Randomized Trial to Assess PO Versus IV Antibiotics
Public ClinicalTrials.gov record NCT01714596. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective Randomized Trial to Assess PO Versus IV Antibiotics for the Treatment of Post-op Wound Infection After Extremity Fractures (POvIV)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The goal of this study is to evaluate the effect of treatment of post-op wound infection in long bones after fracture fixation or joint fusion and either: (Group 1) operative debridement and PO antibiotic treatment for 6 weeks; or (Group 2) operative debridement and IV antibiotics for 6 weeks. Primary Hypothesis 1: The rate of study injury related surgical interventions by one year in Group 1 will be non-inferior to the rate in Group 2. Secondary Hypothesis 1: The rate of treatment failure by one year in Group 1 will be non-inferior to the rate in Group 2. Treatment failure is defined as wound problems that require surgery \>2 weeks after initial debridement, infection recurrence, infection with a new pathogen, joint erosion, implant failure, medical problems related to the treatment administration which necessitates a switch from one arm to the other. Secondary Hypothesis 2: The rate of re-hospitalization for complications, infection, non-union and amputation by one year in Group 1 will be non-inferior to the rate in Group 2. Secondary Hypothesis 3: Following discharge for treatment of infection, per patient treatment costs at 1 year will be lower in Group 1 than in Group 2. Secondary Hypothesis 4: Adherence in Group 1 will be non-inferior to adherence in Group 2. Secondary Hypothesis 5: Patient satisfaction with treatment in Group 1 will be non-inferior to adherence in Group 2. Specific Aim 2: To build and validate a risk prediction model for failure of treatment of early post-op wound infections after fixation of fractures and joint fusions.
Study identification
- NCT ID
- NCT01714596
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 233 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 84 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 2, 2013
- Primary completion
- Sep 29, 2019
- Completion
- Dec 29, 2020
- Last update posted
- Feb 10, 2021
2013 – 2020
United States locations
- U.S. sites
- 24
- U.S. states
- 19
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | — | — |
| Cedars Sinai Medical Center | Los Angeles | California | — | — |
| University of California at San Francisco | San Francisco | California | — | — |
| Denver Health and Hospital Authority | Denver | Colorado | — | — |
| University of Miami Ryder Trauma Center | Miami | Florida | — | — |
| Eskenazi Health | Indianapolis | Indiana | — | — |
| University of Iowa Hospitals & Clinics | Iowa City | Iowa | — | — |
| University of Maryland R Adams Cowley Shock Trauma Center | Baltimore | Maryland | — | — |
| Boston Medical Center | Boston | Massachusetts | — | — |
| Hennepin County Medical Center | Minneapolis | Minnesota | — | — |
| St. Louis University Medical Center | St Louis | Missouri | — | — |
| Jamaica Hospital Medical Center | Jamaica | New York | — | — |
| NYU Langone Medical Center | New York | New York | — | — |
| Carolinas Medical Center | Charlotte | North Carolina | — | — |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | — | — |
| MetroHealth Medical Center | Cleveland | Ohio | — | — |
| Penn State University M.S. Hershey Medical Center | Hershey | Pennsylvania | — | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| San Antonio Military Medical Center (SAMMC) | San Antonio | Texas | — | — |
| University of Virginia | Charlottesville | Virginia | — | — |
| Inova Fairfax Hospital | Falls Church | Virginia | — | — |
| Naval Medical Center Portsmouth | Portsmouth | Virginia | — | — |
| University of Washington/Harborview Medical Center | Seattle | Washington | — | — |
| University of Wisconsin | Madison | Wisconsin | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01714596, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 10, 2021 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01714596 live on ClinicalTrials.gov.