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Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy

NCT05615844 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

  • Open tíbia Fracture

Interventions

DRUG

Antibiotic Cement Bead Pouch

The antibiotic bead pouch provides an antibiotic delivery mechanism. It is made by combining polymethyl methacrylate (PMMA) cement with generic forms of vancomycin and tobramycin powder.

DEVICE

Negative Pressure Wound Therapy

Standard application of negative pressure wound therapy

Sponsors & Collaborators

  • McMaster University

    collaborator OTHER

  • University of California, Irvine

    collaborator OTHER

  • University of Maryland, Baltimore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-05
Primary Completion
2027-03-31
Completion
2027-10-01
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05615844 on ClinicalTrials.gov