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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 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. The trial reports 20 study locations across 14 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05615844
The ClinicalTrials.gov registry entry for NCT05615844 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 312 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.
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