“ 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

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

of resident skin bacteria may be found in the top 5 cell layers of the epidermis3

80%

On a single square centimetre of skin, there can be as many as 10 million aerobic bacteria2

The significance of skin dwelling bacteria

1cm

1cm

The risk of contamination

of catheter-related bloodstream infections were caused by contamination with skin flora7

“ In most SSIs, the source of pathogens is the endogenous flora of the patient’s skin”6

60%of all positive blood cultures may be positive due to the presence of contaminants8

50%

Every time a medical procedure breaches the skin, patients are at risk of contamination from their own skin flora5

Surveillance programmes that rely only on inpatient data may hugely underestimate the incidence and cost of SSIs13,14

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 require an average additional stay of 6.5 days and hospital costs are doubled9

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

SSIs are serious and costly

Surgery can open the door for skin flora

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

ChloraPrep is proven to reduce the incidence of SSIs15

Surgical Site Infections

Versus povidone iodine

ChloraPrep reduced SSIs after clean-contaminated surgery by 41% compared with povidone iodine scrub and paint15

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

The number needed to treat with ChloraPrep instead of povidone iodine in order to prevent one case of SSI was approximately 1715

Povidone iodinen=440

Incidence of SSIs (% patients)15

20

15

10

5

0

p=0.004

16.1

9.5

ChloraPrepn=409

Povidone iodine n=440

ChloraPrep n=409

Superficial incisional infection

Deep incisional infection

Incidence of incisional infections(% patients)15

10

8

6

4

2

0

p=0.008

p=0.05

3.0

8.6

4.21.0

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

Incidence of superficial SSI post-discharge (% patients)16

25

20

15

10

5

0

p=0.0502

20.8

0

0.5% chlorhexidine/ 70% isopropyl

alcohol n=24

ChloraPrepn=22

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

Pre-intervention

Following education

programme

Following introduction

of silver-platinum catheters

Following introduction

of ChloraPrep

Rate of catheter related bloodstream infection(mean rate/1000 catheter days)18

20

15

10

5

0

1.6

15.0

6.4

3.34.2

Following introduction

of sterile barrier kits

ChloraPrep provides greater protection against SSIs

ChloraPrep delivers best practice in skin preparation19

Skin Antiseptic Efficacy

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

Basis for effective skin antisepis

1 the type of antiseptic

2 the method of application

Evidence for the choice of antiseptic

ChloraPrep is effective against a broad range of micro-organisms including MRSA, VRE, Clostridium difficile, coagulase negative staphylococci and most viruses and fungi27-29

ChloraPrep has good activity levels within 30 seconds;24 povidone iodine takes 2-3 minutes to reach full effect27

ChloraPrep is effective for at least 48 hours.24,30 0.5% chlorhexidine29 and iodophors have been shown to have a much shorter duration of activity31

Unlike povidone iodine, ChloraPrep is not inactivated in the presence of blood28

Rapid

Persistent

Practical

Optimal agent for pre-surgical skin antisepsis28

ChloraPrep

70% isopropyl alcohol

0.5% aqueous chlorhexidine

2.0% aqueous chlorhexidine

4.0% chlorhexidine

0.5% chlorhexidine + 70% isopropyl alcohol

0.7% iodophor + 74% isopropyl alcohol

0.75% iodine scrub + 1% iodine paint

povidone iodine

ChloraPrep, containing 2% chlorhexidine gluconate and 70% isopropyl alcohol, has demonstrated significantly better antimicrobial activity than:23-26

A quick wipe with an antiseptic solution is insufficient to significantly reduce the bacterial burden prior to puncturing the skin32,33

There is evidence supporting a back and forth scrub movement to reduce microbial counts on the skin36-38

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

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

Spiral wipe method

Reduction of bacterial load following donor arm disinfection(logarithmic reduction)37

0

1

2

3

4

p<0.001

1.31

2.67

Back and forth method

A back and forth prep was used in all the phase III efficacy studies of ChloraPrep applicators34

