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2% Chlorhexidene versus 70% alcohol and 10% povidone iodine for cutaneous  preparation and site care of central venous and arterial catheter insertion sites.

Citation/s: Maki DG, et al. Prospective Randomised Trial of Povidone-Iodine, Alcohol, and Chlorhexidine for Prevention of Infection Associated with Central Venous and Arterial Catheters. Lancet, 1991: 338;  339-43

Lead author's name and fax: Maki, DG

Three-part Clinical Question: Does cutaneous antisepsis (and site care thereafter) with 2% chlorhexidene prior to vascular catheter insertion reduce the rate of infection associated with arterial and central venous catheterisation in ITU patients? (compared with 70% alcohol or povidone iodine)
 

Search Terms: See summary page

The Study: Single-blinded randomised controlled trial with intention-to-treat. The users of solutions and research nurses were not blinded but the research microbiologist who processed all cultures was blinded.
 

The Study Patients: All patients over 18 years of age scheduled to receive a central venous or arterial catheter in a 20 bedded surgical intensive care unit.

Definitions:

“Local Catheter Related Infection”= positive semi quantitative culture of the catheter (15cfus) regarded as synonymous with colonization of the catheter.

“Catheter Related bacteraemia /septicaemia” = positive semiquantitive culture and blood cultures positive for same microbial species with negative infusate and no other apparent  source of septicaemia.

Control group (N = 454; 454 analysed): The site of insertion of the catheter was cleansed by vigorous scrubbing for 30 seconds with either 70% isopropyl alcohol or 10% povidone-iodine solution. The catheter was dressed with sterile gauze and tape and inspected and recleansed with the same solution every 48 hours.
 

Experimental group (N = 214; 214 analysed): 2% aqueous chlorhexidene gluconate was applied to the site of insertion with vigorous scrubbing for 30 seconds before being allowed to dry. The catheters were dressed with sterile gauze and tape and inspected and recleansed with the same solution every 48 hrs.

The Evidence:

Central Venous Catheters and Arterial Catheters:

Central Venous Catheters Only:

Comments:

The results show that chlorhexidine skin preparation reduces bacterial colonization of central venous and arterial catheters.

The trial’s terminology is somewhat confusing. The definition for “Local Catheter Related Infection” is more commonly interpreted as colonization. (The investigators acknowledge this).

The catheters were placed by house officers. Experience of the “operator” may affect infectious complications.

The operator wore sterile gloves. Strict aseptic technique may affect infectious complications.

20-24% of central catheters (and 28-32% of arterial catheters) were inserted in "old" sites over a guidewire. This practice might be associated with a higher risk of catheter related sepsis.

The majority of catheters in this study were arterial lines. (alines = 492 CVCs =176)

The insertion site for catheters was not controlled and was mainly subclavian.

Decisions to remove catheters were made independently by the patient's physicians.

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? This is unclear
5) Did they suggest areas of further research? Yes, Further prospective randomised controlled clinical trials in which rates of infection, rather than levels of colonisation are used as the criterion for antiseptic efficacy.
6) Did they make any recommendations based on the results and were they appropriate?  Yes. They comment that the findings "suggest" that chlorhexidene should be considered as a first line antiseptic for prevention of infection with percutaneously inserted intravascular devices. This seems appropriate.
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: Dr Andrew Longmate. Stirling Royal Infirmary ; June 2005
Email: Andrew.Longmate@fvah.scot.nhs.uk

Kill or Update By: May 2010

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