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0.5% chlorhexidine vs Povidone Iodine, A RCT

Citation/s: Humar A, et al. Prospective Randomised Trial of 10% Povidone-Iodine versus 0.5% Tincture of Chlorhexidine as Cutaneous Antisepsis for Prevention of Central Venous Catheter Infection. Clinical Infectious Disease 2000; 31: 1001-7
Lead author's name and fax: Humar, A

Three-part Clinical Question: Does cutaneous antisepsis (and site care thereafter) with 0.5% chlorhexidene prior to vascular catheter insertion reduce the rate of infection associated with arterial and central venous catheterisation in ITU patients ? (when compared to cutaneous antisepsis with alcohol or povidone iodine)
 

Search Terms: See summary page.

The Study: Single-blinded randomised controlled trial with intention-to-treat. Lab staff were blinded but ward staff were not.
 

The Study Patients: Patients 18 years of age (in one of 4 intensive care units) who had CVCs inserted when the treating clinician felt the inserted catheter would be present for a minimum of 72 hours.

Definitions:

Catheter related bacteraemia: a single positive blood culture, with no other source of bacteremia, in the presence of a culture of a catheter segment from which the same organism was isolated as confirmed by molecular subtyping. Isolates were characterized by susceptibility testing  and with molecular subtyping with pulsed-field gel electrophoresis (PFGE).                                                                                                                                       Significant Catheter Tip Colonisation: (local catheter infection) was defined as growth of greater or equal to 15cfus from a semiquantitative culture of the catheter tip by the roll plate technique.

Control group: (N = 117; 117 analysed): Use of 10% povidone-iodine as the agent for initial and cutaneous antisepsis for catheter care. Sterile gauze dressings were changed every 72 hours or sooner if soiled or wet.
 

Experimental group: (N = 125; 125 analysed): Use of 0.5% tincture of chlorhexidene as the agent for initial and subsequent cutaneous antisepsis for catheter care. Sterile gauze dressings were changed every 72 hours or sooner if soiled or wet.

The Evidence:

Comments:

The results show no difference in catheter related blood stream infection rates between chlorhexidine and povidone iodine when used for cutaneous asepsis. All catheters were inserted by surgical or medical staff who used maximal barrier precautions with sterile gloves, gown mask and largedrapes.

The study had inadequate power.  Because of lower than expected patient recruitment the study did not have sufficient power to detect a difference in catheter related bacteraemia rates. The study did have the power to detect differences in rates of local catheter infection (colonisation).

Peripheral alines, peripheral CVCs and catheters over guidewires not included.

Decisions to remove catheters were made independently by treating physicians.

Chlorhexidene group was catheterized longer.

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? No Lower than anticipated enrollment meant that the study lacked sufficient power to demonstrate a difference between the two treatment arms. (because 35% of patients enrolled had CVC for < 72hrs). Didn't have power to detect catheter related bacteraemia difference. But did have power to detect differences between rates of local catheter related infection. (ie colonization of catheter tip)
3) Are conclusions valid in light of the results? Yes
4) Did results get omitted, and why? Yes 26% of catheter tips were not recovered
5) Did they suggest areas of further research? No..
6) Did they make any recommendations based on the results and were they appropriate? No                                                            

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? none

10) What grade of recommendation can I make when this study is considered along with other available evidence? none
11) Should I change my practice because of these results? unclear
12) Should I audit my current practice because of these results? unclear

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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