Infection and Nonunion Rates in Open Fractures: Description of 6,042 Fractures from the FLOW and PREP-IT Trials

Area of Science:

• Orthopaedic Surgery
• Trauma Care
• Infectious Disease Epidemiology

Background:

• Open fractures frequently lead to surgical site infection (SSI) and nonunion.
• Historical infection and nonunion rates vary widely (2%–52% and 12%–17%).

Purpose of the Study:

• To report SSI and delayed union/nonunion rates in a large patient cohort from prospective clinical trials.
• To stratify complication rates using established fracture classification systems.

Main Methods:

• Descriptive analysis of data from the FLOW, Aqueous-PREP, and PREPARE-Open studies.
• Stratification of SSI and delayed union/nonunion rates by Gustilo-Anderson and OTA/AO classifications.
• Kaplan-Meier estimators and log-log transformation for rate estimation and confidence intervals.

Main Results:

• Cumulative 12-month SSI rates ranged from 5.1% (Type 1) to 28.9% (Type 3B).
• Cumulative 12-month delayed union/nonunion rates ranged from 3.0% (Type 1) to 17.0% (Type 3C).
• For Gustilo-Anderson type 3B open tibial shaft fractures (OTA/AO 42), 12-month SSI and nonunion rates were 34.7% and 18.4%, respectively.

Conclusions:

• Open fractures present significant challenges with persistent high rates of SSI and nonunion at one year.
• Current treatment strategies have not substantially improved outcomes compared to historical data.
• These findings are crucial for prognosis, research design, and informing public health policy regarding open fracture management.