Skin prep

[Jennifer McCarthy]

Hi all – not sure if this has already been discussed and apologies if it
has – one of the orthopaedic surgeons here is requesting Chlorhexidine
2% with 70% alcohol (tinted red) as opposed to the 0.5% with 70% alcohol
for skin prep. Firstly, is there an advantage to using the 2% as opposed
to the 0.5% and if so would anyone have any literature to support this
Thanks
Jenny McCarthy
Maryvale Private Hospital
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[Glenys Harrington]

Hi Michael,

This may be the case in terms of what is available in Australia. Hence
hospital using either of these products for surgical skin preparation would
be wise to undertake an “offline risk assessment” until the
manufacturer/supplier has the correct TGA registration as this may take some
time as a significant amount of data is required for such registration.

In addition hospital would also be wise to stick with a preparation that is
recommended in the current literature (all be there is some debate about the
methodology of these studies) and a product that is has been recommended by
others rather than a preparation that at this point in time is recommended
for skin antisepsis prior to insertion of intravascular devices.

I see the NHS recommended 2% Chlorhexidine and Alcohol for surgical skin
preparation in there “High Impact Intervention Care Bundle to Prevent
Surgical Site Infection” link below

Ensure that 2% chlorhexidine gluconate in 70% isopropyl alcohol solution is
used for skin preparation (if patient sensitive, use povidone-iodine)

http://www.documents.hps.scot.nhs.uk/hai/infection-control/evidence-for-care
-bundles/key-recommendations/ssi/ssi-rec-6.pdf

Regards

Glenys

Glenys Harrington

Consultant

Infection Control Consultancy (ICC)

PO Box 5202

Middle Park

Victoria, 3206

Australia

H: +61 3 96902216

M: +61 404 816 434

infexion@ozemail.com.au

ABN 47533508426

Of Michael Wishart

Hi Glenys

Agreed. The main problem is that the only formulations of chlorhexidine and
alcohol that are tinted red (both 0.5% and 2% chlorhexidine content)
available in Australia are all from the same manufacturer and all only
licensed by TGA for hard surface disinfection. The red tint is a specific
requirements for some surgeons to enable them to easily visualise where the
skin has been prepped.

Cheers

Michael

Michael Wishart

Infection Control Coordinator

Holy Spirit Northside Private Hospital

627 Rode Road, Chermside, Qld 4032

t: (07) 3326 3068 | f: (07) 3607 2226

e: Michael.Wishart@svha.org.au

w:
http://www.holyspiritnorthside.org.au

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5th May 2014

5may2014_top

Of Glenys Harrington

Hi Michael,

Until companies have their products correctly registered with the TGA
(inclusive of the purpose of use and labelling) users (i.e.
hospitals/surgeons) assume liability for any injuries resulting from any
“off-label use”.

As it is difficult to find any recommendations or publications supporting
the use of >0.5% chlorhexidine and Alcohol for surgical skin preparation at
this point in time hospitals would be wise to undertake an “offline risk
assessment” and have it endorsed by their Infection Control committee before
proceeding.

Regards

Glenys

Glenys Harrington

Consultant

Infection Control Consultancy (ICC)

PO Box 5202

Middle Park

Victoria, 3206

Australia

H: +61 3 96902216

M: +61 404 816 434

infexion@ozemail.com.au

ABN 47533508426

Of Michael Wishart

Hi Matthias

I believe the labelling of the solution in question is more about TGA
licensing than the actual formulation of the solution. That has been
discussed here previously on this list. The manufacturer of that product has
never explicitly stated you cannot use this solution for skin antisepsis,
only that it is not current licensed for this use. A vexing issue indeed.

Cheers

Michael

Michael Wishart

Infection Control Coordinator

Holy Spirit Northside Private Hospital

627 Rode Road, Chermside, Qld 4032

t: (07) 3326 3068 | f: (07) 3607 2226

e: Michael.Wishart@svha.org.au

w:
http://www.holyspiritnorthside.org.au

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5th May 2014

5may2014_top

Of Matthias Maiwald (KKH)

Hi Glenys,

Thank you very much for these additional points.

I would like to add a few points for clarification.

It is indeed the case that the CDC Guidelines for the Prevention of
Intravascular Catheter-Related Infections 2011 state to “Prepare clean skin
with a >0.5% chlorhexidine preparation with alcohol” and that this cannot be
automatically inferred to surgical skin preparation. Apart from the IHI
document that you cited (apparently specifying 2%; I have not yet seen the
document), there does not seem to be a widely specified CHG percentage
(supported by data) to be added to the alcohol that is available in
guidelines.

The Carroll et al. 2014 study (from Melbourne) shows (in a non-RCT) for
surgical skin preparation that the combination of 1% iodine and 70% alcohol
(i.e. two antiseptics) performs better than a combination of 0.5% CHG and
70% alcohol (i.e. two antiseptics). Note that the type of iodine and the
alcohol types have not been specified in that study. These results seem
congruent with those of Swenson et al. ICHE 2009; 30: 964-71 (iodine+ALC
versus CHG+ALC).

The Darouiche et al. NEJM 2010 study clearly shows (in an RCT) for surgical
skin preparation that a combination of 2% CHG with 70% isopropanol (i.e. two
antiseptics) performs better than 10% povidone-iodine alone (i.e. only one
antiseptic). For anyone who has followed the microbiological literature on
antiseptics (which spans many decades), the outcome of this trial was hardly
surprising, because this is a massively unequal comparison: two antiseptics
against one, and the isopropanol in the 2%CHG/70%IPA trial arm outperforms
either CHG alone or PVI alone by a factor of 10 (!). Apart from that, it
indeed looks like the scientific part of the Darouiche trial is solid (as
you state).

The Carroll et al. 2014 study and the Darouiche et al. 2010 study — even in
synospsis — genuinely CANNOT be taken to infer that 0.5% CHG with alcohol
is any inferior to 2% CHG with alcohol (or vice versa).

