Nimoz, 1996

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0.25% chlorhexidene (with 0.025%benzalkonium chloride and 4% benzyl alcohol) versus 10% povidone iodine for skin cleansing prior to central venous or arterial catheter insertion and site care thereafter.

0.25% chlorhexidene (with 0.025%benzalkonium chloride and 4% benzyl alcohol) is better than 10% povidone iodine to prevent central venous or arterial catheter colonisation and infection.

Level of Evidence: 1⁺ (RCT with a low risk of bias)

Citation/s: Mimoz O, et al. Prospective , randomized trial of two antiseptic solutions for prevention of central venous or arterial catheter colonization and infection in intensive care unit patients. Critical Care Medicine, 1996;24 1818-23
Lead author's name and fax: Mimoz, O

Three-part Clinical Question: Is chlorhexidene (0.25% chlorhexidene gluconate/0.025% benzalkonium chloride and 4% benzyl alcohol) skin antisepsis and site care more effective at preventing catheter colonisation and catheter associated infections than povidone iodine (10%) in ITU patients ? (catheter refers to central venous catheter or arterial catheter)

Search Terms: See summary page.

The Study: Single-blinded randomised controlled trial with intention-to-treat.

The Study Patients: Consecutive patients age 18 years or older scheduled to receive a non-tunnelled central venous catheter and / or arterial catheter in a 12 bedded surgical intensive care unit.

Definitions:

Catheter Colonisation: greater or equal to 10³ cfus per ml by quantitative culture.

Catheter-Related Sepsis: qualitataive culture of organism (irrespective of quantity), sepsis (defined by temperature of greater or equal to 38.5degrees) with a sustained fall of at least 1 degree of body temp within 48hrs of catheter removal and no other cause of fever

Bacteraemic Catheter Related Sepsis: was defined as the recovery of the same organism from catheter tip and blood culture. (same organism defined as same species and same antibiotic susceptibility profile)

Control group: Cutaneous disinfection of the catheter site from time of catheter insertion to time of catheter removal was 10% povidone iodine

Experimental group: Cutaneous disinfection of the catheter site from time of catheter insertion to time of catheter removal was 0.25% chlorhexidene gluconate, 0.025% benzalkonium chloride and 4% benzyl alcohol.

The Evidence:

Rate of "infections" per 1000 catheter days (significantly lower) Alines and CVCs
	Control	Intervention (chlorhexidene)	RR	P
	Per 1000 catheter days	Per 1000 catheter days
Catheter Colonisation	31	12	0.4 (95%CI 0.1-0.9)	< 0.01
Catheter Related Sepsis	16	6	0.4 (95%CI 0.1-0.9)	=0.05
Bacteraemic Catheter Related Sepsis	4	3	0.7 (95%CI 0.1-2.2)	=0.4 (not significant)

Rate of "infections" per 1000 catheter days (significantly lower) CVCs only
CVCs only	Control	Intervention (chlorhexidene)	RR	P
	Per 1000 catheter days	Per 1000 catheter days
Catheter Colonisation	31	8	0.3 (95%CI 0.1-1.0)	=0.03
Catheter Related Sepsis	19	5	0.3 (95%CI 0.1-1.0)	=0.02

Comments:

The results show that chlorhexidiene/alcohol preparation reduces the incidence of catheter colonization and (one definition at least) of catheter related bloodstream infection.

Catheters were placed by physicians wearing gowns, caps, surgical masks and sterile gloves.

There was a written protocol for catheter care in the unit to standardize management.

Catheters were removed when catheters were no longer required, if there was suspision of catheter related infection (fever > 38.5 or hypothermia< 36.3 without any apparent cause and or signs of infection at the insertion site. And routinely at 7 days for a lines, 15 days for central venous catheters.

Larger effects on Gram Positive Bacteria than Gram Negatives.

EBM questions:

1) Do the methods allow accurate testing of the hypothesis? Yes
2) Do the statistical tests correctly test the results to allow differentiation of statistically significant results? Yes
3) Are conclusions valid in light of the results? Yes
4) Did results get omitted, and why? No
5) Did they suggest areas of further research? Yes. The potential benefits of this new antiseptic solution need to be evaluated in a larger study and the effects of the antiseptic on Gram negative infections needs further evaluation.
6) Did they make any recommendations based on the results and were they appropriate? They recommended the use of the alcohol based solution of 0.25% chlorhexidene gluconate and 0.025% benzalkonium chloride rather than10% povidone iodine fro cutaneous disinfection before insertion of a short -term intravascular device and for post insertion care.
7) Is the study relevant to my clinical practice? Yes
8) What level of evidence does this study represent? 1⁺
9) What grade of recommendation can I make on this result alone? B

10) What grade of recommendation can I make when this study is considered along with other available evidence? B
11) Should I change my practice because of these results? Probably
12) Should I audit my current practice because of these results? Probably

Appraised by: Andrew Longmate, Stirling Royal Infirmary, June 2005
Email: Andrew.Longmate@fvah.scot.nhs.uk

Kill or Update By: June 2010

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