Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy

• Status: Not yet recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: All

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 2 weeks, 6 weeks, 3 months, and 6 months post-surgery. The primary outcome will be clinical status 6 months after randomization as assessed with an ordinal scale. The scale consists of the following categories: 1) all-cause mortality, 2) amputation at the fracture location, 3) unplanned reoperation to manage wound complications, an infection, or promote fracture healing, and 4) clinical fracture healing 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland, Baltimore
• Collaborator: McMaster University
• Treatments: Anti-Bacterial Agents

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. Medical contraindication to antibiotic beads.

2. 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.

3. Received previous surgical debridement or management of their fracture at a non-participating hospital or clinic (as applicable).

4. Chronic or acute infection at or near the fracture site at the time of initial fracture surgery.

5. Incarceration.

6. Women of child-bearing potential who are pregnant or intending to become pregnant within the next 6 months.

7. Currently enrolled in a study that does not permit co-enrollment.

8. Unable to obtain informed consent due to language barriers.

9. Likely problems, in the judgment of research personnel, with maintaining follow-up with the patient.

10. Prior enrollment in the trial

11. Other reason to exclude patient, as approved by the Methods Centre