Results Summary

What was the research about?

Patients who have surgery to repair a fracture, or broken bone, are at high risk for an infection. Infections can lead to unplanned surgeries, the loss of a limb, or even death. Before surgery, doctors apply an antiseptic solution to cleanse the patient’s skin to help prevent infection. But questions remain about which type of solution works best to prevent infections.

In this study, the research team compared two antiseptic solutions used before surgery for a fracture:

  • Iodine povacrylex
  • Chlorhexidine gluconate

The research team wanted to learn if one solution worked better than the other to prevent infections at the surgery site and unplanned repeat surgeries. The team looked at people who had open and closed factures. With open fractures, bones break through the skin. Closed fractures don’t break through the skin.

What were the results?

After three months, for patients with closed fractures, the use of iodine povacrylex resulted in fewer infections than the use of chlorhexidine gluconate. Of those who received iodine povacrylex, 2.4 percent had infections compared with 3.3 percent of those who received chlorhexidine gluconate. For patients with open fractures, the number of infections didn’t differ between the two solutions.

After one year, for all patients, the number of unplanned surgeries didn’t differ based on which of the two solutions patients used.

Who was in the study?

The study included 8,485 adults who had surgery to treat a fracture. All received care in one of 25 hospitals in the United States and Canada. A total of 6,785 patients had closed fractures. Of these, 79 percent were White, 15 percent were African American, 4 percent were Asian, and 1 percent were Indigenous; race was missing for 1 percent. The average age was 54, and 51 percent were women. A total of 1,700 patients had open fractures. Of these, 69 percent were White, 26 percent were African American, 2 percent were Asian, and 1 percent were Indigenous; race was missing for 1 percent. The average age was 45, and 64 percent were men.

What did the research team do?

The research team assigned hospitals by chance to use one antiseptic solution for two months. Hospitals then switched to the other solution for two more months. Hospitals repeated this process every two months during the study. The team contacted patients and reviewed health records for infections and unplanned surgeries up to one year after surgery.

Patients who had infections after surgery, clinicians, and members of surgical organizations helped design the study.

What were the limits of the study?

Hospitals differed in the number of patients in the study, which could have made it harder to find differences between the two solutions.

Future research could compare how well the antiseptic solutions work to reduce infections among patients having other types of surgeries.

How can people use the results?

Doctors can use the results when considering how to prevent infections among people having surgery for fractures.

Final Research Report

This project's final research report is expected to be available by November 2024.

Engagement Resources

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.

Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:

  • The reviewers asked for additional information about the composition and meeting frequency of the Patient Advisory Core. The researchers clarified the roles of the patients and stakeholders in the group, explaining for instance that three of the group members were patient representatives with lived experience of surgical complications and surgical site infections.
  • The reviewers noted that subgroup analyses were not described consistently in the report. The researchers added language in the introduction explaining who would be considered part of a high-risk subgroup for closed fractures and for open fractures.
  • The reviewers asked the researchers why upper-extremity fractures were excluded from the closed-fracture trial but included in the open-fracture trial. The researchers explained that upper-extremity closed fractures were much less likely to be associated with surgical site infections, so including patients with these fractures in the study would lower the baseline infection risk and potential study power. The researchers also noted that their decision was justified because the results for upper-extremity fractures were likely to be similar to the results from the study of lower-extremity fractures.
  • The reviewers asked whether the predicted effect sizes (36% odds reduction for the closed-fracture study and 38% odds reduction for the open-fracture study) were based on previous data or experience. The researchers confirmed that their effect size estimates were based on a previous trial and added that citation to the report.

Conflict of Interest Disclosures

Project Information

Gerard P. Slobogean, MD, MPH
University of Maryland, Baltimore
$11,296,371
PREPARE: Pragmatic Randomized Trial Evaluating Preoperative Antiseptic Skin Solutions in Fractured Extremities

Key Dates

September 2017
February 2024
2017
2024

Study Registration Information

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Last updated: February 23, 2024