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.
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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
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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