Surgical Sales Aid | ChloraPrep UK Infection Prevention & Control


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Surgical Sales Aid | ChloraPrep UK Infection Prevention & Control

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Surgical Sales Aid | ChloraPrep UK Infection Prevention & Control

  1. 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 20091Prescribing information can be found on the back cover
  2. 2. The significanceof skin dwelling bacteria1cm 1cmOn 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 epidermis3Historically, infection prevention measures have focused on asepsisof healthcare providers and the environment4Emerging evidence about the role played by the patient’s own skinis changing the paradigm4
  3. 3. The riskof contaminationEvery 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 positiveinfections were caused by due to the presence of contaminants8contamination with skin flora7
  4. 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 SSIs1SSIs areserious SSIs require an average additional stay of 6.5 days and hospital costs are doubled9and 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. 5. ChloraPrep is proven Surgical Site Infectionsto reduce the incidenceof SSIs 15
  6. 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=0.004Incidence 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=0.008Incidence of 8incisional 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. 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 25Incidence of p=0.0502superficial SSIpost-discharge 20 20.8(% patients)16 15 10 5 0 0 0.5% chlorhexidine/ ChloraPrep 70% isopropyl n=22 alcohol n=24
  8. 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 20Rate of catheterrelated bloodstreaminfection 15(mean rate/1000 15.0catheter 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. 9. ChloraPrep delivers bestpractice in skin preparation 19 Skin Antiseptic Efficacy
  10. 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:91 2the type the methodof antiseptic of application
  11. 11. Evidence for thechoice of antisepticChloraPrep, containing 70% isopropyl alcohol2% chlorhexidine 0.5% aqueous chlorhexidinegluconate and 70% 2.0% aqueous chlorhexidineisopropyl alcohol, 4.0% chlorhexidinehas demonstrated 0.5% chlorhexidine + 70% isopropyl alcoholsignificantly better 0.7% iodophor + 74% isopropyl alcoholantimicrobial activity 0.75% iodine scrub + 1% iodine paintthan:23-26 povidone iodineChloraPrep is effective against a broad range of micro-organismsincluding MRSA, VRE, Clostridium difficile, coagulase negativestaphylococci and most viruses and fungi27-29Optimal agent ChloraPrepfor pre-surgicalskin antisepsis28 ChloraPrep has good activity levels within 30 seconds;24Rapid povidone iodine takes 2-3 minutes to reach full effect27 ChloraPrep is effective for at least 48 hours.24,30Persistent 0.5% chlorhexidine29 and iodophors have been shown to have a much shorter duration of activity 31 Unlike povidone iodine, ChloraPrep is not inactivated inPractical the presence of blood28
  12. 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 0Reduction ofbacterial load 1 1.31following donorarm disinfection 2(logarithmic 2.67reduction)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. 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 20Mean CFU counts p=0.00724-hours after 15surgery16 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<0.01Positive 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. 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<0.0001Positive 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 15National failure rate 14.5 14.2 12.8of arm disinfectionpre- and post- 10 9.6ChloraPrep 8.5introduction (%)19,39 5 5.6(failure defined as post 4.6disinfection count ≥5 3.0CFU/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. 15. The ChloraPrep range ChloraPrep Range
  16. 16. ChloraPrep is an easy toapply, 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 use40ChloraPrep is the only 2% chlorhexidine/70% isopropyl alcohol licensed for cutaneousantisepsis prior to invasive procedures in the UK41
  17. 17. ChloraPrep has a recognised role in infection preventionChloraPrep is 2002recommended by, American Academy of Pediatricsor complies with, Centers for Disease Control and Preventionthe infection controlguidelines of many 2003organisations, 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. 18. Range of surgical applicators Licensed, sterile, single use, ANTT,™ latex free applicators available in the UK Coverage area3ml clear 15 cm x 15 cm NHS list price per applicator: £0.85 (ex. VAT and delivery) NHS supply chain order code: MRB306 Coverage area10.5ml clear 25 cm x 30 cm NHS list price per applicator: £2.92 (ex. VAT and delivery) NHS supply chain order code: MRB304 Coverage area26ml clear 50 cm x 50 cm NHS list price per applicator: £6.50 (ex. VAT and delivery) NHS supply chain order code: MRB305 Coverage area3ml tinted 15 cm x 15 cm NHS list price per applicator: £0.89 (ex. VAT and delivery) NHS supply chain order code: MRB49410.5ml 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 area26ml tinted 50 cm x 50 cm NHS list price per applicator: £6.83 (ex. VAT and delivery) NHS supply chain order code: MRB496
  19. 19. When using the applicator: 1. Pinch 2. Apply 3. DryPinch the lever to release Starting at the incision site, Leave the area to drythe solution. You will gently press the applicator completely beforehear 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. 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: 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. customer services and all other enquiries:Please telephone: 0800 0437 546Email: visit: Information contact with eyes, mucous membranes, middle ear and neural tissue. Should not be used inChloraPrep® (PL31760/0002) & ChloraPrep with Tint (PL31760-0001) 2% chlorhexidine children under 2 months of age. Solution is flammable. Do not use with ignition sources untilgluconate 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 onskin 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 of1.5ml, 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) ChloraPrepinvasive 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, Surreyeffects, 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 withknown hypersensitivity to these constituents. For external use only on intact skin. Avoid CHL089a Date of preparation: August 2010