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Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy

ConditionOpen tíbia Fracture
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Maryland, Baltimore

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients 18 years of age or older.

Severe open tibia fracture requiring more than one irrigation and debridement procedure to treat the open fracture.

Planned internal or external fixation for definitive fracture management.

Formal surgical debridement within 72 hours of their injury.

Disqualifiers

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).

Medical contraindication to antibiotic beads, including previously known allergies or sensitivities to vancomycin and/or tobramycin.

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.

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Antibiotic Cement Bead Pouch

    Drug

    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.

  • Negative Pressure Wound Therapy

    Device

    Standard application of negative pressure wound therapy

Treatment groups

312 Participants
are divided into 2 treatment groups
Group A: Antibiotic Cement Bead PouchExperimental treatment 1 intervention
Group B: Negative Pressure Wound Therapy (NPWT)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical status

Clinical status is a hierarchal composite of the following outcomes: i) all-cause mortality ii) amputation at the fracture location iii) unplanned reoperation to manage wound complications, an infection, or promote fracture healing, iv) clinical fracture healing assessed using the Functional IndeX for Trauma (FIX-IT) instrument.

Time frame
6 months

Secondary outcomes

1

Mortality

All-cause mortality

Time frame
6 months
2

Amputation

Injury-related amputation of the lower extremity

Time frame
6 months
3

Unplanned reoperation(s)

Unplanned reoperation to manage wound complications, an infection, or promote fracture healing.

Time frame
6 months
4

Clinical fracture healing

Clinical fracture healing assessed using the Functional IndeX for Trauma (FIX-IT) instrument.

Time frame
6 months

Other outcomes

Sponsors and contacts

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University of Maryland, Baltimore

Lead sponsor

McMaster University

Collaborator

University of California, Irvine

Collaborator

Source ClinicalTrials.gov
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