1. By Sarah Ewart CHLORHEXIDINE WASH CLOTHS

2. Product Overview Uses Surgical Site Infections When to use the wipes. Competitors Cost analysis Questions and issues that commonly arise. This presentation will cover the following topics: Presentation Layout

3. Product Overview Containing 2% Chlorhexidine Gluconate BP, as well as skin conditioners and moisturisers. The chlorhexidine being the only active ingredient. Designed to be used on skin to kill all the bacterial skin flora. Developed in conjunction with a major University teaching Hospital in London The Royal free. Clinell Chlorhexidine Wash Cloths are a rinse-free, non-alcoholic antiseptic body cleansing solution.

4. Clinell Chlorhexidine Wash Cloths (Wipe Size: 20 x 30cm ) 12 packs of 4 cloths – seen here in desk top tray

5. Product Overview Comes in a desk ready tray of 12 packs Ideal for keeping on the nurses desk during clinic or in ITU 4 large wipes 30 x 20cm and very thick, enough for a whole body cleanse Can be heated for more comfortable bathing Store in a Clinell warmer or heat in a microwave Cares for skin Contains skin conditioners and moisturisers Natural green tea fragrance. > > > > >

6. Chlorhexidine Chlorhexidine is a cationic biguanide which means it is positively charged molecule. This property is what allows it to stick to the skin for long periods and gives the patient a sticky sensation on application. First established as an antimicrobial agent in 1954. It exists as acetate (diacetate), gluconate, and hydrochloride salts. Chlorhexidine is a biocide that is being recommended by many guidelines.

7. Efficacy Broad spectrum activity - Gram positive - Gram negative non-sporing bacteria - Yeast - Selective enveloped viruses such as HIV

8. How it Works Due to the binding of the CHG cationic molecules to the negatively charged components of the bacterial cell wall. Works differently with different concentrations. Exerts a bacteriostatic effect by causing an alteration of the bacterial cell osmotic equilibrium resulting in leakage of potassium and phosphorus, inhibiting growth. At low concentrations Rapidly bactericidal, the result of precipitation of the bacterial cell cytoplasmic contents. At high concentrations

9. Uses Two main uses: Bed bathing of ITU patients This should be done on a daily basis. This will reduce the incidence of blood stream infections (BSIs). Presurgical patient bathing This should be done the morning or the night before the surgery. This will reduce the incidence of surgical site infections (SSIs).

10. How it Works The chlorhexidine will kill the bacterial skin flora. It will be effective for many hours as it sticks to the skin for over 6 hours giving a protective coating barrier effect. Should be used with care being taken to avoid the eyes and areas of disrupted skin integrity. Because it is cationic (positively charged) it sticks to the skin leaving a residual coating of chlorhexidine.

11. ITU Patients Intensive Therapy Unit (ITU) patients have many invasive procedures per day with many skin penetrations occurring daily. Therefore they are at a higher risk of blood stream infections from their own skin flora. By reducing patient’s skin microbes such as: MRSA, VRE, Acinetobacter etc. It prevents these microbes being introduced by the needle into the bloodstream. Therefore this product will reduce the incidence of blood stream infection (BSIs).

12. Surgical Site Infections (SSIs) A surgical site infection (SSI) is a type of healthcare-associated infection in which a wound infection occurs after an invasive (surgical) procedure. At least 5% of patients undergoing a surgical procedure develop an SSI. SSIs have been shown to compose up to 20% of all of healthcare-associated infections.

13. An SSI may range from a spontaneously limited wound discharge within 7–10 days after an operation to a life-threatening postoperative complication, such as a sternal infection after open heart surgery. Most SSIs are caused by contamination of an incision with microorganisms from the patient’s own body during surgery. Surgical Site Infections (SSIs)

14. Infection caused by microorganisms from an outside source following surgery is less common. The majority of SSIs are preventable. Measures can be taken in the pre-, intra- and postoperative phases of care to reduce risk of infection. They are associated with considerable morbidity and extended hospital stay. Considerable financial burden to healthcare providers. Patients who develop an SSI are also "twice as likely to die." > > > > >

15. Source of Surgical Site Infections (SSIs) Most SSIs come from bacteria already found on a patient's skin (skin flora). Multi-drug resistant organisms such as MRSA, VRE, and Acinetobacter are just some of the SSI-causing pathogens that can be found on a patient's skin. Chlorhexidine will eradicate all bacteria on a patients skin (unless resistance has occurred).

