Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
United States312 participantsStarted 2023-11-05
Plain-language summary
The Beads vs Vac trial is a multi-centre randomized controlled trial of 312 participants with a severe open tibia fracture requiring multiple irrigation and debridement surgeries. Eligible participants will be randomized to receive either an antibiotic bead pouch or negative pressure wound therapy (NPWT) for their temporary open fracture wound management. Outcomes will be assessed at 6 weeks, 3 months, and 6 months post-surgery. The primary outcome will be a composite outcome to evaluate clinical status six months after randomization. Components of the composite outcome will be hierarchically assessed in the following order: 1) all-cause mortality, 2) injury-related amputation of the lower extremity, 3) unplanned reoperation to manage wound complications, infection, or delayed fracture healing, and 4) clinical fracture healing as assessed using the Functional IndeX for Trauma (FIX-IT) instrument. The secondary outcomes will independently assess the four components of the primary outcome. This is a Phase III trial.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients 18 years of age or older.
✓. Severe open tibia fracture requiring more than one irrigation and debridement procedure to treat the open fracture.
✓. Planned internal or external fixation for definitive fracture management.
✓. Formal surgical debridement within 72 hours of their injury.
✓. Will have all planned fracture care surgeries performed by a participating surgeon or delegate.
✓. Informed consent obtained.
Exclusion criteria
✕. Due to the severity of injury, the treating surgeon does not believe limb salvage \>6 months is likely to be successful based on the emergency department or initial intraoperative assessment (prior to enrolment and randomization).
✕. Medical contraindication to antibiotic beads, including previously known allergies or sensitivities to vancomycin and/or tobramycin.
✕. Medical or injury contraindication to NPWT. Injury contraindications could include situations in which the NPWT could not be placed over a vascular graft or exposed neurovascular structure.