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.
Professional Abstract
Objective
To compare the effectiveness of two preoperative antiseptic skin solutions in reducing surgical site infections and unplanned fracture-related reoperations in patients who underwent surgery for fractures
Study Design
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 6,785 adult patients with a surgically treated closed lower extremity or pelvis fracture and 1,700 adult patients with a surgically treated open extremity fracture |
| Interventions/ Comparators |
|
| Outcomes | Primary: superficial surgical site infections within 1 month or deep incisional or organ space surgical site infections within 3 months Secondary: unplanned fracture-related reoperations to treat an infection or wound healing complications or to promote fracture healing |
| Timeframe | Up to 3-month follow-up for primary outcome |
This multiple-period, cluster crossover randomized controlled trial compared the effectiveness of two preoperative antiseptic skin solutions in reducing surgical site infections and unplanned fracture-related reoperations in patients who underwent surgery to treat a closed lower extremity or pelvis fracture or an open extremity fracture.
Researchers randomly assigned hospitals to use one of the two antiseptic solutions—iodine povacrylex in alcohol or chlorhexidine gluconate in alcohol—before surgery for two months. The hospitals then switched to the other antiseptic solution for the next two months and continued switching solutions every two months throughout the study period. Researchers contacted patients directly or reviewed the health records of patients for surgical site infections up to three months after surgery and for unplanned fracture-related reoperations up to one year after surgery.
The study included 8,485 adults who underwent fracture surgery in one of 25 hospitals in the United States and Canada. Of patients with closed fractures, 79% were White, 15% were African American, 4% were Asian, and 1% were Indigenous; race was missing for 1% of these patients. The average age was 54, and 51% were female. Of patients with open fractures, 69% were White, 26% were African American, 2% were Asian, and 1% were Indigenous; race was missing for 1% of these patients. The average age was 45, and 64% were male.
Patients who had experienced surgical complications and infections, clinicians, and members of surgical organizations helped design and conduct the study.
Results
After three months, among patients with closed fractures, 2.4% of patients receiving iodine povacrylex had a surgical site infection versus 3.3% of patients receiving chlorhexidine gluconate (p = 0.049). Among patients with open fractures, the risk of surgical site infection did not differ significantly among patients receiving the two antiseptic solutions.
After one year, the risk of unplanned reoperations did not differ significantly among patients receiving the two antiseptic solutions.
Limitations
Hospitals differed in the number of patients enrolled in the study, which may have limited the researchers’ ability to detect differences between the two solutions.
Conclusions and Relevance
In this study, among patients with closed fractures, the use of iodine povacrylex in alcohol for preoperative skin antisepsis resulted in fewer surgical site infections than the use of chlorhexidine gluconate in alcohol. Among patients with open fractures, the risk of surgical site infection did not differ between the two groups.
Future Research Needs
Future research could compare the effectiveness of the antiseptic skin solutions in reducing infection with other types of surgeries.
Final Research Report
This project's final research report is expected to be available by November 2024.
Engagement Resources
Journal Citations
Results of This Project
Related Journal Citations
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.