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 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 optimal

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

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

Aim

Methods

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)

p=0.49

Incidence of incisional infections (% patients)

Superficial incisional infection

Deep incisional infection

Povidone iodine n=440

ChloraPrep n=409

p=0.05

10

8

6

4

2

0

3.0

1.0

8.6

4.2

p=0.008

Povidone iodinen=440

ChloraPrepn=409

Incidence of SSIs (% patients)

20

15

10

5

0

9.5

16.1

p=0.004

ChloraPrep reduced SSIs after clean-contaminated surgery by 41% as compared with povidone iodine scrub and paint

Results

Povidone iodine

ChloraPrep

Incidence of SSIs by surgery type (%)

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

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

Colorectal Biliary Small intestinal

Gastro- esophogeal

Thoracic Gynaecologic Urologic

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

35

30

25

20

15

10

5

0

22.0

15.1

9.3

4.6

29.4

9.8

20.7

11.5

7.0

4.5

2.5 0

8.6

0

Conclusions

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

Prescribing InformationChloraPrep® (PL31760/0002) & ChloraPrep with Tint (PL31760-0001) 2% chlorhexidine gluconate w/v / 70% isopropyl alcohol v/v cutaneous solution. Indication: Disinfection of skin prior to invasive medical procedures. Dosage & administration: ChloraPrep – 0.67ml, 1.5ml, 3ml, 10.5ml, 26ml; ChloraPrep with Tint – 3ml, 10.5ml, 26ml. Volume dependent on invasive procedure being undertaken. Applicator squeezed to break ampoule and release antiseptic solution onto sponge. Solution applied by gently pressing sponge against skin and moving back and forth for 30 seconds. The area covered should be allowed to air dry. Side effects, precautions & contra-indications: Very rarely allergic 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.

Avoid contact with eyes, mucous membranes, middle ear and neural tissue. Should not be used in children under 2 months of age. Solution is flammable. Do not use with ignition sources until dry, do not allow to pool, and remove soaked materials before use. Over-vigorous use on fragile or sensitive skin or repeated use may lead to local skin reactions. At the first sign of local skin reaction, application should be stopped. Per applicator costs (ex VAT) ChloraPrep – 0.67ml (SEPP) - 30p; 1.5ml (FREPP) - 55p; 3ml - 85p; 10.5ml - £2.92; 26ml - £6.50. ChloraPrep with Tint – 3ml - 89p; 10.5ml - £3.07; 26ml - £6.83. Legal category: GSL. Marketing Authorisation Holder: CareFusion UK 244 Ltd, 43 London Road, Reigate, Surrey RH2 9PW, UK. Date of preparation: July 2010.

CHL101a Date of preparation: August 2010