Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
United States, Canada312 participantsStarted 2023-11-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients 18 years of age or older.
. Severe open tibia fracture requiring more than one irrigation and debridement procedure to treat the open fracture.
. Planned internal or external fixation for definitive fracture management.
. Formal surgical debridement within 72 hours of their injury.
. Will have all planned fracture care surgeries performed by a participating surgeon or delegate.
. Informed consent obtained.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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).
. Medical contraindication to antibiotic beads, including previously known allergies or sensitivities to vancomycin and/or tobramycin.
. 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.
. Received previous surgical debridement or management of their fracture at a non-participating hospital or clinic (as applicable).
. Chronic or acute infection at or near the fracture site at the time of initial fracture surgery.
. Incarceration.
. Women of child-bearing potential who are pregnant or intending to become pregnant within the next 6 months.
. Currently enrolled in a study that does not permit co-enrollment.