Accelerated Flap Coverage Versus Standard Timing in the Treatment of Severe Lower Extremity Musculoskeletal Injuries

About This Grant

In the United States (US), there are more than 300,000 lower extremity musculoskeletal injuries each year. In patients with severe injuries, 20-40% will develop an infection. Patients at highest risk for infection have open injuries where the bone breaks through the skin causing skin and muscle damage that require soft tissue reconstruction with a flap. A flap is vascularized tissue that is moved from one area of the patient's body to the injury site to reconstruct the damaged soft tissues. Prior studies have optimized many aspects of lower extremity trauma care for severe injuries. Despite extensive prior work, the timing of the flap surgery has not been rigorously evaluated. In the US, the mean time from injury to flap surgery is 10 days and infection rates are 20- 40%. There is evidence to suggest that an alternative approach of early flap coverage might reduce the risk of infection. Studies have shown that when the time between injury and the flap surgery was 72 hours or less, infection rates were reduced. Mechanistically, this makes sense. Faster soft tissue reconstruction of the open wound requires early high-quality debridement at specialized centers and leads to early antibiotic delivery and the prevention of nosocomial contamination. The existing data and this rationale led the United Kingdom (UK) to develop guidelines for early flap coverage. Following guideline implementation, infection rates dropped to less than 10%. Despite this success, practice outside of the UK has not changed. We believe this is due to inadequate evidence to motivate surgeons and hospitals to mobilize the resources required to change the time to flap from 10 days to less than 72 hours. Resources required include timely transport of patients to specialized centers and a re-prioritization of operating room and surgeon availability. In existing studies, the time from injury to flap is highly influenced by several confounding factors, namely, injury severity and practice environment which are not adequately controlled for in non-randomized studies. While the existing retrospective and non-comparative data are promising, given the resources required to change, higher quality evidence is needed. The proposed trial will address this knowledge gap. This is an international randomized controlled trial of 356 patients with severe fractures and/or dislocations below the knee that require flap surgery for initial injury management. Patients will be randomized 1:1 to accelerated flap surgery within 72 hours of injury versus standard of care flap surgery timing. The trial's overarching objective is to determine if accelerated flap timing reduces infection. The primary outcome is a 6-month composite clinical status outcome, hierarchically assessed as: 1) mortality, 2) amputation, 3) re-operation, and 4) days in the hospital. This trial will test three specific aims: 1) to determine if accelerated flap surgery leads to improved clinical status at 6 months, 2) to determine if accelerated flap surgery leads to improved clinical status at 12 months, leads to improvements in the individual components of the composite outcome at 6- and 12-months, and 3) to determine if accelerated flap surgery improves quality of life over 6 months and over 12 months.