Grant: Project Grant

This proposal is testing a strategy (early flap timing) to prevent infections that occur following severe fractures and dislocations of the bones in the legs. Patients at highest risk for infection have severe wounds of the skin and muscle from the injury that require reconstruction with a flap. A flap is a piece of the patient's own tissue, typically skin or muscle, that is surgically moved from one area of the patient's body to the injury site to cover the wound. Infection rates in injuries severe enough to require a flap are 20-40%. Prior studies have optimized many aspects of care following these injuries; however, the impact of flap timing has not been rigorously evaluated. On average flap surgery is performed 10 days after the injury. In contrast to current practice, an alternative approach of a flap within 72 hours of injury has been shown to reduce infection rates to less than 10%. However, despite preliminary evidence and scientific rationale to support this early flap surgery, prior studies have not been rigorous enough to change clinical practice. Due to the level of resources required to reduce the timing of the flap surgery from 10 days to less than 72 hours, higher quality evidence is needed. The objective of this trial is to determine if flap surgery within 72 hours, compared to standard of care flap surgery timing (5-15 days at participating sites), reduces infection in patients with severe fractures and/or dislocations below the knee. The proposed trial is an international, randomized controlled trial of 356 adult patients that will be performed at 30 hospitals in Canada, the US, Europe, and Australia. Patients will be randomized 1:1 to flap surgery within 72 hours of injury versus standard of care flap surgery timing and followed for 12 months. If this trial successfully demonstrates that early flap surgery reduces infection, this could lead to an international change in flap surgery timing and a worldwide reduction in injury-related infection.