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Applying iodine povacrylex in alcohol instead of chlorhexidine gluconate before surgery is associated with fewer surgical site infections in closed, but not open, extremity fractures, new research suggested.

"The results of this trial are poised to have many hospitals considering a policy change to use iodine povacrylex in alcohol for fracture surgeries, as it reduces surgical site infections in closed fractures and is not harmful in patients with open fractures," study author Sheila Sprague, MD, an associate professor of surgery at McMaster University in Hamilton, Ontario, Canada, told Medscape Medical News.

The cluster-randomized, crossover trial at 25 hospitals in Canada and the United States showed that surgical site infections occurred in 2.4% of patients with closed fractures in the iodine group vs 3.3% of those in the chlorhexidine group. Surgical site infections were similar for both groups in the open fracture population: 6.5% in the iodine group and 7.3% in the chlorhexidine group.

"With over a million fracture surgeries performed annually in North America, the use of iodine povacrylex in alcohol as preoperative skin antisepsis has the potential to prevent surgical site infection in thousands of patients with closed fractures each year," said Sprague. "This trial may lead to major changes in clinical practice."

The study was published online on February 1 in the New England Journal of Medicine.

Iodine or Chlorhexidine?

Studies evaluating surgical site infection have had conflicting results regarding skin antisepsis before surgery to repair an extremity fracture, the researchers wrote. Their multicenter trial compared the two most common approaches in Canada and the United States for closed and open fractures.

The researchers randomly assigned participating hospitals to use a solution of 0.7% iodine povacrylex in 74% isopropyl alcohol (3M Duraprep Surgical Prepping Solution) or 2% chlorhexidine gluconate in 70% isopropyl alcohol (BD ChloraPrep; 3M SoluPrep S Sterile Antiseptic Solution) for participating patients with fractures.

The closed fracture population consisted of adults undergoing surgical fixation of a closed lower limb or pelvic fracture, whereas the open fracture population consisted of adults undergoing surgical fixation of an open upper or lower limb fracture. The open fracture also must have received surgical débridement within 72 hours after the injury.

The hospitals alternated interventions every 2 months. Separate populations of patients with open or closed fractures were enrolled and included in the analysis. Outcomes were assessed at 3 months, 6 months, 9 months, and 12 months after the fracture.

The primary outcome was surgical site infection, that is, superficial incisional infection within 30 days or deep incisional or organ-space infection within 90 days. The secondary outcome was unplanned reoperation for complications related to fracture healing.

The trial included 6785 patients with a closed fracture (mean age, 53 years; 51% women) and 1700 patients with an open fracture (mean age, 45 years; 64% men).

Among participants with a closed fracture, surgical site infection occurred in 77 patients (2.4%) in the iodine group and in 108 (3.3%) in the chlorhexidine group (odds ratio, 0.74), which was a significant difference.

In the open fracture population, surgical site infection occurred in 54 patients (6.5%) in the iodine group and 60 patients (7.3%) in the chlorhexidine group (odds ratio, 0.86). One-year outcomes, serious adverse events, and the frequencies of unplanned reoperation were similar between groups.

One limitation of the study was a lower-than-anticipated baseline infection risk in the open fracture group, which reduced the statistical power of the comparison. There was better adherence among patients in the chlorhexidine group, which might have affected the observed treatment effect. Varying cluster sizes might have led to a prognostic imbalance. Also, the generalizability to patients undergoing surgery for an indication other than a fracture is unknown.

Potential to Save Lives

Commenting on the study for Medscape Medical News, Mandeep S. Tamber, MD, PhD, associate head of neurosurgery at The University of British Columbia and chair of the Mortality Review Committee at BC Children's and BC Women's Hospitals, Vancouver, British Columbia, Canada, said, "The authors should be commended for designing and executing a well-run clinical trial demonstrating that a relatively minor change to perioperative infection prevention practices, using a commonly available, easily implemented, and generally inexpensive intervention, can have an important effect on infection prevention, potentially saving many lives." Tamber did not participate in the research.

"The results of this study do need to be replicated in other populations and for other types of operations. A logical next step would be to apply this type of study design to other surgical populations, such as children, and other types of surgical procedures."

In a related editorial, Selwyn O. Rogers Jr, MD, MPH, James E. Bowman Jr, professor of surgery at the University of Chicago Medicine, Chicago, Illinois, and Richard P. Wenzel, MD, emeritus professor and chair of internal medicine at Virginia Commonwealth University in Richmond, Virginia, wrote that the trial is "rigorous and well designed." Nevertheless, they pointed to the fact that the investigators could not evaluate sources of organisms outside of the skin that might also be causing surgical site infections, such as Staphylococcus aureus in the nasopharynx and gut.

"[W]e need more innovative trials testing novel approaches to further lower the infection risk," Rogers and Wenzel wrote. "Moreover, a deeper understanding of the individual patient’s microbiome may allow for tailored interventions to further decrease the incidence of infection…We await next-generation innovations to achieve zero surgical site infections."

The study was funded by a grant from the Patient-Centered Outcomes Research Institute and by the Canadian Institutes of Health Research. Sprague and Tamber disclosed no conflicts of interest. Rogers and Wenzel are editors of the New England Journal of Medicine.