I have not suggested to use alcohol alone for surgical skin preparation; the
combinations of either CHG+ALC or PVI+ALC have clear benefits of being
combination antiseptics with enhanced activity. What I was suggesting is
that people should get less hung up about the role of CHG in the CHG+ALC
combination. The microbiological properties of skin antiseptics have been
studied for over 100 years (e.g. Harrington and Walker. Boston Medical and
Surgical Journal. 1903; 148: 548-52), and a wealth of information
particularly came from studies done in the 1970s and 1980s. From this branch
of the literature, the microbiological properties of the various skin
antiseptics are well defined. Alcohols are known to be far superior in their
immediate antimicrobial activity than either CHG or PVI. While evidence from
clinical trials is clearly the best evidence, this evidence CANNOT be
assessed in isolation, and it is necessary — while assessing evidence — to
have a holistic picture with taking the necessary scientific background (in
this case: microbiological background) and the principles of biological
plausibility into account. That this was not commonly done in evidence
assessments for skin antisepsis — and people focussed blindly on clinical
trial outcomes — is presumably the reason for the massive, large-scale
medical literature error that we described in our PLoS One (2012) article
and subsequently commented upon further in our recent J Antimicrob Chemother
(2014) article.

The advice “Do not use to disinfect surfaces likely to come in contact with
broken skin” for the CHLORHEXIDINE 0.5% IN ALCOHOL 70% TINTED RED that you
mention presumably simply means that alcohol-containing antiseptics are
unsuitable to be used on wounds (also mucous membranes).

The range of CHG concentrations that I have seen in CHG+ALC combinations for
surgical skin preparation is 0.5% to 3.15% (the latter an odd number by one
particular manufacturer. The 4% CHG concentration would be typical of
aqueous CHG antiseptics (as John Ferguson states).

Best regards, Matthias.

—

Matthias Maiwald, MD, FRCPA

Consultant in Microbiology

Adj. Assoc. Prof., Natl. Univ. Singapore

Department of Pathology and Laboratory Medicine

KK Women’s and Children’s Hospital

100 Bukit Timah Road

Singapore 229899

Tel. +65 6394 8725 (Office)

Tel. +65 6394 1389 (Laboratory)

Fax +65 6394 1387

Of Glenys Harrington

Hi Matthias,

To access IHI information – you just need to register and then you can get
access to information such as the How to Guides – it’s free.

We should clarify for those following this thread that the CDC reference
to “Prepare clean skin with a >0.5% chlorhexidine preparation with
alcohol……” is referring to skin preparation for intravascular devices
not surgical (preoperative) skin preparation – extract from guidelines
below.

Guidelines for the Prevention of Intravascular Catheter-Related Infections,
2011

. “Prepare clean skin with a >0.5% chlorhexidine preparation with
alcohol before central venous catheter and peripheral arterial catheter
insertion and during dressing changes. If there is a contraindication to
chlorhexidine, tincture of iodine, an iodophor, or 70% alcohol can be used
as alternatives [82, 83]. Category IA”

While there may be supportive evidence for >0.5% chlorhexidine and alcohol
preparations for the prevention of catheter-related bloodstream infections
we shouldn’t assume that this will necessarily be the case for reducing
surgical site infections(SSIs). Hence until we see the studies that clearly
demonstrate that alcohol alone is better that CHG and alcohol, Iodine and
alcohol, CHG alone or Iodine alone for surgical (preoperative) skin
preparation to prevent surgical site infections we should be cautious about
what we suggest people focus on.

This recent publication from St Vincent’s Hospital, Melbourne may be of
interest to those considering a 0.5% CHG and alcohol preparation for
surgical (preoperative) skin preparation

The study showed that patients who received skin prep with 0.5%
chlorhexidine and alcohol prior to orthopaedic surgical procedures were at
higher risk of superficial infection than those who received 1% iodine
and alcohol, p=0.012.

Carroll K. et al. Risk factors for superficial wound complications in hip
and knee arthroplasty. Clinical Microbiology and Infection,

Volume 20, Issue 2, pages 130-135, February 2014

. “The study was performed over an 18-month period (January 2011 to
June 2012) and included 964 patients undergoing prosthetic hip or knee
replacement surgery

. In the multivariable logistic regression analysis patients who
received skin prep with 0.5% chlorhexidine and alcohol were at higher
risk of superficial infection than those who received 1% iodine and
alcohol, p=0.012.

. The authors acknowledge findings may reflect surgeon preference
and experience and that skin prep requires more evaluation/RCT”.

.

Thanks for forwarding the ProPublica scandal publication, very interesting
reading.

I see the US company concerned settled with the US Dept of Justice avoiding
criminal charges for allegations of fraud against the government and the
product is now approved by the FDA as outlined in a US Department of Justice
Press Release titled “CareFusion to Pay the Government $40.1 Million to
Resolve Allegations That Include More Than $11 Million in Kickbacks to One
Doctor” on Thursday, January 9, 2014:

. ” The settlement resolves allegations that, under agreements
entered into in 2008 by CareFusion’s predecessor, CareFusion paid $11.6
million in kickbacks to Dr. Charles Denham while Denham served as the
co-chair of the Safe Practices Committee at the National Quality Forum, a
non-profit organization that reviews, endorses and recommends standardized
health care performance measures and practices. The government contends
that the purpose of those payments was to induce Denham to recommend,
promote and arrange for the purchase of ChloraPrep by health care providers.
ChloraPrep has been approved by the Food and Drug Administration for the
preparation of a patient’s skin prior to surgery or injection”.

