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NCT05615844 · ClinicalTrials.gov registry record · Phase 3
Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
A Phase 3 study of Open tíbia Fracture, sponsored by University of Maryland, Baltimore.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 312
- Enrollment target
- 20
- Study locations
NCT05615844: Recruiting Phase 3 study of Open tíbia Fracture, sponsored by University of Maryland, Baltimore.
NCT05615844 is a Phase 3 study of Open tíbia Fracture that is actively recruiting participants, run by University of Maryland, Baltimore. The registered enrollment target is 312 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05615844, a Phase 3 study of Open tíbia Fracture, is actively recruiting participants, sponsored by University of Maryland, Baltimore.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 312 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Antibiotic Cement Bead Pouch
- DEVICE Negative Pressure Wound Therapy
Study Locations (20)
California
- University of California, Davis - Davis
- University of Southern California - Los Angeles
- Cedars-Sinai Medical Center - Los Angeles
- University of California, Irvine - Orange
Florida
- University of Florida - Gainesville
- University of Miami - Miami
Maryland
- University of Maryland, R Adams Cowley Shock Trauma Center - Baltimore
- University of Maryland Capital Region Health - Largo
Ohio
- University of Cincinnati - Cincinnati
- Bon Secours Mercy Health - Cincinnati
Arizona
- Dignity Health Chandler Regional Medical Center - Chandler
Connecticut
- Yale University - New Haven
Indiana
- Indiana University - Indianapolis
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 312 participants |
| Start Date | 2023-11-05 |
| Est. Completion | 2027-10-01 |
| Phase | Phase 3 |
What NCT05615844 shows while recruiting
NCT05615844 is an interventional study that assigns participants to a tested intervention. The registered 312 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower).
The record links to 1 condition, with Open tíbia Fracture appearing as the primary indexed condition, and to 2 interventions - of which Antibiotic Cement Bead Pouch is the first listed.
NCT05615844 names 20 study sites across 14 states, led by California, Florida, Maryland.
Frequently Asked Questions
What is clinical trial NCT05615844 about?
NCT05615844 is a clinical study titled "Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy". 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 (...
What is the current status of trial NCT05615844?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 312 participants. The study started on 2023-11-05. Estimated completion is 2027-10-01.
What conditions does trial NCT05615844 study?
This clinical trial studies the following conditions: Open tíbia Fracture.
What interventions are being tested in trial NCT05615844?
The interventions under investigation include: Antibiotic Cement Bead Pouch (DRUG), Negative Pressure Wound Therapy (DEVICE).
Who is sponsoring clinical trial NCT05615844?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05615844 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05615844's enrollment target sits among peer trials
312 1103rd of 2000 higher than 895 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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