypobromite solution:
7.8651 g of bromine in 10.0426 g of sodium hydroxide in 100
mL of deionized water) was then placed on the surface of the
porcine skin and allowed to oxidize for 30 seconds.
Chlorhexidine oxidizes in the presence of sodium hypobromite
and forms a red-orange stain.
The porcine samples were photographed immediately after
the 30-second oxidization period. The photographs were
compared to determine skin transfer of CHG with the 2
different delivery devices.
Results
Comparison of the photographs of the skin samples before and
after staining showed that CHG transferred to the skin only in
areas where intimate contact between the skin and the CHG
device was maintained. The porcine samples with the foam
disk with CHG in place and the subsequent staining pattern are
shown in Figure 1. Porcine samples with the hydrogel foam pad
in place and the subsequent staining pattern are shown in
Figure 2.
A
1:
A
A
A
B
B
B
A. BIOPATCH® in place.
B. The staining pattern of CHG residual
after application of sodium hypobromite.
Studies of CHG application suggest that residual amounts of CHG
increase with increasing CHG contact. A study in 24 subjects that
compared residual amounts of CHG after the use of 2% CHG no-rinse
cloths and after the use of a 4% CHG solution (which was rinsed off)
showed that the amount of CHG residual directly correlated with the
number of 2% CHG cloths used (P=0.0003), but not with the amount
of 4% CHG solution used.10 Similar results were found in a study by
Edmiston et al11, in which 70 subjects cleansed their skin with either a
4% CHG solution or a 2% no-rinse cloth. Residual amounts of CHG
were significantly higher at all anatomic sites in the subjects who used
the 2% no-rinse CHG cloths than in those who used a 4% CHG solution
(P<0.001 to P<0.0001). Edmiston et al11 note that optimal skin
asepsis is affected by contact time, CHG concentration, and when a
valid standardized protocol is used.
The use of CHG-containing devices appears to lower skin bacterial
counts and reduce colonization of the device. Bhende and
Rothenburger12 found that the foam disk with CHG had excellent
antimicrobial activity and sustained efficacy over a period of seven
days. Mann et al13 found that bacterial colonization at an epidural site
developed in significantly fewer (P=0.001) patients who used a foam
disk with CHG (3.45%) than in patients who used a control occlusive
film dressing (42%).
The use of a foam disk with CHG was shown to reduce the microbial
colonization of epidural catheters (P<0.006).8 The use of a foam disk
with CHG was also associated with fewer CRBSIs than was the use of
Figure 2:
A. Tegaderm™ CHG in place.
B. The staining pattern of CHG residual
after application of sodium hypobromite.
a control film dressing in adult patients with a central vascular access
line (relative risk: 0.38; 95% confidence interval: 0.16-0.89).14 The
addition of foam disk with CHG dressings to the bundle of other
guideline-driven recommendations for CRBSI prevention led to a
reduction in CRBSIs from 3.1 per 1000 catheter days to 0 per 1000
catheter days.15
The observed reductions in bacterial counts and in CRBSI rates may
be due to the ability of the dressing to transfer CHG onto the skin. In
this study, staining patterns observed on the porcine samples
corresponded with areas where CHG transferred from the device to
the porcine skin sample. The difference in the patterns indicates that
CHG only transfers onto the skin in areas where intimate skin contact
is maintained with the device. The design of the foam disk with CHG
allowed circumferential coverage and maintained skin contact
throughout the 24-hour incubation period. The comparator, the
hydrogel pad with CHG, provided less CHG transfer because it did not
provide circumferential coverage (the pad is placed on top of the
catheter) and did not have as much intimate contact with the skin at
the catheter insertion site. It is not possible to make conclusive
statements about the comparative clinical benefits of the 2 devices
based on a qualitative ex vivo study that did not measure bacterial
counts on the skin.