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Comparison of Soap and Antibiotic Solutions for Irrigation of Lower-Limb Open Fracture Wounds

A Prospective, Randomized Study

¹ Department of Orthopaedics, Indiana University, 541 Clinical Drive, Suite 600, Indianapolis, IN 46202-5111. E-mail address: janglen{at}iupui.edu

Investigation performed at the Department of Orthopaedics, University of Missouri, Columbia, Missouri

A commentary is available with the electronic versions of this article, on our web site (www.jbjs.org) and on our quarterly CD-ROM (call our subscription department, at 781-449-9780, to order the CD-ROM).

NOTE: The author thanks Dr. Eric Malicky and Dr. Jim Edwards for their help with the execution of this study; Paula Harrison, Tabitha Stith, Linda Landry, Kim Suppes, and Katy Goss for their data collection; Diane Anglen and Elena Penn for their work in organizing and executing the intraoperative components of the study; and Dr. Barry Gainor, Dr. Gordan Christensen, and Dr. W. Andrew Simpson for their collaboration in the laboratory investigations of surfactant irrigations.

Methods: Adult patients with an open fracture of the lower extremity were prospectively randomized to receive irrigation with either a bacitracin solution or a nonsterile castile soap solution. The patients were followed clinically to assess for the development of infection, healing of the soft-tissue wound, and union of the fracture.

Results: Between 1995 and 2002, 400 patients with a total of 458 open fractures of the lower extremity were entered into the study. One hundred and ninety-two patients were assigned to the bacitracin group (B), and 208 were assigned to the castile soap group (C). Outcomes were available for 171 patients with a total of 199 fractures in group B and 180 patients with a total of 199 fractures in group C. The mean duration of follow-up was 500 days. There was no difference between groups B and C in terms of gender, the Gustilo-Anderson grade of the open fracture, the time between the injury and the irrigation, smoking, or alcohol use. There were significant differences in the mean age (thirty-eight compared with forty-two years, p = 0.01), duration of follow-up (560 compared with 444 days, p = 0.01), prevalence of hypotension (23% compared with 14%, p = 0.04), and duration of treatment with intravenous antibiotics (eleven compared with nine days, p = 0.02). An infection developed at thirty-five (18%) of the 199 fracture sites in group B and at twenty-six (13%) of the 199 fracture sites in group C. This difference was not significant (p = 0.2). Bone-healing was delayed for forty-nine (25%) of the 199 group-B fractures and forty-six (23%) of the 199 group-C fractures (p = 0.72). Wound-healing problems occurred in association with nineteen group-B fractures (9.5%) and eight group-C fractures (4%). This difference was significant (p = 0.03).

Conclusions: Irrigation of open fracture wounds with antibiotic solution offers no advantages over the use of a nonsterile soap solution, and it may increase the risk of wound-healing problems.

Level of Evidence: Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.

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Comparison of Soap and Antibiotic Solutions for Irrigation of Lower-Limb Open Fracture Wounds

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JBJS 2006 88: 452. [Extract] [Full Text]  

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