Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
Status:
Not yet recruiting
Trial end date:
2025-10-01
Target enrollment:
Participant gender:
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 2 weeks, 6 weeks, 3 months, and 6 months post-surgery. The
primary outcome will be clinical status 6 months after randomization as assessed with an
ordinal scale. The scale consists of the following categories: 1) all-cause mortality, 2)
amputation at the fracture location, 3) unplanned reoperation to manage wound complications,
an infection, or promote fracture healing, and 4) clinical fracture healing 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.