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
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.
Description
The primary objective of early open fracture management is to minimize the risk of complications. In severe cases, multiple irrigation and debridement surgeries are required to overcome the severe wound contamination, to reassess the evolving tissue injury, and/or to temporize and plan appropriate soft tissue coverage with a skin graft or muscle flap. When multiple irrigation and debridement surgeries are needed, there is uncertainty on how the open fracture wound should be managed between procedures. Negative pressure wound therapy (NPWT), commonly known as a Wound VAC, is the preferred metho…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
The inclusion criteria are: 1. Patients 18 years of age or older. 2. Severe open tibia fracture requiring more than one irrigation and debridement procedure to treat the open fracture. 3. Planned internal or external fixation for definitive fracture management. 4. Formal surgical debridement within 72 hours of their injury. 5. Will have all planned fracture care surgeries performed by a participating surgeon or delegate. 6. Informed consent obtained. The exclusion criteria are: 1. Due to the severity of injury, the treating surgeon does not believe limb salvage \>6 months is likely to be su…
Interventions
- DrugAntibiotic Cement Bead Pouch
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.
- DeviceNegative Pressure Wound Therapy
Standard application of negative pressure wound therapy
Locations (34)
- Dignity Health Chandler Regional Medical CenterChandler, Arizona
- University of ArizonaTucson, Arizona
- University of California, DavisDavis, California
- University of Southern CaliforniaLos Angeles, California
- Cedars-Sinai Medical CenterLos Angeles, California
- University of California, IrvineOrange, California