Antibiotic Beads vs Negative Pressure Therapy for Open Tibia Fracture (BeadsvsVac Trial)

Phase 3

Recruiting

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare two wound healing treatments for people with severe open tibia fractures. Outcomes will be assessed at 6 weeks, 3 months, and 6 months after surgery. The primary outcome is a composite outcome to evaluate clinical status 6 months after randomization.

Who is the study for?

This trial is for adults over 18 with severe open tibia fractures needing multiple cleanings and debridement surgeries. They must plan to have internal or external fixation, receive initial surgery within 72 hours of injury, and all procedures done by a participating surgeon.

What is being tested?

The study compares two treatments for managing temporary wounds in severe open tibia fractures: an antibiotic cement bead pouch versus negative pressure wound therapy (NPWT). Participants are randomly assigned to one of the treatments and followed up at several intervals post-surgery.

What are the potential side effects?

Potential side effects may include irritation or allergic reactions from the antibiotic beads, complications like infection from either treatment method, discomfort associated with NPWT device use, and possible issues related to wound healing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical status

Secondary study objectives

Amputation

Clinical fracture healing

Mortality

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Antibiotic Cement Bead PouchExperimental Treatment1 Intervention

The antibiotic cement bead pouch involves placing temporary non-absorbable antibiotic-laden cement beads into the open fracture wound and sealing the wound with a large occlusive dressing for prophylaxis against bacteria. The antibiotic beads used will be prepared intraoperatively by the surgical team. The bead recipe will be comprised of a ratio of 2 grams of vancomycin, 2.4 grams of tobramycin, and 40g (one bag) of PMMA cement. The beads will be handmade and approximately 10-mm in diameter. The number of beads placed in the wound will be at the discretion of the treating surgeon based on recipient wound size. As commonly practiced, the antibiotic beads may be exchanged for new beads at each subsequent irrigation and debridement surgery. The number of beads, the number of replaced beads, and the removal of the antibiotic beads will be recorded.

Group II: Negative Pressure Wound Therapy (NPWT)Active Control1 Intervention

The NPWT system is a sealed dressing placed over the open fracture wound that includes an occlusive plastic wound dressing connected to a vacuum pump, tubing, and a canister to collect fluid. The pump creates a vacuum seal and exerts negative pressure on the wound to remove fluid and maintain a sealed environment. NPWT promotes wound healing through four primary mechanisms: 1) wound shrinkage or macrodeformation; 2) microdeformation at the foam-wound surface interface; 3) fluid removal; and 4) stabilization of the wound environment. 125 mmHg continuous negative pressure is the recommended NPWT device setting; however, the treating surgeon will be allowed to adjust these settings as clinically necessary. The frequency and timing of NPWT changes will also be at the surgeon's discretion but is expected to primarily coincide with the timing of repeat debridement, typically every 24-72 hours until definitive management has occurred.

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