Trials / Terminated
TerminatedNCT03705962
Locally Applied Antibiotics for Infection Prophylaxis in Treatment of Open Fractures
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- University of Virginia · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tobramycin | |
| OTHER | Placebo: normal saline |
Timeline
- Start date
- 2015-07-01
- Primary completion
- 2019-03-07
- Completion
- 2019-03-07
- First posted
- 2018-10-15
- Last updated
- 2023-06-15
- Results posted
- 2023-06-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03705962. Inclusion in this directory is not an endorsement.