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“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
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
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
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
ChloraPrep is proven




                          Surgical Site Infections
to reduce the incidence
of SSIs
      15
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
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
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
ChloraPrep delivers best
practice in skin preparation   19




                                    Skin Antiseptic Efficacy
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
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
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
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
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
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




                               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
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
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
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.
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

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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
  • 5. ChloraPrep is proven Surgical Site Infections to reduce the incidence of SSIs 15
  • 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
  • 9. ChloraPrep delivers best practice in skin preparation 19 Skin Antiseptic Efficacy
  • 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
  • 15. The ChloraPrep range ChloraPrep Range
  • 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