. “This settlement also resolves allegations that, during the period
between September 2009 and August 2011, CareFusion knowingly promoted the
sale of ChloraPrep for uses that were not approved by the Food and Drug
Administration, some of which were not medically accepted indications, and
made unsubstantiated representations about the appropriate uses of
ChloraPrep. ChloraPrep has been approved by the Food and Drug Administration
for the preparation of a patient’s skin prior to surgery or injection”.

http://www.justice.gov/opa/pr/2014/January/14-civ-021.html

http://www.ag.ny.gov/pdfs/Settlement_Agreement.pdf

In addition the product concerned has also been registered with the TGA in
Australia and is on the ARTG list for use as “Sterile tinted antiseptic
applied to patient’s skin prior to invasive medical procedures”.

https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.ns
f

&docidC1698728A822FDCA257CA5003CC3EC&agid=(PrintDetailsPublic)&actionid=1

While the FDA discredited the NEJM publication in court proceedings as
outlined at the ProPublica link I don’t see where the publication it has
been discredited by the NEJM nor the U.S. National Institutes of Health,
Clinical Trials Unit who approved the trail?

Given that the allegations of impropriety and kickbacks where towards Dr.
Charles Denham, who was not an author of the NEJM publication and the trail
was a randomized, double-blind, placebo-controlled trial and conflicts of
interest were disclosed the results and conclusion below may still be
valid.

Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis N
Engl J Med 2010;362:18-26.

Results

“A total of 849 subjects (409 in the chlorhexidine-alcohol group and 440 in
the povidone-iodine group) qualified for the intention-to-treat analysis.
The overall rate of surgical-site infection was significantly lower in the
chlorhexidine-alcohol group than in the povidone-iodine group (9.5% vs.
16.1%; P = 0.004; relative risk, 0.59; 95% confidence interval, 0.41 to
0.85). Chlorhexidine-alcohol was significantly more protective than
povidone-iodine against both superficial incisional infections (4.2% vs.
8.6%, P = 0.008) and deep incisional infections (1% vs. 3%, P = 0.05) but
not against organ-space infections (4.4% vs. 4.5%). Similar results were
observed in the per-protocol analysis of the 813 patients who remained in
the study during the 30-day follow-up period. Adverse events were similar in
the two study groups”.

Conclusion

“Preoperative cleansing of the patient’s skin with chlorhexidine-alcohol is
superior to cleansing with povidone-iodine for preventing surgical-site
infection after clean contaminated surgery. (ClinicalTrials.gov number,
NCT00290290.)

In addition I think you will find in the US that there are only 2
concentrations of CHG and alcohol available for surgical (preoperative) skin
preparation – 2% or 4 % – happy to be corrected.

In Australia the supplier/manufacturer of the CHLORHEXIDINE 0.5% IN
ALCOHOL 70% TINTED RED that I think jenny is referring to states the
following on their users product guide:

. Do not use to disinfect therapeutic devices.

. Do not use to disinfect surfaces likely to come in contact with
broken skin.

Regards

Glenys

Glenys Harrington

Consultant

Infection Control Consultancy (ICC)

PO Box 5202

Middle Park

Victoria, 3206

Australia

H: +61 3 96902216

M: +61 404 816 434

infexion@ozemail.com.au

ABN 47533508426

Of Matthias Maiwald (KKH)

Hi Glenys,

Interesting. I had not yet seen the IHI Project JOINTS website. Some of the
contents seem to be behind a login-wall, though.

The “2%” CHX specified percentage brings up an interesting issue; there was
a recent US healthcare scandal in which it is alleged that an ex committee
member of the US National Quality Forum (NQF) inappropriately influenced the
NQF towards a 2% CHG-containing solution, at a time when only one
manufacturer provided that particular percentage (meaning a 2% endorsement
would direct consumers towards that manufacturer’s product) and at a time
when there was no clear evidence to prefer a particular CHX percentage over
another (as John Ferguson states).

http://www.propublica.org/article/hidden-financial-ties-rattle-top-health-qu
ality-group

People should not get so focused on the CHX component; as I have often
emphasised, it is known from many decades of microbiological testing both in
vitro and on human skin that alcohols, when well formulated, are about 10
times more microbiologically effective than CHX.

Interesting, the second reference (2014 Update) lists routine preoperative
CHX showering/bathing/wiping as an unresolved issue. While this practice is
supported by a good microbiological rationale (and those who know me know
that I like microbiological rationales), it is not yet quite established
whether this translates into better clinical outcomes. Note, this is
different from specific preoperative decolonisation of MSSA/MRSA cariers,
which seems indeed to translate into better outcomes. Also, for classical
skin antisepsis (‘skin prep’) as discussed above, it is also well
established that this translates into outcomes.

Best regards, Matthias.

—

Matthias Maiwald, MD, FRCPA

Consultant in Microbiology

Adj. Assoc. Prof., Natl. Univ. Singapore

Department of Pathology and Laboratory Medicine

KK Women’s and Children’s Hospital

100 Bukit Timah Road

Singapore 229899

Tel. +65 6394 8725 (Office)

Tel. +65 6394 1389 (Laboratory)

Fax +65 6394 1387

Of Glenys Harrington

Hi Jenny,

Sorry to join the discussion in relation to surgical preoperative skin
preparation late.

Your surgeons request may relate to the Institute of Healthcare Improvement
(IHI) Project JOINTS.

http://www.ihi.org/engage/initiatives/completed/projectjoints/Pages/default.
aspx

In addition to the interventions recommended by the Surgical Care
Improvement Project (SCIP) (i.e. appropriate use of prophylactic
antibiotics, appropriate hair removal…and so on) Project JOINTS recommends
the following interventions for elective hip and knee arthroplasty
procedures:

1. Use of an alcohol-containing antiseptic agent for preoperative skin
preparation.

Hospitals participating in the IHI Project JOINTS are using one of the
following surgical preoperative skin preparations (personal communication):

o 2% CHG plus alcohol

*10% Iodophor plus alcohol

You can find additional information in the IHI Project JOINTS, “How to
Guide” including the following.

. IHI Project JOINTS How-to Guide: Prevent Surgical Site Infection
for Hip and Knee Arthroplasty: “The combination of a long-acting agent
(either an iodophor or CHG) is better than povidone iodine alone for
preventing SSI. There is insufficient evidence to support recommending the
use of one combination agent over another”.

2. Preoperative bathing or showering with chlorhexidine gluconate (CHG)
soap for at least three days before surgery – most are using CHG wipes
(personal communication).

3. Staphylococcus aureus screening and use of intranasal mupirocin and CHG
bathing or showering to decolonize Staphylococcus aureus carriers.

In addition the recent publication from the Society for Healthcare
Epidemiology of America (SHEA) and the Infectious Diseases Society of
America (IDSA) Practice Recommendations “Strategies to Prevent Surgical Site
Infections in Acute Care Hospitals: 2014 Update – Intervention number one
is a Grade 1 (high) level of evidence recommendation and may be worth a
read.

“Use alcohol-containing preoperative skin preparatory agents if no
contraindication exists (quality of evidence: I).

a. Alcohol is highly bactericidal and effective for preoperative skin
antisepsis but does not have persistent activity when used alone. Rapid,
persistent, and cumulative antisepsis can be achieved by combining alcohol
with chlorhexidine gluconate or an iodophor.115

i. Alcohol is contraindicated for certain procedures, including procedures
in which the preparatory agent may pool or not dry (e.g., involving hair)
due to fire risk. Alcohol may also be contraindicated for procedures
involving mucosa, cornea, or ear.

b. The most effective disinfectant to combine with alcohol is unclear…”.

The publication is freely available online at the following link:
http://www.jstor.org/stable/10.1086/676022

Your surgeon may want a tinted product so he/she can see where it has been
applied, although any staining (tinted CHG or Idophor) may obscure signs of
inflammation post-operatively.

regards

Glenys

Glenys Harrington

Consultant

Infection Control Consultancy (ICC)

PO Box 5202

Middle Park

Victoria, 3206

Australia

H: +61 3 96902216

M: +61 404 816 434

infexion@ozemail.com.au

ABN 47533508426

Of Jenny McCarthy

thankyou to everyone who responded to my question – its given me a great
basis for discusssion with the ortho surgeon !!

_____

Of Matthias Maiwald (KKH)

Hi John,

I was actually considering remaining in the background for this particular
discussion. You make very good points. The (potentially) increased incidence
of skin reactions is interesting information that may be worth publishing if
you can.

One may want to bear in mind that different applications of skin antisepsis
(e.g. blood culture collection, surgical skin prep, vascular catheter
insertion) have different functional and physiological characteristics and
requirements, and for surgical skin preparation (Jenny’s question), the
question of chlorhexidine/alcohol versus povidone-iodine/alcohol is
unresolved. Chlorhexidine/alcohol is an excellent choice, but iodine/alcohol
should not be discounted for this purpose.

Best regards, Matthias.

—

Matthias Maiwald, MD, FRCPA

Consultant in Microbiology

Adj. Assoc. Prof., Natl. Univ. Singapore

Department of Pathology and Laboratory Medicine

KK Women’s and Children’s Hospital

100 Bukit Timah Road

Singapore 229899

Tel. +65 6394 8725 (Office)

Tel. +65 6394 1389 (Laboratory)

Fax +65 6394 1387

Of John Ferguson

Dear Jenny

The critical point is that when chlorhex is mixed with alcohol , there is no
apparent benefit from exceeding 0.5%.

The old literature on 2% C and lines related to an aqueous preparation.

Furthermore, we found an increase in skin reactions to the more concentrated
products (went to a poster).

Matthias M will comment no doubt – he has recently published this piece that
is of relevance – Maiwald M, Chan ESY. Pitfalls in evidence assessment: the
case of chlorhexidine and alcohol in skin antisepsis (Leading Article). J.
Antimicrob. Chemother. (2014) Advance Access.

http://jac.oxfordjournals.org/content/early/2014/04/28/jac.dku121.abstract

Kind regards

John

Dr John Ferguson

Infectious Diseases & Microbiology

+61 428 885573

Of Tim Spencer

Hi Jenny,
There is lots of supportive evidence for 2%CHG in 70%IPA, particularly for
invasive device skin preparation (CVC/PICC/PIVC,ICC/Epidural, etc,etc..)
Here is a link to Dr William Jarvis discussing the differences of various
skin preps.
http://www.medscape.com/viewarticle/761489
There is both a video of the discussion..
To cut to the conclusion;
The findings were very interesting. Of greatest importance, the
investigators found that all products (0.5% chlorhexidine with ethanol, 1%
chlorhexidine with ethanol, and 2% chlorhexidine with isopropyl alcohol)
were equally effective. This will be very helpful information when you are
trying to select a product for preparation of the insertion site for
intravascular catheters or for a preoperative surgical antiseptic.
Chlorhexidine is effective, and different concentrations of chlorhexidine
are equally effective, with no statistically significant difference in
colony counts. All of these products should be equally beneficial to
patients in preventing central line-associated bloodstream infections or
surgical site infections.

Timothy R. Spencer, RN, APN, DipAppSci, Bach.Health, ICCert.
Clinical Nurse Consultant, Central Venous Access & Parenteral Nutrition
Service
Conjoint Lecturer, South West Sydney Clinical School | Faculty of Medicine |
University of NSW
President, Australian Vascular Access Society
Dept of Intensive Care, Level 2, Clinical Building, Liverpool Hospital,
Elizabeth Street, Liverpool, 2170, NSW, Australia
Tel (+61) 2 8738 3603 | Fax (+61) 2 8738 3551 | Mob +61 (0)409 463 428 |
Tim.Spencer@sswahs.nsw.gov.au | Timothy.Spencer@unsw.edu.au

“Be a yardstick of quality. Some people aren’t used to an environment where
excellence is expected.” – Steve Jobs

_____

McCarthy [jenny@MARYVALEPH.COM.AU]

Hi all – not sure if this has already been discussed and apologies if it has
– one of the orthopaedic surgeons here is requesting Chlorhexidine 2% with
70% alcohol (tinted red) as opposed to the 0.5% with 70% alcohol for skin
prep. Firstly, is there an advantage to using the 2% as opposed to the 0.5%
and if so would anyone have any literature to support this

Thanks
Jenny McCarthy
Maryvale Private Hospital

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[Matthias Maiwald (KKH)]

Hi Glenys,

There is certainly a point to be made to use something that is commonly used and/or mentioned in guidelines. Just bear in mind that guidelines do not operate in a “vacuum”, and in the Scottish recommendation that you cite, based on the literature that they analysed and cited within the document, the support for >>EXACTLY<< 2% chlorhexidine and 70% isopropanol is underwhelming, to say it mildly.

Based on the published antimicrobially active concentration ranges of antiseptics and what is usually used in products for this purpose, the 2% chlorhexidine 70% isopropanol combination is clearly an excellent choice — with this I agree wholeheartedly — but there are also other possible and reasonable concentration choices. Also, again, bear in mind that the question of chlorhexidine + alcohol versus povidone-iodine + alcohol for surgical skin antisepsis (which is what we are talking about) is unresolved.

As mentioned in my earlier comment, the focus on exactly 2% chlorhexidine was also part of a recent US healthcare scandal.

Best regards, Matthias.

—
Matthias Maiwald, MD, FRCPA
Consultant in Microbiology
Adj. Assoc. Prof., Natl. Univ. Singapore
Department of Pathology and Laboratory Medicine
KK Women's and Children's Hospital
100 Bukit Timah Road
Singapore 229899
Tel. +65 6394 8725 (Office)
Tel. +65 6394 1389 (Laboratory)
Fax +65 6394 1387

Hi Michael,

This may be the case in terms of what is available in Australia. Hence hospital using either of these products for surgical skin preparation would be wise to undertake an "offline risk assessment" until the manufacturer/supplier has the correct TGA registration as this may take some time as a significant amount of data is required for such registration.

In addition hospital would also be wise to stick with a preparation that is recommended in the current literature (all be there is some debate about the methodology of these studies) and a product that is has been recommended by others rather than a preparation that at this point in time is recommended for skin antisepsis prior to insertion of intravascular devices.

I see the NHS recommended 2% Chlorhexidine and Alcohol for surgical skin preparation in there "High Impact Intervention Care Bundle to Prevent Surgical Site Infection" link below

Ensure that 2% chlorhexidine gluconate in 70% isopropyl alcohol solution is used for skin preparation (if patient sensitive, use povidone-iodine)
http://www.documents.hps.scot.nhs.uk/hai/infection-control/evidence-for-care-bundles/key-recommendations/ssi/ssi-rec-6.pdf

Regards

Glenys

Glenys Harrington
Consultant
Infection Control Consultancy (ICC)

PO Box 5202
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Australia
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Hi Glenys

Agreed. The main problem is that the only formulations of chlorhexidine and alcohol that are tinted red (both 0.5% and 2% chlorhexidine content) available in Australia are all from the same manufacturer and all only licensed by TGA for hard surface disinfection. The red tint is a specific requirements for some surgeons to enable them to easily visualise where the skin has been prepped.

Cheers
Michael

Michael Wishart
Infection Control Coordinator
Holy Spirit Northside Private Hospital
627 Rode Road, Chermside, Qld 4032
t: (07) 3326 3068 | f: (07) 3607 2226
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5th May 2014

Hi Michael,

Until companies have their products correctly registered with the TGA (inclusive of the purpose of use and labelling) users (i.e. hospitals/surgeons) assume liability for any injuries resulting from any “off-label use”.

As it is difficult to find any recommendations or publications supporting the use of >0.5% chlorhexidine and Alcohol for surgical skin preparation at this point in time hospitals would be wise to undertake an “offline risk assessment” and have it endorsed by their Infection Control committee before proceeding.

Regards

Glenys

Glenys Harrington
Consultant
Infection Control Consultancy (ICC)

PO Box 5202
Middle Park
Victoria, 3206
Australia
H: +61 3 96902216
M: +61 404 816 434
infexion@ozemail.com.au
ABN 47533508426

Hi Matthias

I believe the labelling of the solution in question is more about TGA licensing than the actual formulation of the solution. That has been discussed here previously on this list. The manufacturer of that product has never explicitly stated you cannot use this solution for skin antisepsis, only that it is not current licensed for this use. A vexing issue indeed.

Cheers
Michael

Michael Wishart
Infection Control Coordinator
Holy Spirit Northside Private Hospital
627 Rode Road, Chermside, Qld 4032
t: (07) 3326 3068 | f: (07) 3607 2226
e: Michael.Wishart@svha.org.au
w:www.holyspiritnorthside.org.au
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5th May 2014

Hi Glenys,

Thank you very much for these additional points.

I would like to add a few points for clarification.

It is indeed the case that the CDC Guidelines for the Prevention of Intravascular Catheter-Related Infections 2011 state to “Prepare clean skin with a >0.5% chlorhexidine preparation with alcohol” and that this cannot be automatically inferred to surgical skin preparation. Apart from the IHI document that you cited (apparently specifying 2%; I have not yet seen the document), there does not seem to be a widely specified CHG percentage (supported by data) to be added to the alcohol that is available in guidelines.

The Carroll et al. 2014 study (from Melbourne) shows (in a non-RCT) for surgical skin preparation that the combination of 1% iodine and 70% alcohol (i.e. two antiseptics) performs better than a combination of 0.5% CHG and 70% alcohol (i.e. two antiseptics). Note that the type of iodine and the alcohol types have not been specified in that study. These results seem congruent with those of Swenson et al. ICHE 2009; 30: 964-71 (iodine+ALC versus CHG+ALC).

