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Infection Risk with Nitrofurazone-Impregnated Urinary Catheters in Trauma Patients: A Randomized Trial

Jakob Stensballe, PhD; Michael Tvede, MD; Dagnia Looms, PhD; Freddy Knudsen Lippert, MD; Benny Dahl, DMSc; Else Tønnesen, DMSc; and Lars Simon Rasmussen, PhD
[+] Article, Author, and Disclosure Information

From Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Coloplast A/S, Humlebaek, Denmark; and Aarhus University Hospital, Aarhus, Denmark.

Acknowledgments: The authors thank the laboratory personnel at the Department of Clinical Microbiology, Rigshospitalet, and the trauma teams, for making this study possible. They also thank Søren Nymand Lophaven, PhD, for expert statistical assistance. They are indebted to the participants and their relatives.

Grant Support: By an unrestricted research grant to Jakob Stensballe from Coloplast A/S and grants from the Foundation in Commemoration of Holger and Ruth Hesse (Copenhagen); the Danish Hospital Foundation for medical research, region of Copenhagen, The Faroe Islands and Greenland; and H:S Research Committee, Copenhagen.

Potential Financial Conflicts of Interest: Employment: D. Looms (Coloplast A/S). Grants received: J. Stensballe (Coloplast A/S).

Requests for Single Reprints: Jakob Stensballe, PhD, Department of Anesthesia, Centre of Head and Orthopedics, Rigshospitalet, Copenhagen University Hospital, 9 Blegdamsvej, DK-2100 Copenhagen, Denmark; e-mail, jakob.stensballe@rh.regionh.dk.

Current Author Addresses: Dr. Stensballe: Department of Anesthesia, Centre of Head and Orthopedics, Rigshospitalet, Copenhagen University Hospital, 9 Blegdamsvej, DK-2100 Copenhagen, Denmark.

Dr. Tvede: Department of Clinical Microbiology, Rigshospitalet, Copenhagen University Hospital, 9 Blegdamsvej, DK-2100 Copenhagen, Denmark.

Dr. Looms: Coloplast A/S, 1 Holtedam, DK-3050 Humlebaek, Denmark.

Drs. Lippert and Rasmussen: Department of Anesthesia, Centre of Head and Orthopedics, Rigshospitalet, Copenhagen University Hospital, 9 Blegdamsvej, DK-2100 Copenhagen, Denmark.

Dr. Dahl: Department of Orthopedic Surgery, Rigshospitalet, Copenhagen University Hospital, 9 Blegdamsvej, DK-2100 Copenhagen, Denmark.

Dr. Tønnesen: Department of Anesthesiology and Intensive Care, Aarhus University Hospital, 44 Nørrebrogade, DK-8000 Aarhus, Denmark.

Author Contributions: Conception and design: J. Stensballe, M. Tvede, F.K. Lippert, B. Dahl, E. Tønnesen, L.S. Rasmussen.

Analysis and interpretation of the data: J. Stensballe, M. Tvede, D. Looms, F.K. Lippert, B. Dahl, E. Tønnesen, L.S. Rasmussen.

Drafting of the article: J. Stensballe, M. Tvede, D. Looms.

Critical revision of the article for important intellectual content: J. Stensballe, M. Tvede, D. Looms, F.K. Lippert, B. Dahl, E. Tønnesen, L.S. Rasmussen.

Final approval of the article: J. Stensballe, M. Tvede, D. Looms, F.K. Lippert, B. Dahl, E. Tønnesen, L.S. Rasmussen.

Provision of study materials or patients: J. Stensballe.

Statistical expertise: J. Stensballe.

Obtaining of funding: J. Stensballe, F.K. Lippert.

Administrative, technical, or logistic support: J. Stensballe, B. Dahl, L.S. Rasmussen.

Collection and assembly of data: J. Stensballe, M. Tvede, F.K. Lippert.

Ann Intern Med. 2007;147(5):285-293. doi:10.7326/0003-4819-147-5-200709040-00002
Text Size: A A A

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).

