Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy

NCT05615844

RecruitingPhase 3

Sponsor: University of Maryland, Baltimore

Conditions: Open tíbia Fracture

Interventions: Antibiotic Cement Bead Pouch, Negative Pressure Wound Therapy

Countries: United States, Canada

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (34)
  • Chandler, Arizona, United States
  • Tucson, Arizona, United States
  • Davis, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Orange, California, United States
  • New Haven, Connecticut, United States
  • Gainesville, Florida, United States
  • Miami, Florida, United States
  • Indianapolis, Indiana, United States
  • Baltimore, Maryland, United States
  • Largo, Maryland, United States
  • Boston, Massachusetts, United States
  • University, Mississippi, United States
  • Lincoln, Nebraska, United States
  • Las Vegas, Nevada, United States
  • Lebanon, New Hampshire, United States
  • Fargo, North Dakota, United States
  • Cincinnati, Ohio, United States
  • Cincinnati, Ohio, United States
  • Eugene, Oregon, United States
  • Portland, Oregon, United States
  • Bethlehem, Pennsylvania, United States
  • Columbia, South Carolina, United States
  • Greenville, South Carolina, United States
  • Sioux Falls, South Dakota, United States
  • Salt Lake City, Utah, United States
  • Falls Church, Virginia, United States
  • Madison, Wisconsin, United States
  • New Westminster, British Columbia, Canada
  • + 4 more on CT.gov