Infection risk with nitrofurazone-impregnated urinary catheters in trauma patients: a randomized trial.
BACKGROUND
Urinary tract infection is one of the most common nosocomial infections in hospitalized patients. It is predominantly associated with indwelling urinary catheters.


OBJECTIVE
To determine whether nitrofurazone-impregnated urinary catheters reduce the incidence of catheter-associated bacteriuria and funguria (CABF).


METHODS
Randomized, double-blind, controlled trial.


METHODS
Copenhagen Trauma Center, Copenhagen, Denmark.


METHODS
212 consecutive adult trauma patients admitted between July 2003 and August 2005. Eligible patients needed a urinary catheter on arrival and were excluded if they were HIV positive, were pregnant, had a primary burn injury, or were receiving steroid treatment or if informed consent was unattainable.


METHODS
Nitrofurazone-impregnated or standard silicone catheter throughout the duration of catheterization.


METHODS
Catheter-associated bacteriuria and funguria, defined as at least 10(3) colony-forming units/mL, was assessed daily until removal of the catheter, with a prespecified minimum of 24-hour follow-up for the primary analysis. The microbiologist was blinded to study group assignment.


RESULTS
1190 urine cultures were obtained over 1001 catheter-days. Catheter-associated bacteriuria and funguria occurred less frequently in the nitrofurazone catheter group than in the silicone catheter group (7 of 77 [9.1%] vs. 19 of 77 [24.7%]; incidence per 1000 catheter-days, 13.8 vs. 38.6; adjusted risk, 0.31 [95% CI, 0.14 to 0.70]; P = 0.005). Onset of CABF was delayed in the nitrofurazone group (P = 0.01), and nitrofurazone catheters led to fewer instances of new or changed antimicrobial therapy (adjusted risk, 0.27 [CI, 0.10 to 0.69]; P = 0.006).


CONCLUSIONS
The clinical significance of asymptomatic bacteriuria and funguria is unclear. Data were missing in 27% of patients, and the magnitude of effect of the nitrofurazone catheters varied by assumptions about outcomes in patients who did not complete 24-hour follow-up.


CONCLUSIONS
Nitrofurazone-impregnated urinary catheters reduced the incidence of CABF in adult trauma patients, reducing the need to change or prescribe new antimicrobial therapy. ClinicalTrials.gov registration number: NCT00192985.
Stensballe
Jakob
J
Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. jakob.stensballe@rh.regionh.dk
Tvede
Michael
M
Looms
Dagnia
D
Lippert
Freddy Knudsen
FK
Dahl
Benny
B
Tønnesen
Else
E
Rasmussen
Lars Simon
LS
D000328:Adult; D000892:Anti-Infective Agents, Urinary / Q000008:administration & dosage*; D001424:Bacterial Infections / Q000517:prevention & control; D002408:Catheters, Indwelling / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D009181:Mycoses / Q000517:prevention & control; D009583:Nitrofurazone / Q000008:administration & dosage*; D014546:Urinary Catheterization / Q000009:adverse effects*; D014552:Urinary Tract Infections / Q000517:prevention & control*; D014947:Wounds and Injuries / Q000628:therapy*