RECRUITING Phase 3 ClinicalTrials.gov

Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy

Sponsor: University of Maryland, Baltimore • ClinicalTrials.gov ID: NCT05615844

Registry updated: 2026-09-14

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

Antibiotic Cement Bead Pouch (Drug)
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 (Device)
Standard application of negative pressure wound therapy

Eligibility criteria

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 successful based on the emergency department or initial intraoperative assessment (prior to enrolment and randomization). 2. Medical contraindication to antibiotic beads, including previously known allergies or sensitivities to vancomycin and/or tobramycin. 3. Medical or injury contraindication to NPWT. Injury contraindications could include situations in which the NPWT could not be placed over a vascular graft or exposed neurovascular structure. 4. Received previous surgical debridement or management of their fracture at a non-participating hospital or clinic (as applicable). 5. Chronic or acute infection at or near the fracture site at the time of initial fracture surgery. 6. Incarceration. 7. Women of child-bearing potential who are pregnant or intending to become pregnant within the next 6 months. 8. Currently enrolled in a study that does not permit co-enrollment. 9. Unable to obtain informed consent due to language barriers. 10. Anticipated problems, in the judgment of research personnel, with maintaining follow-up with the patient. 11. Prior enrollment in the trial. 12. Other reason to exclude the patient, as approved by the Methods Center.

Conditions

Open tíbia Fracture

Locations

Dignity Health Chandler Regional Medical Center — Chandler, Arizona, United States
University of Arizona — Tucson, 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 Florida Health Jacksonville — Jacksonville, 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

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment