Comparing Faster Versus Standard Timing of Flap Surgery for Severe Lower Leg Injuries Below the Knee

What this Trial Is About

Researchers are evaluating whether accelerated flap coverage within 72 hours of injury reduces infection-related complications compared to standard flap coverage timing in patients with severe open fractures andor dislocations below the knee. This randomized controlled trial addresses an important uncertainty in care for these injuries, aiming to provide clear evidence to guide treatment timing and improve patient outcomes. The study includes adult patients 18 years and older who require acute flap coverage for their injury. Participants will be randomly assigned to receive either flap surgery within 72 hours of injury or flap surgery at the standard timing practiced at their medical center. The choice of flap type and management after surgery will be decided by the treating surgeons and recorded. Both groups will have their fracture or dislocation managed according to usual care. Follow-up visits are scheduled at 6 weeks, 3 months, 6 months, and 12 months after randomization to monitor progress. During the study, researchers will assess a combined primary outcome at 6 months that includes overall survival, limb amputation due to injury, re-operations for infection or flap issues, and days spent in acute hospital care. Secondary outcomes include these individual measures at 6 and 12 months, as well as patient-reported quality of life and satisfaction. Safety events will be reviewed regularly by a monitoring committee to ensure participant well-being throughout the trial.

Accelerated Flap Coverage in Severe Lower Extremity Trauma