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NCT03560232 · ClinicalTrials.gov registry record · Phase 4
Noninferiority Comparison of Prophylactic Open Fracture Antimicrobial Regimens
A Phase 4 study, sponsored by Mercy Health Ohio.
- Terminated
- Registry status
- Phase 4
- Development phase
- 17
- Enrollment target
NCT03560232: Clinical Trial Phase 4 study, sponsored by Mercy Health Ohio.
NCT03560232 is a Phase 4 study that was terminated before completion, run by Mercy Health Ohio. The registered enrollment target is 17 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03560232, a Phase 4 study, was terminated before completion, sponsored by Mercy Health Ohio.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 17 participants
- Enrollment target
Study Summary
To demonstrate noninferiority of three different empiric antimicrobial regimens compared to the traditional antimicrobial regimen for the management of grade III open fractures as well as evaluate outcomes among these groups.
Primary Outcome
The primary outcome for this study is the number of post-surgical site wound infections, defined as initiation of antibiotics for surgical-site infection and/or need for surgical debridement of site. The acceptable infection rate per Trauma Practice Management Guidelines states a rate less than 20%.
Interventions
- DRUG Ceftriaxone
- DRUG Piperacillin/tazobactam
- DRUG Ampicillin/sulbactam
- DRUG Cefazolin + Gentamicin
- DRUG Clindamycin + Gentamicin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2018-07-09 |
| Est. Completion | 2020-02-19 |
| Phase | Phase 4 |
Why NCT03560232 stopped before completion
NCT03560232 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 5 interventions - of which Ceftriaxone is the first listed.
NCT03560232 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03560232 about?
NCT03560232 is a clinical study titled "Noninferiority Comparison of Prophylactic Open Fracture Antimicrobial Regimens". To demonstrate noninferiority of three different empiric antimicrobial regimens compared to the traditional antimicrobial regimen for the management of grade III open fractures as well as evaluate outcomes among these groups.
What is the current status of trial NCT03560232?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 17 participants. The study started on 2018-07-09. Estimated completion is 2020-02-19.
What interventions are being tested in trial NCT03560232?
The interventions under investigation include: Ceftriaxone (DRUG), Piperacillin/tazobactam (DRUG), Ampicillin/sulbactam (DRUG), Cefazolin + Gentamicin (DRUG), Clindamycin + Gentamicin (DRUG).
Who is sponsoring clinical trial NCT03560232?
This trial is sponsored by Mercy Health Ohio, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03560232's enrollment target sits among peer trials
17 1854th of 2000 higher than 132 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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