Anti-infective external coating of central venous catheters: a randomized, noninferiority trial comparing 5-fluorouracil with chlorhexidine/silver sulfadiazine in preventing catheter colonization
Department of Anesthesiology; Department of Surgery
Medical Subject Headings
Anti-Infective Agents, Local; Antibiotic Prophylaxis; Antimetabolites; Catheter-Related Infections; Catheterization, Central Venous; Catheters, Indwelling; Chlorhexidine; Colony Count, Microbial; Female; Fluorouracil; Humans; Intensive Care; Male; Middle Aged; Prospective Studies; Silver Sulfadiazine; Single-Blind Method; Treatment Outcome
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.