Antibiotic Bead Pouch vs Negative Pressure Therapy for Open Fractures

Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy

Recruiting Phase 3 Interventional Study
Open tíbia Fracture
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
312 (estimated)
Sponsor
University of Maryland, Baltimore · Other
Who this trial is looking for

This trial is looking for adults with a severe open fracture of the tibia that needs multiple surgical treatments. Participants will receive either an antibiotic bead pouch or a special vacuum therapy to help manage their wounds.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am 18 years of age or older.
  • I have a severe open tibia fracture needing multiple surgeries.
  • I have planned surgery for fixing my fracture.
  • I have had surgical cleaning of my injury within 72 hours.
  • All my surgeries will be done by a qualified surgeon.
  • I have given my informed consent.

You may not be able to join if

  • My doctor thinks my limb cannot be saved.
  • I am allergic to vancomycin or tobramycin.
  • I have a medical reason that prevents me from using vacuum therapy.
  • I have had surgery for my fracture at a different hospital.
  • I have an infection at the fracture site.
  • I am currently in prison.
  • I am pregnant or planning to become pregnant soon.
  • I cannot understand the information to give my consent.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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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 mo…
Trial Locations
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Eligibility 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…
Contacts

Heather Phipps, MPS

410-706-2492

hphipps@som.umaryland.edu

CONTACT