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Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
Sponsor: 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.
Official title: A Randomized Controlled Trial Comparing Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy for the Management of Severe Open Tibia Fracture Wounds
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
312
Start Date
2023-11-05
Completion Date
2027-10-01
Last Updated
2026-03-10
Healthy Volunteers
No
Conditions
Interventions
Antibiotic 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.
Negative Pressure Wound Therapy
Standard application of negative pressure wound therapy
Locations (33)
Dignity Health Chandler Regional Medical Center
Chandler, Arizona, United States
University of California, Davis
Davis, California, United States
University of Southern California
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California, Irvine
Orange, California, United States
Yale University
New Haven, Connecticut, United States
University of Florida
Gainesville, Florida, United States
University of Miami
Miami, Florida, United States
Indiana University
Indianapolis, Indiana, United States
University of Maryland, R Adams Cowley Shock Trauma Center
Baltimore, Maryland, United States
University of Maryland Capital Region Health
Largo, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Mississippi
University, Mississippi, United States
Bryan Medical Center
Lincoln, Nebraska, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Sanford Medical Center
Fargo, North Dakota, United States
University of Cincinnati
Cincinnati, Ohio, United States
Bon Secours Mercy Health
Cincinnati, Ohio, United States
Slocum Center
Eugene, Oregon, United States
Ortegon Health & Science University
Portland, Oregon, United States
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States
Prisma Health - Midlands
Columbia, South Carolina, United States
Prisma Health
Greenville, South Carolina, United States
Sanford Health
Sioux Falls, South Dakota, United States
University of Utah
Salt Lake City, Utah, United States
Inova Fairfax
Falls Church, Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
Royal Columbian Hospital
New Westminster, British Columbia, Canada
University of British Columbia
Vancouver, British Columbia, Canada
Hamilton Health Sciences
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada