The Public Accounts Committee report from November 10, 2009 states that while people naturally carry bacteria on their skin, hospitals should not tolerate infections that could have been avoided. Historically infection prevention has focused on healthcare provider asepsis and the environment, but the patient's own skin is now recognized as playing an important role in potential contamination. Every medical procedure that breaches the skin puts patients at risk of contamination from their endogenous skin flora.
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The significance of skin dwelling bacteria in preventing surgical site infections
1. “Whilst every person carries millions of bacteria
on their skin, hospitals should not be tolerant
of any infections that could be avoided”
The Public Accounts Committee, 10th November 20091
Prescribing information can be found on the back cover
2. The significance
of skin dwelling bacteria
1cm
1cm
On a single square centimetre of skin,
there can be as many as 10 million aerobic bacteria2
80%
of resident skin bacteria may be found
in the top 5 cell layers of the epidermis3
Historically, infection prevention measures have focused on asepsis
of healthcare providers and the environment4
Emerging evidence about the role played by the patient’s own skin
is changing the paradigm4
3. The risk
of contamination
Every time a medical procedure breaches the skin,
patients are at risk of contamination from their own skin flora5
“In most SSIs, the
source of pathogens
is the endogenous
flora of the patient’s
skin”6
60% 50%
of catheter-related bloodstream of all positive blood cultures may be positive
infections were caused by due to the presence of contaminants8
contamination with skin flora7
4. Surgery can open
the door for skin flora
SSIs are frequently caused by a patient’s own skin flora, the
surgical incision providing a portal of entry for micro-organisms4,5
1 in 7 of all hospital-acquired infections are SSIs1
SSIs are
serious SSIs require an average additional stay of 6.5 days and hospital
costs are doubled9
and costly
Patients with SSIs are 60% more likely to spend time in ICU,
5 times more likely to be readmitted to hospital and twice as likely
to die10
Health-related quality of life may be significantly impaired11
At one London Trust, the annual cost associated with SSIs for just
one surgical core area (coronary artery bypass graft) amounted
to around £500,00012
Surveillance programmes that rely only on inpatient data may hugely underestimate
the incidence and cost of SSIs13,14
6. ChloraPrep provides greater
protection against SSIs
Versus povidone iodine
ChloraPrep reduced SSIs after clean-contaminated surgery by 41%
compared with povidone iodine scrub and paint15
20
p=0.004
Incidence of SSIs
15
(% patients)15 16.1
10
9.5
5
0
Povidone iodine ChloraPrep
n=440 n=409
When comparing specific types of infection, ChloraPrep was significantly
more protective than povidone iodine against both superficial incisional
infections (52% reduction) and deep incisional infections (67% reduction)15
10
p=0.008
Incidence of 8
incisional infections 8.6
6
(% patients)15
4 p=0.05
4.2
2
3.0 1.0
0
Povidone iodine n=440 Superficial incisional Deep incisional
ChloraPrep n=409 infection infection
The number needed to treat with ChloraPrep instead of povidone iodine in order
to prevent one case of SSI was approximately 1715
7. ChloraPrep provides greater
protection against SSIs
Versus 0.5% chlorhexidine/70% isopropyl alcohol
Rates of SSI following saphenous vein harvest as high as 1 in 5 patients
have been reported16
Interim results from a UK, prospective, randomised, coronary artery bypass
surgery study support ChloraPrep’s potential to reduce the risk of SSIs16
At 30 days post-discharge, no ChloraPrep patient had
developed an SSI following saphenectomy16
25
Incidence of p=0.0502
superficial SSI
post-discharge 20
20.8
(% patients)16
15
10
5
0
0
0.5% chlorhexidine/ ChloraPrep
70% isopropyl n=22
alcohol
n=24
8. ChloraPrep provides greater
protection against SSIs
In minimally invasive surgery
Intravascular catheter placement is an appropriate model for minimally invasive surgery17
ChloraPrep reduced CVC-related bloodstream infections
in a university hospital by 62%18
20
Rate of catheter
related bloodstream
infection 15
(mean rate/1000 15.0
