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NCT03705962 · ClinicalTrials.gov registry record · Phase 3
Locally Applied Antibiotics for Infection Prophylaxis in Treatment of Open Fractures
A Phase 3 study, sponsored by University of Virginia.
- Terminated
- Registry status
- Phase 3
- Development phase
- 11
- Enrollment target
NCT03705962: Clinical Trial Phase 3 study, sponsored by University of Virginia.
NCT03705962 is a Phase 3 study that was terminated before completion, run by University of Virginia. The registered enrollment target is 11 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03705962, a Phase 3 study, was terminated before completion, sponsored by University of Virginia.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 11 participants
- Enrollment target
Study Summary
The primary objective of this study is to investigate the effectiveness of local antibiotic versus placebo in the prevention of infections in open fractures. The study will assess whether local treatment of open fractures with the antibiotic tobramycin (in addition to standard systemic antibiotics) will decrease the risk and rate of infection, and rate of re-operation. This will be studied using a randomized controlled clinical trial design in adult population of age 18-70 years who present with open fractures. About 133 subjects will be recruited in this study at UVA.
Primary Outcome
Infection will be defined as major and minor, with major indicated by return to the operating room for irrigation and debridement. Minor infection is represented by documentation of cellulitis or superficial infection at surgical site and administration of oral antibiotics
Interventions
- DRUG Tobramycin
- OTHER Placebo: normal saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2015-07 |
| Est. Completion | 2019-03-07 |
| Phase | Phase 3 |
Why NCT03705962 stopped before completion
NCT03705962 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Tobramycin is the first listed.
NCT03705962 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03705962 about?
NCT03705962 is a clinical study titled "Locally Applied Antibiotics for Infection Prophylaxis in Treatment of Open Fractures". The primary objective of this study is to investigate the effectiveness of local antibiotic versus placebo in the prevention of infections in open fractures. The study will assess whether local treatment of open fractures with the antibiotic tobramycin (in addition to standard systemic antibiotics) ...
What is the current status of trial NCT03705962?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 11 participants. The study started on 2015-07. Estimated completion is 2019-03-07.
What interventions are being tested in trial NCT03705962?
The interventions under investigation include: Tobramycin (DRUG), Placebo: normal saline (OTHER).
Who is sponsoring clinical trial NCT03705962?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03705962's enrollment target sits among peer trials
11 1989th of 2000 higher than 12 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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