Condition: Open tíbia Fracture · Sponsor: University of Maryland, Baltimore
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.
This description comes directly from the study's public registry record.
Heather Phipps, MPS · 410-706-2492 · hphipps@som.umaryland.edu
Always discuss trial participation with your own doctor first.
| Dignity Health Chandler Regional Medical Center | Chandler, Arizona, United States | Recruiting |
| University of Arizona | Tucson, Arizona, United States | Recruiting |
| University of California, Davis | Davis, California, United States | Recruiting |
| University of Southern California | Los Angeles, California, United States | Recruiting |
| Cedars-Sinai Medical Center | Los Angeles, California, United States | Recruiting |
| University of California, Irvine | Orange, California, United States | Recruiting |
| Yale University | New Haven, Connecticut, United States | Recruiting |
| University of Florida | Gainesville, Florida, United States | Recruiting |
| University of Miami | Miami, Florida, United States | Recruiting |
| Indiana University | Indianapolis, Indiana, United States | Recruiting |
| University of Maryland, R Adams Cowley Shock Trauma Center | Baltimore, Maryland, United States | Recruiting |
| University of Maryland Capital Region Health | Largo, Maryland, United States | Recruiting |
+ 22 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05615844