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Chlorhexidine-alcohol
versus povidone iodine
for surgical-site antisepsis
Darouiche RO, Wall MJ, Itani KMF, Otterson MF, Webb AL, Carrick MM, Miller HJ,
Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH


New England Journal of Medicine 2010; 362: 18-26




Background                The patients skin is a major source of pathogens causing surgical-site infection (SSI);
                          optimisation of pre-operative skin antisepsis may decrease post-operative infections

                          No published randomised studies have, however, compared the effect of one
                          antiseptic preparation with another on the incidence of SSIs

                          Since Centers for Disease Control and Prevention guidelines recommend the use of
                          2% chlorhexidine-containing products for cleansing the site of insertion of vascular
                          catheters, a similar approach for pre-operative skin antisepsis could also be optimal




Aim                       To compare the efficacy of ChloraPrep (2% chlorhexidine gluconate / 70% isopropyl
                          alcohol) applicators versus povidone iodine scrub and paint in preventing SSIs




Methods                   Prospective, randomised, multicentre study of 849 adult patients undergoing clean-
                          contaminated surgery (gastrointestinal, thoracic, gynaecological or urological)

                          Standard-of-care preventive measures (such as administering systemic prophylactic
                          antibiotics) were universally enforced

                          Pre-operative antiseptic cleansing of the skin was carried out using either ChloraPrep
                          applicators or povidone iodine scrub and paint

                          The primary endpoint was the occurrence of any SSI within 30 days of surgery
Results                          ChloraPrep reduced SSIs after clean-contaminated surgery by 41% as compared with
                                 povidone iodine scrub and paint




                            20
Incidence of SSIs
(% patients)                                                      p=0.004



                            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)


                            10

Incidence of                                                                              p=0.008
incisional infections
(% patients)                 8                                                      8.6
                                                                                         p=0.49

                             6




                             4
                                                    p=0.05                                          4.2

                             2
                                              3.0


                             0
                                                             1.0
    Povidone iodine n=440                       Deep incisional                          Superficial
    ChloraPrep n=409                              infection                         incisional infection
Lower rates of SSI were observed in the ChloraPrep group than in the povidone iodine
                           group for each of the seven types of operations studied



                      35

Incidence of SSIs
by surgery type (%)   30
                                                              29.4


                      25



                                22.0
                      20
                                                                              20.7



                      15
                                       15.1


                      10                                                             11.5

                                                9.3                  9.8
                                                                                                                        8.6
                                                                                             7.0
                       5
                                                      4.6                                          4.5
                                                                                                            2.5   0           0
                       0


   Povidone iodine             n=191 n=186     n=54 n=44       n=34 n=41     n=29 n=26       n=57 n=44      n=40 n=42   n=35 n=26

   ChloraPrep                   Colorectal       Biliary        Small         Gastro-       Thoracic     Gynaecologic   Urologic
                                                              intestinal    esophogeal




                           The number needed to treat with ChloraPrep instead of povidone iodine in order to
                           prevent one case of SSI was approximately 17




Conclusions                ChloraPrep is superior to povidone iodine in preventing wound infections after
                           clean-contaminated surgery

                           The superior protection afforded by ChloraPrep may be attributed to the rapid,
                           residual and persistent antimicrobial activity despite exposure to bodily fluids of
                           the combination of 2% chlorhexidine and alcohol
Prescribing Information                                                                                  Avoid contact with eyes, mucous membranes, middle ear and neural tissue. Should not be used in
ChloraPrep速 (PL31760/0002) & ChloraPrep with Tint (PL31760-0001) 2% chlorhexidine gluconate              children under 2 months of age. Solution is flammable. Do not use with ignition sources until dry, do
w/v / 70% isopropyl alcohol v/v cutaneous solution. Indication: Disinfection of skin prior to invasive   not allow to pool, and remove soaked materials before use. Over-vigorous use on fragile or sensitive
medical procedures. Dosage & administration: ChloraPrep  0.67ml, 1.5ml, 3ml, 10.5ml, 26ml;              skin or repeated use may lead to local skin reactions. At the first sign of local skin reaction, application
ChloraPrep with Tint  3ml, 10.5ml, 26ml. Volume dependent on invasive procedure being undertaken.       should be stopped. Per applicator costs (ex VAT) ChloraPrep  0.67ml (SEPP) - 30p; 1.5ml (FREPP)
Applicator squeezed to break ampoule and release antiseptic solution onto sponge. Solution applied       - 55p; 3ml - 85p; 10.5ml - 贈2.92; 26ml - 贈6.50. ChloraPrep with Tint  3ml - 89p; 10.5ml - 贈3.07; 26ml
by gently pressing sponge against skin and moving back and forth for 30 seconds. The area covered        - 贈6.83. Legal category: GSL. Marketing Authorisation Holder: CareFusion UK 244 Ltd, 43
should be allowed to air dry. Side effects, precautions & contra-indications: Very rarely allergic       London Road, Reigate, Surrey RH2 9PW, UK. Date of preparation: July 2010.
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.    CHL101a Date of preparation: August 2010