The Darouiche et al. NEJM 2010 study clearly shows (in an RCT) for surgical skin preparation that a combination of 2% CHG with 70% isopropanol (i.e. two antiseptics) performs better than 10% povidone-iodine alone (i.e. only one antiseptic). For anyone who has followed the microbiological literature on antiseptics (which spans many decades), the outcome of this trial was hardly surprising, because this is a massively unequal comparison: two antiseptics against one, and the isopropanol in the 2%CHG/70%IPA trial arm outperforms either CHG alone or PVI alone by a factor of 10 (!). Apart from that, it indeed looks like the scientific part of the Darouiche trial is solid (as you state).

The Carroll et al. 2014 study and the Darouiche et al. 2010 study — even in synospsis — genuinely CANNOT be taken to infer that 0.5% CHG with alcohol is any inferior to 2% CHG with alcohol (or vice versa).

I have not suggested to use alcohol alone for surgical skin preparation; the combinations of either CHG+ALC or PVI+ALC have clear benefits of being combination antiseptics with enhanced activity. What I was suggesting is that people should get less hung up about the role of CHG in the CHG+ALC combination. The microbiological properties of skin antiseptics have been studied for over 100 years (e.g. Harrington and Walker. Boston Medical and Surgical Journal. 1903; 148: 548-52), and a wealth of information particularly came from studies done in the 1970s and 1980s. From this branch of the literature, the microbiological properties of the various skin antiseptics are well defined. Alcohols are known to be far superior in their immediate antimicrobial activity than either CHG or PVI. While evidence from clinical trials is clearly the best evidence, this evidence CANNOT be assessed in isolation, and it is necessary — while assessing evidence — to have a holistic picture with taking the necessary scientific background (in this case: microbiological background) and the principles of biological plausibility into account. That this was not commonly done in evidence assessments for skin antisepsis — and people focussed blindly on clinical trial outcomes — is presumably the reason for the massive, large-scale medical literature error that we described in our PLoS One (2012) article and subsequently commented upon further in our recent J Antimicrob Chemother (2014) article.

The advice “Do not use to disinfect surfaces likely to come in contact with broken skin” for the CHLORHEXIDINE 0.5% IN ALCOHOL 70% TINTED RED that you mention presumably simply means that alcohol-containing antiseptics are unsuitable to be used on wounds (also mucous membranes).

The range of CHG concentrations that I have seen in CHG+ALC combinations for surgical skin preparation is 0.5% to 3.15% (the latter an odd number by one particular manufacturer. The 4% CHG concentration would be typical of aqueous CHG antiseptics (as John Ferguson states).

Best regards, Matthias.

—
Matthias Maiwald, MD, FRCPA
Consultant in Microbiology
Adj. Assoc. Prof., Natl. Univ. Singapore
Department of Pathology and Laboratory Medicine
KK Women’s and Children’s Hospital
100 Bukit Timah Road
Singapore 229899
Tel. +65 6394 8725 (Office)
Tel. +65 6394 1389 (Laboratory)
Fax +65 6394 1387

Hi Matthias,

To access IHI information – you just need to register and then you can get access to information such as the How to Guides – it’s free.

We should clarify for those following this thread that the CDC reference to “Prepare clean skin with a >0.5% chlorhexidine preparation with alcohol…………….” is referring to skin preparation for intravascular devices not surgical (preoperative) skin preparation – extract from guidelines below.

Guidelines for the Prevention of Intravascular Catheter-Related Infections, 2011

* “Prepare clean skin with a >0.5% chlorhexidine preparation with alcohol before central venous catheter and peripheral arterial catheter insertion and during dressing changes. If there is a contraindication to chlorhexidine, tincture of iodine, an iodophor, or 70% alcohol can be used as alternatives [82, 83]. Category IA”

While there may be supportive evidence for >0.5% chlorhexidine and alcohol preparations for the prevention of catheter-related bloodstream infections we shouldn’t assume that this will necessarily be the case for reducing surgical site infections(SSIs). Hence until we see the studies that clearly demonstrate that alcohol alone is better that CHG and alcohol, Iodine and alcohol, CHG alone or Iodine alone for surgical (preoperative) skin preparation to prevent surgical site infections we should be cautious about what we suggest people focus on.

This recent publication from St Vincent’s Hospital, Melbourne may be of interest to those considering a 0.5% CHG and alcohol preparation for surgical (preoperative) skin preparation

The study showed that patients who received skin prep with 0.5% chlorhexidine and alcohol prior to orthopaedic surgical procedures were at higher risk of superficial infection than those who received 1% iodine and alcohol, p0.012.

Carroll K. et al. Risk factors for superficial wound complications in hip and knee arthroplasty. Clinical Microbiology and Infection, Volume 20, Issue 2, pages 130-135, February 2014

* “The study was performed over an 18-month period (January 2011 to June 2012) and included 964 patients undergoing prosthetic hip or knee replacement surgery

* In the multivariable logistic regression analysis patients who received skin prep with 0.5% chlorhexidine and alcohol were at higher risk of superficial infection than those who received 1% iodine and alcohol, p0.012.

* The authors acknowledge findings may reflect surgeon preference and experience and that skin prep requires more evaluation/RCT”.

*
Thanks for forwarding the ProPublica scandal publication, very interesting reading.

I see the US company concerned settled with the US Dept of Justice avoiding criminal charges for allegations of fraud against the government and the product is now approved by the FDA as outlined in a US Department of Justice Press Release titled “CareFusion to Pay the Government $40.1 Million to Resolve Allegations That Include More Than $11 Million in Kickbacks to One Doctor” on Thursday, January 9, 2014:

* ” The settlement resolves allegations that, under agreements entered into in 2008 by CareFusion’s predecessor, CareFusion paid $11.6 million in kickbacks to Dr. Charles Denham while Denham served as the co-chair of the Safe Practices Committee at the National Quality Forum, a non-profit organization that reviews, endorses and recommends standardized health care performance measures and practices. The government contends that the purpose of those payments was to induce Denham to recommend, promote and arrange for the purchase of ChloraPrep by health care providers. ChloraPrep has been approved by the Food and Drug Administration for the preparation of a patient’s skin prior to surgery or injection”.

