Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
A Randomized Controlled Trial Comparing Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy for the Management of Severe Open Tibia Fracture Wounds
University of Maryland, Baltimore
312 participants
Nov 5, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
The antibiotic bead pouch provides an antibiotic delivery mechanism. It is made by combining polymethyl methacrylate (PMMA) cement with generic forms of vancomycin and tobramycin powder.
Standard application of negative pressure wound therapy
Locations(34)
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NCT05615844