16. MRSA and SSIs Staphylococcus aureus is recognised as a major cause of SSIs. S. aureus bacteria accounts for 44% of all SSIs. And this means just over a quarter of all SSIs (26%) were caused by MRSA. Of all SSIs caused by S. aureus, 60% were methicillin-resistant (MRSA).

17. How to Reduce SSIs Preoperative phase Intraoperative phase Postoperative phase > > >

18. Preoperative Phase NICE guidelines (UK) Advise patients to shower or have a bath (or help patients to shower, bath or bed bath), either the night before the operative day CDC guidelines (USA) Require patients to shower or bathe with an antiseptic agent on at least the night before the operative day.

19. Comfort Vs. Clinell 4 Wipes Size 30x20cm – 66% bigger 2 or 6 Wipes Size 19x19cm Cost in the UK £0.93 (£0.23 per wipe) Cost in the UK (2 wipe pack) £1.49 (£0.74 per wipe) Cost in the UK (6 wipe pack) £2.88 (£0.48 per wipe) Comfort Clinell

20. Summary Clinell has 66% larger wipes than Comfort. Clinell is 52% cheaper per wipe than the cheapest Comfort wipe (6 pack). Clinell is 69% cheaper per wipe than the 2 pack Comfort. These prices are based on UK hospital purchase prices. > > > >

21. 4% CHG Bottles Many hospitals use these for washing patients. Give 1 bottle to each patient Use the bottle on the ward/ITU Bottle on its own more expensive £1.18 compared to £0.93 for Clinell. Compliance is less with bottles – wipes much easier. Papers show coverage with bottle wash not great with large gaps evident. Dilution issue. In hospital wipes offer large cost saving due to quicker bathing process – see cost comparison sheet.

22. Questions and Issues Show them the journals which you can get on request from GAMA. The data is mainly from the USA and quite a bit has been published on SAGE Comfort wipes. In effect we are a cheaper improved version of SAGE. We also have data confirming that the formulations in Clinell and SAGE are identical. Is there any evidence it works? Q

23. Questions and Issues Most of the evidence published is on 2% CHG look at the 2% CHG & 70% IPA wipes in EPIC guidelines. Also some journals have shown cloths containing 2% CHG actually leave more residual CHG on skin than 4% bottles. Also 4% CHG bottles applications have shown gaps in coverage – using a cloth these gaps are absent. Show journal by Edmiston, American College Surgeons, 2008. Your cloths only have 2% the bottles are 4% - surely yours is not as effective? Q

24. Questions and Issues CHG surface activity is enhanced following multiple applications – cumulative effect. In the USA most practitioners recommend 2 – 5 separate applications before surgery. Why not just wash on the morning of surgery, what is the point of also doing it the night before? Q

25. Questions and Issues One of the most important aspects about using the wipes is they need to used be used correctly and patient compliance has to be high. We provide custom leaflets to be given to the patient in preadmission clinic to help with compliance and correct procedure. Do you offer any literature to go with the product Q

26. Questions and Issues Some patients can be allergic, (as any disinfectants such as alcohol), but it is rare – discontinue use if occurs. Understand that sensitivity is not the same as Resistance: Sensitivity is the patient having an allergic Reaction to the chlorhexidine. Resistance is the bacteria being able to survive Chlorhexidine application. What about CHG sensitivity? Q

27. Questions and Issues Our wipes are 30x20cm much larger than sage and an independent laboratory has said ‘In practicable terms, both the Clinell & Comfort Wash Cloths should be considered essentially equivalent and Interchangeable. You have 4 wipes but the studies were done ton the sage 6 pack? Q

28. Questions and Issues CHG is poorly absorbed through intact skin in adults but can be absorbed in neonates through to young adults (3 months – 17 years). Recent study of 100 neonatal ICU in the US found that CHG is frequently used (>50%) for CVC, PICC, Umbilical line insertions, and CVC maintenance and less frequently (<10%) for MRSA decolonisation and routine bathing. Although used safely across USA CHG is not currently recommended by FDA in infants less than 2 months of age. Can it be used in neonates? Q

29. Questions and Issues Resistance to chlorhexidine among gram-positive bacterial species is rather uncommon. Gram positive cause the majority of Hospital Acquired Infections. Most studies showing resistance have use minimum inhibitory concentrations and not the high level concentration in our product. Important to note that a reduced susceptibility to CHG does not translate into diminished antimicrobial effectiveness when the biocide is used at the appropriate concentration. What about CHG resistance? Q

30. Questions?