* “This settlement also resolves allegations that, during the period between September 2009 and August 2011, CareFusion knowingly promoted the sale of ChloraPrep for uses that were not approved by the Food and Drug Administration, some of which were not medically accepted indications, and made unsubstantiated representations about the appropriate uses of ChloraPrep. ChloraPrep has been approved by the Food and Drug Administration for the preparation of a patient’s skin prior to surgery or injection”.
http://www.justice.gov/opa/pr/2014/January/14-civ-021.html
http://www.ag.ny.gov/pdfs/Settlement_Agreement.pdf

In addition the product concerned has also been registered with the TGA in Australia and is on the ARTG list for use as “Sterile tinted antiseptic applied to patient’s skin prior to invasive medical procedures”.

https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbidebs/PublicHTML/pdfStore.nsf&docidD9C1698728A822FDCA257CA5003CC3EC&agid(PrintDetailsPublic)&actionid1

While the FDA discredited the NEJM publication in court proceedings as outlined at the ProPublica link I don’t see where the publication it has been discredited by the NEJM nor the U.S. National Institutes of Health, Clinical Trials Unit who approved the trail?

Given that the allegations of impropriety and kickbacks where towards Dr. Charles Denham, who was not an author of the NEJM publication and the trail was a randomized, double-blind, placebo-controlled trial and conflicts of interest were disclosed the results and conclusion below may still be valid.

Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis N Engl J Med 2010;362:18-26.

Results

“A total of 849 subjects (409 in the chlorhexidine-alcohol group and 440 in the povidone-iodine group) qualified for the intention-to-treat analysis. The overall rate of surgical-site infection was significantly lower in the chlorhexidine-alcohol group than in the povidone-iodine group (9.5% vs. 16.1%; P 0.004; relative risk, 0.59; 95% confidence interval, 0.41 to 0.85). Chlorhexidine-alcohol was significantly more protective than povidone-iodine against both superficial incisional infections (4.2% vs. 8.6%, P 0.008) and deep incisional infections (1% vs. 3%, P 0.05) but not against organ-space infections (4.4% vs. 4.5%). Similar results were observed in the per-protocol analysis of the 813 patients who remained in the study during the 30-day follow-up period. Adverse events were similar in the two study groups”.

Conclusion

“Preoperative cleansing of the patient’s skin with chlorhexidine-alcohol is superior to cleansing with povidone-iodine for preventing surgical-site infection after clean contaminated surgery. (ClinicalTrials.gov number, NCT00290290.)

In addition I think you will find in the US that there are only 2 concentrations of CHG and alcohol available for surgical (preoperative) skin preparation – 2% or 4 % – happy to be corrected.

In Australia the supplier/manufacturer of the CHLORHEXIDINE 0.5% IN ALCOHOL 70% TINTED RED that I think jenny is referring to states the following on their users product guide:

* Do not use to disinfect therapeutic devices.

* Do not use to disinfect surfaces likely to come in contact with broken skin.

Regards

Glenys

Glenys Harrington
Consultant
Infection Control Consultancy (ICC)

PO Box 5202
Middle Park
Victoria, 3206
Australia
H: +61 3 96902216
M: +61 404 816 434
infexion@ozemail.com.au
ABN 47533508426

Hi Glenys,

Interesting. I had not yet seen the IHI Project JOINTS website. Some of the contents seem to be behind a login-wall, though.

The “2%” CHX specified percentage brings up an interesting issue; there was a recent US healthcare scandal in which it is alleged that an ex committee member of the US National Quality Forum (NQF) inappropriately influenced the NQF towards a 2% CHG-containing solution, at a time when only one manufacturer provided that particular percentage (meaning a 2% endorsement would direct consumers towards that manufacturer’s product) and at a time when there was no clear evidence to prefer a particular CHX percentage over another (as John Ferguson states).

http://www.propublica.org/article/hidden-financial-ties-rattle-top-health-quality-group

People should not get so focused on the CHX component; as I have often emphasised, it is known from many decades of microbiological testing both in vitro and on human skin that alcohols, when well formulated, are about 10 times more microbiologically effective than CHX.

Interesting, the second reference (2014 Update) lists routine preoperative CHX showering/bathing/wiping as an unresolved issue. While this practice is supported by a good microbiological rationale (and those who know me know that I like microbiological rationales), it is not yet quite established whether this translates into better clinical outcomes. Note, this is different from specific preoperative decolonisation of MSSA/MRSA cariers, which seems indeed to translate into better outcomes. Also, for classical skin antisepsis (‘skin prep’) as discussed above, it is also well established that this translates into outcomes.

Best regards, Matthias.

—
Matthias Maiwald, MD, FRCPA
Consultant in Microbiology
Adj. Assoc. Prof., Natl. Univ. Singapore
Department of Pathology and Laboratory Medicine
KK Women’s and Children’s Hospital
100 Bukit Timah Road
Singapore 229899
Tel. +65 6394 8725 (Office)
Tel. +65 6394 1389 (Laboratory)
Fax +65 6394 1387

Hi Jenny,

Sorry to join the discussion in relation to surgical preoperative skin preparation late.

Your surgeons request may relate to the Institute of Healthcare Improvement (IHI) Project JOINTS.
http://www.ihi.org/engage/initiatives/completed/projectjoints/Pages/default.aspx

In addition to the interventions recommended by the Surgical Care Improvement Project (SCIP) (i.e. appropriate use of prophylactic antibiotics, appropriate hair removal…..and so on) Project JOINTS recommends the following interventions for elective hip and knee arthroplasty procedures:

1. Use of an alcohol-containing antiseptic agent for preoperative skin preparation.

Hospitals participating in the IHI Project JOINTS are using one of the following surgical preoperative skin preparations (personal communication):

o 2% CHG plus alcohol

* 10% Iodophor plus alcohol
You can find additional information in the IHI Project JOINTS, “How to Guide” including the following.

