Background: Irrigation of open fracture wounds is a commonly
performed procedure, and irrigation additives have been used in an attempt to
reduce the risk of infection. In vitro and animal studies have suggested that
irrigation with detergent solution is more effective than irrigation with a
solution containing antibiotic additives. This study was performed to compare
the efficacy of those two solutions in the treatment of open fractures in
humans.
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.