Grant: Project Grant

This proposal aims to determine whether an antibiotic bead pouch (bead pouch) or negative pressure wound therapy (wound vac) more effectively prevents infections after surgery for severe open tibia (shin bone) fractures. Open fractures represent the most severe orthopaedic injuries and can lead to infection in up to 50% of cases where the wound contains large amounts of debris. To prevent infection and support healing, surgeons must thoroughly clean the wound. This may require multiple surgeries before the wound can be closed. When multiple surgeries are needed, there is uncertainty on how the open wound should be managed between procedures. The wound vac is the most common method to temporarily manage these injuries. However, its effectiveness is unclear. Some surgeons instead use the bead pouch. This method has the potential to help prevent infections, reduce the need for intravenous antibiotics, and offer a practical solution in busy hospitals or those with limited resources. A large-scale trial is needed to determine whether the bead pouch leads to better outcomes and should be used more frequently. The proposed trial is an ongoing international randomized controlled trial of 312 adult patients with severe open tibia fractures. Patients are randomly assigned to receive either bead pouch or wound vac treatment and are followed for 6 months. Over 30 clinical sites across Canada, the United States (US), and the United Kingdom (UK) have been carefully selected to take part. To date, 72 patients have been enrolled. Existing funding supports enrollment of 212 patients in the US. To complete the trial, we require CIHR support to enroll 100 patients at hospitals in Canada and the UK. This trial has the potential to improve how we treat open tibia fractures by providing surgeons with stronger evidence to guide their decisions. Support from CIHR will help us share these findings more widely and will promote collaboration among experts in orthopaedic trauma care.