Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
Recruiting now · Phase 3
Conditions studied: Open tíbia Fracture
In brief
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.
Key facts
- Study ID
- NCT05615844
- Run by
- University of Maryland, Baltimore
- People needed
- 312
- Starts
- 2023-11-05
- Expected to finish
- 2027-10-01
- Last updated by the study team
- 2026-05-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- The Ottawa Hospital — Ottawa, Ontario, Canada (enrolling)
- University of Arizona — Tucson, Arizona, United States (enrolling)
- University of California, Davis — Davis, California, United States (enrolling)
- University of Southern California — Los Angeles, California, United States (enrolling)
- Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
- University of California, Irvine — Orange, California, United States (enrolling)
- Yale University — New Haven, Connecticut, United States (enrolling)
- University of Florida — Gainesville, Florida, United States (enrolling)
- University of Miami — Miami, Florida, United States (enrolling)
- Indiana University — Indianapolis, Indiana, United States (enrolling)
- University of Maryland, R Adams Cowley Shock Trauma Center — Baltimore, Maryland, United States (enrolling)
- University of Maryland Capital Region Health — Largo, Maryland, United States (enrolling)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
- University of Mississippi — University, Mississippi, United States (enrolling)
- Bryan Medical Center — Lincoln, Nebraska, United States (enrolling)
- London Health Sciences Centre — London, Ontario, Canada (enrolling)
- Dignity Health Chandler Regional Medical Center — Chandler, Arizona, United States (enrolling)
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (enrolling)
- Sanford Medical Center — Fargo, North Dakota, United States (enrolling)
- University of Cincinnati — Cincinnati, Ohio, United States (enrolling)
- Bon Secours Mercy Health — Cincinnati, Ohio, United States (enrolling)
- Slocum Center — Eugene, Oregon, United States (enrolling)
- Ortegon Health & Science University — Portland, Oregon, United States (enrolling)
- St. Luke's University Health Network — Bethlehem, Pennsylvania, United States (enrolling)
- Prisma Health - Midlands — Columbia, South Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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