catheter days)18
10
5 6.4
4.2 1.6
3.3
0
Pre- Following Following Following Following
intervention education introduction introduction introduction
programme of silver- of sterile of ChloraPrep
platinum barrier kits
catheters
10. Basis for effective
skin antisepis
The array of skin antisepsis options available contributes to wide variation in the
methods used between, and even within, units20,21
– there is also wide variation in SSI rates between hospitals14,22
“ . . . infection control and prevention has been cited as the
rationale for numerous rituals carried out despite the lack of
evidence that such actions reduce the risk of infection”5
There are two factors contributing to the effectiveness of antiseptic skin preparation:9
1 2
the type the method
of antiseptic of application
11. Evidence for the
choice of antiseptic
ChloraPrep, containing 70% isopropyl alcohol
2% chlorhexidine 0.5% aqueous chlorhexidine
gluconate and 70% 2.0% aqueous chlorhexidine
isopropyl alcohol, 4.0% chlorhexidine
has demonstrated 0.5% chlorhexidine + 70% isopropyl alcohol
significantly better 0.7% iodophor + 74% isopropyl alcohol
antimicrobial activity 0.75% iodine scrub + 1% iodine paint
than:23-26 povidone iodine
ChloraPrep is effective against a broad range of micro-organisms
including MRSA, VRE, Clostridium difficile, coagulase negative
staphylococci and most viruses and fungi27-29
Optimal agent ChloraPrep
for pre-surgical
skin antisepsis28
ChloraPrep has good activity levels within 30 seconds;24
Rapid povidone iodine takes 2-3 minutes to reach full effect27
ChloraPrep is effective for at least 48 hours.24,30
Persistent 0.5% chlorhexidine29 and iodophors have been shown to
have a much shorter duration of activity 31
Unlike povidone iodine, ChloraPrep is not inactivated in
Practical the presence of blood28
12. Evidence for
method of application
While sufficient solution should be applied to ensure uniform
distribution of the antiseptic,6 applying antiseptic as a spray
does no more than soak an area – no significant cleaning
action occurs20
A quick wipe with an antiseptic solution is insufficient to significantly reduce the
bacterial burden prior to puncturing the skin32,33
Concentric prepping is not evidence based34-36
– a circular pattern in the same direction may not allow
penetration into the cracks and fissures of the skin27
There is evidence supporting a back and forth scrub movement to reduce microbial
counts on the skin36-38
0
Reduction of
bacterial load 1 1.31
following donor
arm disinfection 2
(logarithmic 2.67
reduction)37 3
p<0.001
4
Spiral wipe Back and forth
method method
A back and forth prep was used in all the phase III
efficacy studies of ChloraPrep applicators34
13. ChloraPrep is a proven
method of skin antisepsis
CABG
With ChloraPrep, dressings removed 24 hours after surgery contained a significantly
lower number of micro-organisms than those recovered from patients whose skin
had been prepped with 0.5% chlorhexidine/70% isopropyl alcohol16
20
Mean CFU counts p=0.007
24-hours after 15
surgery16 14.8
10
p=0.02
5
0.6 4.2 0.4
0
0.5% chlorhexidine/ Adhesive dressing Absorbent dressing
70% isopropyl alcohol n=24
component component
ChloraPrep n=22
Foot and ankle surgery
The foot provides a unique environment for the growth of numerous bacterial species25
ChloraPrep halved the number of positive cultures from the halluces/toes compared
with an iodine/alcohol preparation25
80
p<0.01
Positive culture rates
(% patients)25 60
65 p<0.05
40
45
20 30 23
0
0.7% iodine/ Hallux Toes
74% isopropyl alcohol n=40
ChloraPrep n=40
14. ChloraPrep is a proven
method of skin antisepsis
Shoulder surgery
ChloraPrep was more effective than iodophor/alcohol and povidone-iodine
at eradicating bacteria from the shoulder region prior to surgery26
40
p<0.0001
Positive culture rate p<0.01
(% patients)26 30
31%
20
19%
10
0
7%
Povidone-iodine 0.7% iodine/ ChloraPrep
n=50 74% isopropyl alcohol n=50
n=50
National Blood Service
ChloraPrep was evaluated by the National Blood Service in an effort to reduce
the risk of bacterial transfusion-transmitted infection19,39
– ChloraPrep was 10 times more efficient than 0.5% chlorhexidine/isopropyl
alcohol wipes in arm disinfection
15
National failure rate 14.5 14.2
12.8
of arm disinfection
pre- and post- 10
9.6
ChloraPrep 8.5
introduction (%)19,39 5 5.6