Evidence for method of application

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

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

0.5% chlorhexidine/ 70% isopropyl alcohol n=24

ChloraPrep n=22

Adhesive dressing component

Mean CFU counts 24-hours after surgery16

20

15

10

5

0

p=0.007

Absorbent dressing component

p=0.02

0.40.6

14.8

4.2

0.7% iodine/ 74% isopropyl alcohol n=40

ChloraPrep n=40

Hallux

Positive culture rates(% patients)25

80

60

40

20

0

p<0.01

Toes

p<0.0565

45

30 23

ChloraPrep is a proven method of skin antisepsis

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

Positive culture rate(% patients)26

40

30

20

10

0

p<0.0001

31%

19%

7%

p<0.01

Povidone-iodinen=50

0.7% iodine/ 74% isopropyl alcohol

n=50

ChloraPrepn=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

Pre-ChloraPrep (0.5% chlorhexidine acetate/isopropyl alcohol wipe)

ChloraPrep

South Midlands South West

London South East

Anglia North West

National failure rate of arm disinfection pre- and post-ChloraPrep introduction (%)19,39

(failure defined as post disinfection count ≥5 CFU/plate)

15

10

5

0

12.8

1.3

5.6

1.2

4.6

0.7

8.5

1.2

9.6

1.83.0

14.5

1.2

14.2

ChloraPrep was introduced as “best practice” throughout the service

ChloraPrep was introduced as “best practice” throughout the service

The ChloraPrep range

ChloraPrep Range

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

of healthcare professionals preferred the ChloraPrep applicator over an iodine preparation because it was easier, faster and less messy to use40

93%

ChloraPrep is the only 2% chlorhexidine/70% isopropyl alcohol licensed for cutaneous antisepsis prior to invasive procedures in the UK41

ChloraPrep has a recognised role in infection prevention

2002 American Academy of Pediatrics

Centers for Disease Control and Prevention

2003 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

ChloraPrep is recommended by, or complies with, the infection control guidelines of many organisations, including:

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

Range of surgical applicatorsLicensed, sterile, single use, ANTT,™ latex free applicators available in the UK

3ml c

lear

10.5

ml c

lear

26m

l cle

ar3m

l tin

ted

10.5

ml t

inte

d26

ml t

inte

d

Coverage area 15 cm x 15 cm

NHS list price per applicator: £0.85(ex. VAT and delivery)

NHS supply chain order code: MRB306

Coverage area 25 cm x 30 cm

NHS list price per applicator: £2.92(ex. VAT and delivery)

NHS supply chain order code: MRB304

Coverage area 50 cm x 50 cm

NHS list price per applicator: £6.50(ex. VAT and delivery)

NHS supply chain order code: MRB305

Coverage area 15 cm x 15 cm

NHS list price per applicator: £0.89(ex. VAT and delivery)

NHS supply chain order code: MRB494

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 50 cm x 50 cm

NHS list price per applicator: £6.83(ex. VAT and delivery)

NHS supply chain order code: MRB496

When using the applicator:

Pinch the lever to release the solution. You will hear a ‘pop’ as the ampoule breaks.

Starting at the incision site, gently press the applicator against the skin until the solution soaks the sponge.

Apply using repeated up and down, back and forth strokes for at least 30 seconds, before working outwards towards the periphery.

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.

1. Pinch 2. Apply 3. Dry

Leave the area to dry completely before applying sterile drapes. Do not blot or wipe away. Discard the applicator after a single use.

Important safety point:Do not drape or use ignition source until the solution has completely dried.

1. House of Commons Public Accounts Committee. Reducing Healthcare Associated Infection in Hospitals in England. 10th November 2009. London: The Stationery Office Limited.