* IHI Project JOINTS How-to Guide: Prevent Surgical Site Infection for Hip and Knee Arthroplasty: “The combination of a long-acting agent (either an iodophor or CHG) is better than povidone iodine alone for preventing SSI. There is insufficient evidence to support recommending the use of one combination agent over another”.
2. Preoperative bathing or showering with chlorhexidine gluconate (CHG) soap for at least three days before surgery – most are using CHG wipes (personal communication).
3. Staphylococcus aureus screening and use of intranasal mupirocin and CHG bathing or showering to decolonize Staphylococcus aureus carriers.

In addition the recent publication from the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA) Practice Recommendations “Strategies to Prevent Surgical Site Infections in Acute Care Hospitals: 2014 Update – Intervention number one is a Grade 1 (high) level of evidence recommendation and may be worth a read.

“Use alcohol-containing preoperative skin preparatory agents if no contraindication exists (quality of evidence: I).
a. Alcohol is highly bactericidal and effective for preoperative skin antisepsis but does not have persistent activity when used alone. Rapid, persistent, and cumulative antisepsis can be achieved by combining alcohol with chlorhexidine gluconate or an iodophor.115
i. Alcohol is contraindicated for certain procedures, including procedures in which the preparatory agent may pool or not dry (e.g., involving hair) due to fire risk. Alcohol may also be contraindicated for procedures involving mucosa, cornea, or ear.
b. The most effective disinfectant to combine with alcohol is unclear…….”.

The publication is freely available online at the following link: http://www.jstor.org/stable/10.1086/676022

Your surgeon may want a tinted product so he/she can see where it has been applied, although any staining (tinted CHG or Idophor) may obscure signs of inflammation post-operatively.

regards

Glenys

Glenys Harrington
Consultant
Infection Control Consultancy (ICC)

PO Box 5202
Middle Park
Victoria, 3206
Australia
H: +61 3 96902216
M: +61 404 816 434
infexion@ozemail.com.au
ABN 47533508426

thankyou to everyone who responded to my question – its given me a great basis for discusssion with the ortho surgeon !!

________________________________
Hi John,

I was actually considering remaining in the background for this particular discussion. You make very good points. The (potentially) increased incidence of skin reactions is interesting information that may be worth publishing if you can.

One may want to bear in mind that different applications of skin antisepsis (e.g. blood culture collection, surgical skin prep, vascular catheter insertion) have different functional and physiological characteristics and requirements, and for surgical skin preparation (Jenny’s question), the question of chlorhexidine/alcohol versus povidone-iodine/alcohol is unresolved. Chlorhexidine/alcohol is an excellent choice, but iodine/alcohol should not be discounted for this purpose.

Best regards, Matthias.

—
Matthias Maiwald, MD, FRCPA
Consultant in Microbiology
Adj. Assoc. Prof., Natl. Univ. Singapore
Department of Pathology and Laboratory Medicine
KK Women’s and Children’s Hospital
100 Bukit Timah Road
Singapore 229899
Tel. +65 6394 8725 (Office)
Tel. +65 6394 1389 (Laboratory)
Fax +65 6394 1387

Dear Jenny

The critical point is that when chlorhex is mixed with alcohol , there is no apparent benefit from exceeding 0.5%.

The old literature on 2% C and lines related to an aqueous preparation.
Furthermore, we found an increase in skin reactions to the more concentrated products (went to a poster).

Matthias M will comment no doubt – he has recently published this piece that is of relevance – Maiwald M, Chan ESY. Pitfalls in evidence assessment: the case of chlorhexidine and alcohol in skin antisepsis (Leading Article). J. Antimicrob. Chemother. (2014) Advance Access.
http://jac.oxfordjournals.org/content/early/2014/04/28/jac.dku121.abstract

Kind regards
John

Dr John Ferguson
Infectious Diseases & Microbiology
+61 428 885573

Hi Jenny,
There is lots of supportive evidence for 2%CHG in 70%IPA, particularly for invasive device skin preparation (CVC/PICC/PIVC,ICC/Epidural, etc,etc..)
Here is a link to Dr William Jarvis discussing the differences of various skin preps.
http://www.medscape.com/viewarticle/761489
There is both a video of the discussion..
To cut to the conclusion;
The findings were very interesting. Of greatest importance, the investigators found that all products (0.5% chlorhexidine with ethanol, 1% chlorhexidine with ethanol, and 2% chlorhexidine with isopropyl alcohol) were equally effective. This will be very helpful information when you are trying to select a product for preparation of the insertion site for intravascular catheters or for a preoperative surgical antiseptic. Chlorhexidine is effective, and different concentrations of chlorhexidine are equally effective, with no statistically significant difference in colony counts. All of these products should be equally beneficial to patients in preventing central line-associated bloodstream infections or surgical site infections.

Timothy R. Spencer, RN, APN, DipAppSci, Bach.Health, ICCert.
Clinical Nurse Consultant, Central Venous Access & Parenteral Nutrition Service
Conjoint Lecturer, South West Sydney Clinical School | Faculty of Medicine | University of NSW
President, Australian Vascular Access Society
Dept of Intensive Care, Level 2, Clinical Building, Liverpool Hospital, Elizabeth Street, Liverpool, 2170, NSW, Australia
Tel (+61) 2 8738 3603 | Fax (+61) 2 8738 3551 | Mob +61 (0)409 463 428 | Tim.Spencer@sswahs.nsw.gov.au | Timothy.Spencer@unsw.edu.au

“Be a yardstick of quality. Some people aren’t used to an environment where excellence is expected.” – Steve Jobs
________________________________

Hi all – not sure if this has already been discussed and apologies if it has – one of the orthopaedic surgeons here is requesting Chlorhexidine 2% with 70% alcohol (tinted red) as opposed to the 0.5% with 70% alcohol for skin prep. Firstly, is there an advantage to using the 2% as opposed to the 0.5% and if so would anyone have any literature to support this

Thanks
Jenny McCarthy
Maryvale Private Hospital

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