(failure defined as post 4.6
disinfection count ≥5 3.0
CFU/plate) 1.3
0.7 1.8
1.2 1.2 1.2
0
Pre-ChloraPrep South Midlands South London South Anglia North
(0.5% chlorhexidine acetate/ West East West
isopropyl alcohol wipe)
ChloraPrep
ChloraPrep was introduced as “best practice” throughout the service
16. ChloraPrep is an easy to
apply, sterile, skin antisepsis system
Sterile solution is maintained in a glass ampoule prior to
activation, obviating concerns about contamination37
In line with ANTT,™ the operator’s hands do not come into
contact with the patient’s skin, preventing cross contamination37
The foam sponge controls flow to prevent splashing/pooling
while gently helping to expose bacteria in the lower cell layers
93%
of healthcare professionals preferred the ChloraPrep
applicator over an iodine preparation because it was
easier, faster and less messy to use40
ChloraPrep is the only 2% chlorhexidine/70% isopropyl alcohol licensed for cutaneous
antisepsis prior to invasive procedures in the UK41
17. ChloraPrep has a recognised
role in infection prevention
ChloraPrep is 2002
recommended by, American Academy of Pediatrics
or complies with,
Centers for Disease Control and Prevention
the infection control
guidelines of many 2003
organisations, including: National Institute for Health and Clinical Excellence
Society for Interventional Radiology
2005
Department of Health Saving Lives Delivery Programme
Scottish Intensive Care Society Audit Group (SICSAG)
American Association of Critical-Care Nurses
2006
National Blood Service
National Kidney Foundation
2007
epic2 Guidelines
2008
Infectious Disease Society of America
The 2% chlorhexidine concentration is now proven in 39 outcome studies and
recommended in 11 evidence-based guidelines
On the basis of evidence, in 2005 the Health Protection Agency’s Rapid Review Panel gave
ChloraPrep its highest recommendation (Recommendation 1):42
“Basic research and development, validation and recent in
use evaluations have shown benefits that should be
available to NHS bodies”42
18. Range of surgical applicators
Licensed, sterile, single use, ANTT,™ latex free applicators available in the UK
Coverage area
3ml clear
15 cm x 15 cm
NHS list price per applicator: £0.85
(ex. VAT and delivery)
NHS supply chain order code: MRB306
Coverage area
10.5ml clear
25 cm x 30 cm
NHS list price per applicator: £2.92
(ex. VAT and delivery)
NHS supply chain order code: MRB304
Coverage area
26ml clear
50 cm x 50 cm
NHS list price per applicator: £6.50
(ex. VAT and delivery)
NHS supply chain order code: MRB305
Coverage area
3ml tinted
15 cm x 15 cm
NHS list price per applicator: £0.89
(ex. VAT and delivery)
NHS supply chain order code: MRB494
10.5ml tinted
Coverage area
25 cm x 30 cm
NHS list price per applicator: £3.07
(ex. VAT and delivery)
NHS supply chain order code: MRB495
Coverage area
26ml tinted
50 cm x 50 cm
NHS list price per applicator: £6.83
(ex. VAT and delivery)
NHS supply chain order code: MRB496
19. When using the applicator:
1. Pinch 2. Apply 3. Dry
Pinch the lever to release Starting at the incision site, Leave the area to dry
the solution. You will gently press the applicator completely before
hear a ‘pop’ as the against the skin until the applying sterile drapes.
ampoule breaks. solution soaks the sponge. Do not blot or wipe away.
Discard the applicator
Apply using repeated after a single use.
up and down, back and
forth strokes for at least Important safety point:
30 seconds, before Do not drape or use
working outwards towards ignition source until
the periphery. the solution has
completely dried.
The 26ml applicator
contains two swabs.
Where applicable, the
swabs can be moistened
by pressing against the
soaked sponge and then
used to clean the umbilicus.
20. References:
1. House of Commons Public Accounts Committee. Reducing Healthcare 22. Health Protection Agency. Surveillance of surgical site infection in
Associated Infection in Hospitals in England. 10th November 2009. England. July 2006.
London: The Stationery Office Limited. 23. Adams D et al. J Hosp Infect 2005; 61: 287-90.
2. Fredericks DN. J Invest Dermatol Symp Proc 2001; 6: 167-9. 24. Hibbard JS. J Infus Nurs 2005; 28: 194-207.
3. Hendley JO, Ashe KM. Antimicrob Agents Chemother 1991; 35: 25. Ostrander RV et al. J Bone Joint Surg Am 2005; 87: 980-5.
627-31.