Design: Randomized, double-blind, controlled trial.

Setting: Copenhagen Trauma Center, Copenhagen, Denmark.

Patients: 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.

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

Measurements: Catheter-associated bacteriuria and funguria, defined as at least 103 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).

Limitations: 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.


Grahic Jump Location
Figure 1.
Study flow diagram.

CFU = colony-forming unit; ICU = intensive care unit.

Grahic Jump Location
Grahic Jump Location
Figure 2.
Onset of catheter-associated bacteriuria and funguria (CABF) in trauma patients, by type of urinary catheter.P

 = 0.01, log-rank test.

Grahic Jump Location




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Submit a Comment/Letter
nitrofurantoin systemic effects
Posted on September 10, 2007
William A Stinnette
Kaiser Permanente
Conflict of Interest: None Declared

Any evidence for systemic absorption and associated adverse effects related to nitrofurantoin, such as anemia, liver abnormalities and respiratory difficulties, including lung injury?

Conflict of Interest:

None declared

Re: nitrofurantoin systemic effects
Posted on September 13, 2007
Jakob Stensballe
Copenhagen University Hospital, Rigshospitalet. Dep of Anesthesia, Centre of Head and Orthopedics.
Conflict of Interest: None Declared

Dr. Stinnette, thank you for the interest. We found no evident adverse side effects such as anemia, liver or respiratory failure related to the nitrofurazone impregnation of the silicone catheter. This is in accordance with Marion-Landais and colleges' findings that nitrofurazone is not absorbed to the surrounding tissue or systemically (1). Furthermore, the observed adverse events in the study were found non-related to the nitrofurazone impregnation, more likely related to the procedure of catheterization.

1. Marion-Landais G, Heotis JP, Mertz JL, Diaz JR, Van Hart DC, Newsom JH, et al. Non-absorption of nitrofurazone from the urethra in men. Curr Ther Res Clin Exp. 1976.

Conflict of Interest:

Unrestricted research grant received from Coloplast A/S

Nitrofurazone-impregnated Foley catheter
Posted on September 30, 2007
James R. Johnson
Universtiy of Minnesota; Minneapolis VA Medical Center
Conflict of Interest: None Declared

To the Editor:

In their randomized clinical trial of an antimicrobial-impregnated Foley catheter, Stensballe et al. found a significantly lower frequency of new or changed antimicrobial therapy among recipients of the test catheter, as opposed to the control catheter [1]. The investigators are to be commended for examining this potentially clinically important outcome, since previous such trials have focused only on urine culture results, which are of doubtful clinical significance [2]. However, the applicability of this finding to usual hospital practice is uncertain. Notably, Stensballe et al. fed back their study's daily urine culture results to the patients' physicians, who treated asymptomatic bacteriuria/funguria whenever it was detected, as physicians tend to do [3]. This doubtless generated considerably more antimicrobial therapy than would have occurred had urine cultures been performed only twice weekly (the trauma unit's usual schedule), or for suspected infection (as is done in many acute care settings). Thus, whether an antimicrobial Foley catheter can truly improve clinical practice patterns or patient outcomes during routine use remains to be demonstrated.

1. Stensballe J, Tvede M, Looms, D, Knudsen F, Dahl B, Tonnesen E, Rasmussen LS. Infection risk with nitrofurazone-impregnated urinary catheters in trauma patients. Ann Intern Med. 2007;147:285-93.

2. Johnson JR, Kuskowski MA, Wilt TJ. Systematic review: antimicrobial urinary catheters to prevent catheter-associated urinary tract infection in hospitalized patients. Ann Intern Med. 2006;144:116-26.

3. Tambyah PA, Make DG. Catheter-associated urinary tract infection is rarely symptomatic: a prospective study of 1,497 catheterized patients. Arch Intern Med. 2000;160:678-82.

Conflict of Interest:

I have received research grants and consultancies from Rochester Medical Corp. (manufacturer of the nitrofurazone-impregnated catheter)

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