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Darouiche Clinical Summary | ChloraPrep UK Infection Prevention & Control

  • 1. Chlorhexidine-alcohol versus povidone iodine for surgical-site antisepsis Darouiche RO, Wall MJ, Itani KMF, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH New England Journal of Medicine 2010; 362: 18-26 Background The patients skin is a major source of pathogens causing surgical-site infection (SSI); optimisation of pre-operative skin antisepsis may decrease post-operative infections No published randomised studies have, however, compared the effect of one antiseptic preparation with another on the incidence of SSIs Since Centers for Disease Control and Prevention guidelines recommend the use of 2% chlorhexidine-containing products for cleansing the site of insertion of vascular catheters, a similar approach for pre-operative skin antisepsis could also be optimal Aim To compare the efficacy of ChloraPrep (2% chlorhexidine gluconate / 70% isopropyl alcohol) applicators versus povidone iodine scrub and paint in preventing SSIs Methods Prospective, randomised, multicentre study of 849 adult patients undergoing clean- contaminated surgery (gastrointestinal, thoracic, gynaecological or urological) Standard-of-care preventive measures (such as administering systemic prophylactic antibiotics) were universally enforced Pre-operative antiseptic cleansing of the skin was carried out using either ChloraPrep applicators or povidone iodine scrub and paint The primary endpoint was the occurrence of any SSI within 30 days of surgery
  • 2. Results ChloraPrep reduced SSIs after clean-contaminated surgery by 41% as compared with povidone iodine scrub and paint 20 Incidence of SSIs (% patients) p=0.004 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) 10 Incidence of p=0.008 incisional infections (% patients) 8 8.6 p=0.49 6 4 p=0.05 4.2 2 3.0 0 1.0 Povidone iodine n=440 Deep incisional Superficial ChloraPrep n=409 infection incisional infection
  • 3. Lower rates of SSI were observed in the ChloraPrep group than in the povidone iodine group for each of the seven types of operations studied 35 Incidence of SSIs by surgery type (%) 30 29.4 25 22.0 20 20.7 15 15.1 10 11.5 9.3 9.8 8.6 7.0 5 4.6 4.5 2.5 0 0 0 Povidone iodine n=191 n=186 n=54 n=44 n=34 n=41 n=29 n=26 n=57 n=44 n=40 n=42 n=35 n=26 ChloraPrep Colorectal Biliary Small Gastro- Thoracic Gynaecologic Urologic intestinal esophogeal The number needed to treat with ChloraPrep instead of povidone iodine in order to prevent one case of SSI was approximately 17 Conclusions ChloraPrep is superior to povidone iodine in preventing wound infections after clean-contaminated surgery The superior protection afforded by ChloraPrep may be attributed to the rapid, residual and persistent antimicrobial activity despite exposure to bodily fluids of the combination of 2% chlorhexidine and alcohol
  • 4. Prescribing Information Avoid contact with eyes, mucous membranes, middle ear and neural tissue. Should not be used in ChloraPrep速 (PL31760/0002) & ChloraPrep with Tint (PL31760-0001) 2% chlorhexidine gluconate children under 2 months of age. Solution is flammable. Do not use with ignition sources until dry, do w/v / 70% isopropyl alcohol v/v cutaneous solution. Indication: Disinfection of skin prior to invasive not allow to pool, and remove soaked materials before use. Over-vigorous use on fragile or sensitive medical procedures. Dosage & administration: ChloraPrep 0.67ml, 1.5ml, 3ml, 10.5ml, 26ml; skin or repeated use may lead to local skin reactions. At the first sign of local skin reaction, application ChloraPrep with Tint 3ml, 10.5ml, 26ml. Volume dependent on invasive procedure being undertaken. should be stopped. Per applicator costs (ex VAT) ChloraPrep 0.67ml (SEPP) - 30p; 1.5ml (FREPP) Applicator squeezed to break ampoule and release antiseptic solution onto sponge. Solution applied - 55p; 3ml - 85p; 10.5ml - 贈2.92; 26ml - 贈6.50. ChloraPrep with Tint 3ml - 89p; 10.5ml - 贈3.07; 26ml by gently pressing sponge against skin and moving back and forth for 30 seconds. The area covered - 贈6.83. Legal category: GSL. Marketing Authorisation Holder: CareFusion UK 244 Ltd, 43 should be allowed to air dry. Side effects, precautions & contra-indications: Very rarely allergic London Road, Reigate, Surrey RH2 9PW, UK. Date of preparation: July 2010. 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. CHL101a Date of preparation: August 2010