Comparing Antibiotic Cement Bead Pouch and Negative Pressure Wound Therapy for Treating Severe Open Tibia Fracture Wounds in Adults

What this Trial Is About

Researchers are evaluating wound management methods for adults with severe open tibia fractures requiring multiple irrigation and debridement surgeries. This Phase III trial compares an antibiotic cement bead pouch to negative pressure wound therapy NPWT to see which better reduces complications. The study addresses uncertainty about the best temporary wound care between surgeries and aims to fill gaps in knowledge about these two approaches. Participants will be randomly assigned to one of two groups. One group receives an antibiotic bead pouch where antibiotic-laden cement beads are placed in the wound and sealed with a dressing. Beads may be replaced during subsequent surgeries. The other group receives NPWT, a sealed dressing connected to a vacuum pump that removes fluid and promotes healing. NPWT settings and changes are managed by the surgeon, typically every 24-72 hours until final fracture treatment. Participants will be followed for six months with assessments at 6 weeks, 3 months, and 6 months after surgery. Researchers will evaluate a composite outcome including mortality, amputation, unplanned reoperations, and fracture healing using the Functional IndeX for Trauma FIX-IT tool. Safety events and outcomes will be reviewed by committees. The total study duration for each participant spans these follow-up periods to monitor healing and complications.

Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy