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Anti-infective external coating of central venous catheters: a randomized, noninferiority trial comparing 5-fluorouracil with chlorhexidine/silver sulfadiazine in preventing catheter colonization

Walz, J. Matthias
Avelar, Rui L.
Longtine, Karen J.
Carter, Kent L.
Mermel, Leonard A.
Heard, Stephen O.
5-FU Catheter Study Group
Faris, Khaldoun
Hall, Wiley R.
Orquiola, Alan
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Abstract

OBJECTIVE: The antimetabolite drug, 5-fluorouracil, inhibits microbial growth. Coating of central venous catheters with 5-fluorouracil may reduce the risk of catheter infection. Our objective was to compare the safety and efficacy of central venous catheters externally coated with 5-fluorouracil with those coated with chlorhexidine and silver sulfadiazine.

DESIGN: Prospective, single-blind, randomized, active-controlled, multicentered, noninferiority trial.

SETTING: Twenty-five US medical center intensive care units.

PATIENTS: A total of 960 adult patients requiring central venous catheterization for up to 28 days.

INTERVENTIONS: Patients were randomized to receive a central venous catheter externally coated with either 5-fluorouracil (n = 480) or chlorhexidine and silver sulfadiazine (n = 480).

MEASUREMENTS AND MAIN RESULTS: The primary antimicrobial outcome was a dichotomous measure (/= 15 colony-forming units) for catheter colonization determined by the roll plate method. Secondary antimicrobial outcomes included local site infection and catheter-related bloodstream infection. Central venous catheters coated with 5-fluorouracil were noninferior to chlorhexidine and silver sulfadiazine coated central venous catheters with respect to the incidence of catheter colonization (2.9% vs. 5.3%, respectively). Local site infection occurred in 1.4% of the 5-fluorouracil group and 0.9% of the chlorhexidine and silver sulfadiazine group. No episode of catheter-related bloodstream infection occurred in the 5-fluorouracil group, whereas two episodes were noted in the chlorhexidine and silver sulfadiazine group. Only Gram-positive organisms were cultured from 5-fluorouracil catheters, whereas Gram-positive bacteria, Gram-negative bacteria, and Candida were cultured from the chlorhexidine and silver sulfadiazine central venous catheters. Adverse events were comparable between the two central venous catheter coatings.

CONCLUSIONS: Our results suggest that central venous catheters externally coated with 5-fluorouracil are a safe and effective alternative to catheters externally coated with chlorhexidine and silver sulfadiazine when used in critically ill patients.

Source

Crit Care Med. 2010 Nov;38(11):2095-102. Link to article on publisher's site

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DOI
10.1097/CCM.0b013e3181f265ba
PubMed ID
20711070
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Notes

Khaldoun Faris, Wiley Hall, Alan Orquiola, Melissa O'Neill, and Jaclyn Longtine are coinvestigators from UMass Medical School in the 5-FU Study Group.

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