Infection Risk with Nitrofurazone-Impregnated Urinary Catheters in Trauma Patients

A Randomized Trial

4 September 2007 | Volume 147 Issue 5 | Pages 285-293

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.

Editors' Notes Context Indwelling urinary catheters increase risk for bacteriuria and clinically significant urinary tract infection. Contribution In this randomized trial, trauma patients who received a catheter impregnated with nitrofurazone were less likely to have bacteriuria and funguria than were those who received a standard silicone catheter. They were also less likely to need a change in antibiotic or addition of new antibiotics. Caution Data on outcomes were missing for many patients. Implication By reducing the incidence of bacteriuria and funguria, nitrofurazone-impregnated urinary catheters appear to reduce the need to change or prescribe new antimicrobial therapy in patients who require indwelling catheters. —The Editors

 

Author and Article 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{at}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.

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