2. Fredericks DN. J Invest Dermatol Symp Proc 2001; 6: 167-9.

3. Hendley JO, Ashe KM. Antimicrob Agents Chemother 1991; 35: 627-31.

4. Milstone AM et al. CID 2008; 46: 274-80.

5. Weaving P et al. J Perioperative Pract 2008; 18: 199-204.

6. Murkin CE. Br J Nurs 2009; 18: 665-9.

7. Safdar N, Maki DG. Int Care Med 2004; 30: 62-7.

8. Calfee DP, Farr BM. J Clin Microbiol 2002; 40: 1660-5.

9. Edwards PS et al. Cochrane DB Syst Rev 2008. DOI:10.1002/14651858.CD003949.pub2

10. Kirkland KB et al. Infect Control Hosp Epidemiol 1999; 20: 725-30.

11. Whitehouse JD et al. Infect Control Hosp Epidemiol 2002; 23: 183-9.

12. Frampton L. Clin Services J 2008; June edition.

13. Tanner J et al. J Hosp Infect 2009; 72: 243-50.

14. Ward VP et al. J Hosp Infect 2008; 70: 166-73.

15. Darouiche R et al. N Engl J Med 2010; 362: 18-26.

16. Casey AL et al. Poster presented at ECCMID, Barcelona, Spain, April 2008.

17. Elliot et al. Vasc Dis Manage 2008; March/April (Suppl.): 3-6.

18. Garcia R et al. Manage Infect Control 2003; 10: 42-9.

19. McDonald CP et al. Vox Sanguinis 2006; 91 (Suppl.3): P-150.

20. Inwood S. Br J Nurs 2007; 16: 1390-4.

21. McGrath DR, McCrory D. Ann R Coll Surg Engl 2005; 87: 366-8.

22. Health Protection Agency. Surveillance of surgical site infection in England. July 2006.

23. Adams D et al. J Hosp Infect 2005; 61: 287-90.

24. Hibbard JS. J Infus Nurs 2005; 28: 194-207.

25. Ostrander RV et al. J Bone Joint Surg Am 2005; 87: 980-5.

26. Saltzman MD et al. J Bone Joint Surg Am 2009; 91: 1949-53.

27. Crosby CT, Mares AK. J Vasc Access Devices 2001; Spring: 26-31.

28. Florman S, Nichols RL. Am J Infect Dis 2007; 3: 51-61.

29. Data on file, CareFusion Ltd.

30. Garcia R et al. Abstracts of the IDSA 40th Annual Meeting 2002; Abs 418.

31. Fletcher N et al. J Bone Joint Surg Am 2007; 89: 1605-18.

32. Royal Marsden Hospital. Clinical Nursing Procedures. Seventh Edition.

33. Weinstein S. Plummer’s Principles and Practices of Intravenous Therapy, 2007. Lippincott, Philadelphia.

34. Richardson D. J Assoc Vasc Access 2006; 11: 215-21.

35. American Association of Critical-Care Nurses. Practice Alert 9/2005. Available at: www.aacn.org/AACN/practiceAlert.nsf/vwdoc/pa2

36. Fortin N. Assoc Periop Reg Nurs J 2006; 84: 11: 745.

37. McDonald CP. Vox Sanguinis 2001; 80: 135-41.

38. Brooks RA et al. Foot Ankle Int 2001; 22: 347-50.

39. McDonald CP et al. Abstracts of the International Society of Blood Transfusion 2007: Poster 254.

40. Barenfanger J et al. J Clin Microbiol 2004; 42: 2216-17.

41. UK PL 31760/0001.

42. www.hpa.org.uk/web/HPAwebFile/HPAweb_C/1194947335427

References:

Prescribing InformationChloraPrep® (PL31760/0002) & ChloraPrep with Tint (PL31760-0001) 2% chlorhexidine gluconate w/v / 70% isopropyl alcohol v/v cutaneous solution. Indication: Disinfection of skin prior to invasive medical procedures. Dosage & administration: ChloraPrep – 0.67ml, 1.5ml, 3ml, 10.5ml, 26ml; ChloraPrep with Tint – 3ml, 10.5ml, 26ml. Volume dependent on invasive procedure being undertaken. Applicator squeezed to break ampoule and release antiseptic solution onto sponge. Solution applied by gently pressing sponge against skin and moving back and forth for 30 seconds. The area covered should be allowed to air dry. Side effects, precautions & contra-indications: Very rarely allergic or skin reactions reported 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

contact with eyes, mucous membranes, middle ear and neural tissue. Should not be used in children under 2 months of age. Solution is flammable. Do not use with ignition sources until dry, do not allow to pool, and remove soaked materials before use. Over-vigorous use on fragile or sensitive skin or repeated use may lead to local skin reactions. At the first sign of local skin reaction, application should be stopped. Per applicator costs (ex VAT) ChloraPrep – 0.67ml (SEPP) - 30p; 1.5ml (FREPP) - 55p; 3ml - 85p; 10.5ml - £2.92; 26ml - £6.50. ChloraPrep with Tint – 3ml - 89p; 10.5ml - £3.07; 26ml - £6.83. Legal category: GSL. Marketing Authorisation Holder: CareFusion UK 244 Ltd, 43 London Road, Reigate, Surrey RH2 9PW, UK. Date of preparation: July 2010.

CHL089a Date of preparation: August 2010

For customer services and all other enquiries: Please telephone: 0800 0437 546 Email: enquiries@chloraprep.co.uk or visit: www.chloraprep.co.uk