26. Saltzman MD et al. J Bone Joint Surg Am 2009; 91: 1949-53.
4. Milstone AM et al. CID 2008; 46: 274-80.
27. Crosby CT, Mares AK. J Vasc Access Devices 2001; Spring: 26-31.
5. Weaving P et al. J Perioperative Pract 2008; 18: 199-204.
28. Florman S, Nichols RL. Am J Infect Dis 2007; 3: 51-61.
6. Murkin CE. Br J Nurs 2009; 18: 665-9.
29. Data on file, CareFusion Ltd.
7. Safdar N, Maki DG. Int Care Med 2004; 30: 62-7.
30. Garcia R et al. Abstracts of the IDSA 40th Annual Meeting 2002;
8. Calfee DP, Farr BM. J Clin Microbiol 2002; 40: 1660-5. Abs 418.
9. Edwards PS et al. Cochrane DB Syst Rev 2008. 31. Fletcher N et al. J Bone Joint Surg Am 2007; 89: 1605-18.
DOI:10.1002/14651858.CD003949.pub2
32. Royal Marsden Hospital. Clinical Nursing Procedures. Seventh Edition.
10. Kirkland KB et al. Infect Control Hosp Epidemiol 1999; 20: 725-30.
33. Weinstein S. Plummer’s Principles and Practices of Intravenous
11. Whitehouse JD et al. Infect Control Hosp Epidemiol 2002; 23: 183-9. Therapy, 2007. Lippincott, Philadelphia.
12. Frampton L. Clin Services J 2008; June edition. 34. Richardson D. J Assoc Vasc Access 2006; 11: 215-21.
13. Tanner J et al. J Hosp Infect 2009; 72: 243-50. 35. American Association of Critical-Care Nurses. Practice Alert 9/2005.
14. Ward VP et al. J Hosp Infect 2008; 70: 166-73. Available at: www.aacn.org/AACN/practiceAlert.nsf/vwdoc/pa2
15. Darouiche R et al. N Engl J Med 2010; 362: 18-26. 36. Fortin N. Assoc Periop Reg Nurs J 2006; 84: 11: 745.
16. Casey AL et al. Poster presented at ECCMID, Barcelona, Spain, 37. McDonald CP. Vox Sanguinis 2001; 80: 135-41.
April 2008. 38. Brooks RA et al. Foot Ankle Int 2001; 22: 347-50.
17. Elliot et al. Vasc Dis Manage 2008; March/April (Suppl.): 3-6. 39. McDonald CP et al. Abstracts of the International Society of Blood
18. Garcia R et al. Manage Infect Control 2003; 10: 42-9. Transfusion 2007: Poster 254.
19. McDonald CP et al. Vox Sanguinis 2006; 91 (Suppl.3): P-150. 40. Barenfanger J et al. J Clin Microbiol 2004; 42: 2216-17.
20. Inwood S. Br J Nurs 2007; 16: 1390-4. 41. UK PL 31760/0001.
21. McGrath DR, McCrory D. Ann R Coll Surg Engl 2005; 87: 366-8. 42. www.hpa.org.uk/web/HPAwebFile/HPAweb_C/1194947335427
For customer services and all other enquiries:
Please telephone: 0800 0437 546
Email: enquiries@chloraprep.co.uk
or visit: www.chloraprep.co.uk
Prescribing Information contact with eyes, mucous membranes, middle ear and neural tissue. Should not be used in
ChloraPrep® (PL31760/0002) & ChloraPrep with Tint (PL31760-0001) 2% chlorhexidine children under 2 months of age. Solution is flammable. Do not use with ignition sources until
gluconate w/v / 70% isopropyl alcohol v/v cutaneous solution. Indication: Disinfection of dry, do not allow to pool, and remove soaked materials before use. Over-vigorous use on
skin prior to invasive medical procedures. Dosage & administration: ChloraPrep – 0.67ml, fragile or sensitive skin or repeated use may lead to local skin reactions. At the first sign of
1.5ml, 3ml, 10.5ml, 26ml; ChloraPrep with Tint – 3ml, 10.5ml, 26ml. Volume dependent on local skin reaction, application should be stopped. Per applicator costs (ex VAT) ChloraPrep
invasive procedure being undertaken. Applicator squeezed to break ampoule and release – 0.67ml (SEPP) - 30p; 1.5ml (FREPP) - 55p; 3ml - 85p; 10.5ml - £2.92; 26ml - £6.50.
antiseptic solution onto sponge. Solution applied by gently pressing sponge against skin and ChloraPrep with Tint – 3ml - 89p; 10.5ml - £3.07; 26ml - £6.83. Legal category: GSL.
moving back and forth for 30 seconds. The area covered should be allowed to air dry. Side Marketing Authorisation Holder: CareFusion UK 244 Ltd, 43 London Road, Reigate, Surrey
effects, precautions & contra-indications: Very rarely allergic or skin reactions reported RH2 9PW, UK. Date of preparation: July 2010.
with chlorhexidine, isopropyl alcohol and Sunset Yellow. Contra-indicated for patients with
known hypersensitivity to these constituents. For external use only on intact skin. Avoid CHL089a Date of preparation: August 2010