Antibiotic Cement Bead Pouch vs. Negative Pressure Wound TherapyAntibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy

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.