Chlorhexidine-alcoholversus povidone iodinefor surgical-site antisepsisDarouiche RO, Wall MJ, Itani KMF, Otterson MF, Webb...
Results                          ChloraPrep reduced SSIs after clean-contaminated surgery by 41% as compared with         ...
Lower rates of SSI were observed in the ChloraPrep group than in the povidone iodine                           group for e...
Prescribing Information                                                                                  Avoid contact wit...
Upcoming SlideShare
Loading in …5
×

Darouiche Clinical Summary | ChloraPrep UK Infection Prevention & Control

881 views

Published on

Darouiche Clinical Summary | ChloraPrep UK Infection Prevention & Control

Published in: Health & Medicine, Business
0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total views
881
On SlideShare
0
From Embeds
0
Number of Embeds
4
Actions
Shares
0
Downloads
7
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

Darouiche Clinical Summary | ChloraPrep UK Infection Prevention & Control

  1. 1. Chlorhexidine-alcoholversus povidone iodinefor surgical-site antisepsisDarouiche RO, Wall MJ, Itani KMF, Otterson MF, Webb AL, Carrick MM, Miller HJ,Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DHNew England Journal of Medicine 2010; 362: 18-26Background The patient’s 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 optimalAim To compare the efficacy of ChloraPrep (2% chlorhexidine gluconate / 70% isopropyl alcohol) applicators versus povidone iodine scrub and paint in preventing SSIsMethods 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. 2. Results ChloraPrep reduced SSIs after clean-contaminated surgery by 41% as compared with povidone iodine scrub and paint 20Incidence 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) 10Incidence of p=0.008incisional 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. 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 35Incidence of SSIsby 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 17Conclusions 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. 4. Prescribing Information Avoid contact with eyes, mucous membranes, middle ear and neural tissue. Should not be used inChloraPrep® (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, dow/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 sensitivemedical 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, applicationChloraPrep 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 - £2.92; 26ml - £6.50. ChloraPrep with Tint – 3ml - 89p; 10.5ml - £3.07; 26mlby gently pressing sponge against skin and moving back and forth for 30 seconds. The area covered - £6.83. Legal category: GSL. Marketing Authorisation Holder: CareFusion UK 244 Ltd, 43should 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-indicatedfor patients with known hypersensitivity to these constituents. For external use only on intact skin. CHL101a Date of preparation: August 2010

×