Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy

Launched by UNIVERSITY OF MARYLAND, BALTIMORE · Nov 7, 2022

Keywords

ClinConnect Summary

The Beads vs Vac trial is a clinical study looking at two different ways to manage severe open tibia fractures, which are serious injuries to the shinbone that may require multiple surgeries to clean and treat. This trial involves 312 participants who will be randomly assigned to receive either an antibiotic bead pouch, which helps prevent infection, or negative pressure wound therapy (NPWT), which helps heal wounds by applying gentle suction. Researchers will follow the participants for six months after their surgeries to see how well each treatment works, with key factors including overall health, risk of amputation, need for further surgeries, and how well the fracture heals.

To be eligible for this trial, participants must be at least 18 years old with a severe open tibia fracture that needs more than one cleaning surgery. They should also have a plan for fixing the fracture in the future and must have had initial surgery within 72 hours of their injury. People who have certain medical conditions, have had previous surgeries for their fracture elsewhere, or are pregnant are not eligible. Those who join the trial can expect regular follow-ups at 6 weeks, 3 months, and 6 months to assess their recovery and the effectiveness of the treatments.

Gender

ALL

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.