Project Summary
This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
What is the research about?
Infections can occur after any surgery. Patients who have surgery to repair a broken bone have a high risk of infection. Infections can lead to more surgery, loss of a limb, or even death. Before performing surgery to repair a fracture, doctors apply an antiseptic solution to the patient’s skin to help prevent infection. However, there are many types of antiseptic solutions. Doctors don’t know what type of antiseptic solution works best to prevent infections after fracture surgery.
In this study, the research team is comparing two common alcohol-based antiseptic solutions in patients having surgery to treat a fracture. The team wants to see whether using either solution is better in preventing infections or unplanned surgeries.
Who can this research help?
Results from this study may help doctors choose between two common types of antiseptic solution when doing fracture surgery.
What is the research team doing?
The research team is working with 10 groups of surgeons to conduct this study. The team is assigning half of the groups by chance to use one antiseptic solution, and the other half to use the second solution. The groups of surgeons use their assigned solution for two months. Then they switch and use the other type of solution for two more months. The research team repeats this process every two months with both groups until patient enrollment is complete. The study includes 1,540 patients with open fractures, or bone breaks through the skin, and 6,280 patients with closed fractures, or fractures where the bone does not break through the skin.
The research team is studying whether either antiseptic solution is better at preventing infections or unplanned fracture surgeries. The team is also looking to see if the solutions work differently for patients with different amounts of damage to their skin or muscles.
Patients, healthcare professionals, and leaders from professional organizations are members of the study team. They are helping to design the study protocol and providing guidance on study procedures.
Research methods at a glance
| Design Elements | Description |
|---|---|
| Design | Cluster randomized crossover trial |
| Population | Patients ages 18 and older with an open fracture or a closed fracture of the lower extremity or pelvis that is managed with a surgical implant |
| Interventions/ Comparators |
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| Outcomes |
Primary: surgical site infection within 3 months of definitive fracture fixation Secondary: unplanned fracture-related reoperation within 12 months of injury |
| 90-day follow-up for primary outcome |