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 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
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® (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 - £2.92; 26ml - £6.50. ChloraPrep with Tint – 3ml - 89p; 10.5ml - £3.07; 26ml
by 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, 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