A large multicenter clinical trial, conducted at the University of Maryland School of Medicine, shows that the use of an iodinated antiseptic significantly reduces the risk of surgical wound infections in patients with extremity fractures. The new data, published in the New England Journal of Medicine (NEJM), could prevent thousands of surgical wound infections each year.
Bone Fracture
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Background and Significance of the Study
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It is estimated that about three percent of patients who suffer an arm, leg, or pelvis fracture and require surgery develop a surgical site infection (SSI). The source of the bacteria can be the patient’s skin, the wound environment, or the hospital. Although some guidelines favor the use of chlorhexidine gluconate over iodine-based products, there is no consensus on which agent is most effective.
Iodine-Based Antiseptics vs. Chlorhexidine Gluconate
However, iodine-based antiseptics appear to prevent a greater number of surgical infections in fracture patients than chlorhexidine gluconate, this large multicenter clinical trial concludes that an iodine-based antiseptic reduces the number of postoperative infections in patients treated for limb fractures by about a quarter, compared with another commonly used skin antiseptic.
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Detailed Analysis of the Clinical Trial
The study, which included 8,485 patients from the United States and Canada, compared the two most commonly used alcohol-based solutions, one with Povacrylex iodine and the other with chlorhexidine gluconate, and assessed their effectiveness in patients with closed or simple fractures – leaving the skin intact. Although the study involved more than 6,700 patients undergoing surgery to treat a closed lower limb fracture or pelvic fracture and 1,700 patients undergoing surgery to treat an open fracture, no differences in effectiveness between the two types of antiseptic solutions were noted in the case of complex fractures with open wounds, although the researchers indicated that the use of the iodine preparation was not harmful to patients with an open fracture.
Key Results and Implications
The analysis showed that of the 3,205 patients with closed fractures who received povacrylex 0.7 percent iodine in 74 percent isopropyl alcohol, 2.4 percent developed SSI compared with 3.3 percent of 3,272 patients who received a 2 percent chlorhexidine gluconate solution in 70 percent isopropyl alcohol. In patients with open fractures, the number of patients who developed infections was similar between the two antiseptics, with an estimated SSI rate between 6.5 and 7.3%.
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Final Thoughts
The findings from this study, highlighting povacrylex iodine’s role in reducing SSIs in fracture surgeries, are pivotal. Dr. Gerard Slobogean and Dr. Todd Jaeblon put it aptly: “This well-designed study provides orthopedic trauma surgeons with clarity on what antiseptic skin preparations to use in preparation for fracture surgery.” The potential to prevent thousands of SSIs each year is not just a clinical advancement but a step towards more efficient, cost-effective healthcare. This research sets a new benchmark in surgical care, guiding future practices and studies in the field.
References
The PREP-IT Investigators. (2024, February 1). Skin Antisepsis before Surgical Fixation of Extremity Fractures. New England Journal of Medicine, 390, 409-420. https://doi.org/10.1056/NEJMoa2307679
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