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NCT01714596 · ClinicalTrials.gov registry record · NA
Randomized Trial to Assess PO Versus IV Antibiotics
A NA study of Wound Infection, sponsored by Major Extremity Trauma Research Consortium.
- Completed
- Registry status
- NA
- Development phase
- 233
- Enrollment target
- 20
- Study locations
NCT01714596 is a NA study of Wound Infection that has completed, run by Major Extremity Trauma Research Consortium. The registered enrollment target is 233 participants, below the 355-participant average among 10 other Wound Infection trials with a reported enrollment target (34% lower). The trial reports 20 study locations across 17 states.
The verdict
NCT01714596, a NA study of Wound Infection, has completed, sponsored by Major Extremity Trauma Research Consortium.
- COMPLETED
- Registry status
- NA
- Development phase
- 233 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- OTHER PO versus IV antibiotics Route of administration evaluation
Study Locations (20)
California
- Cedars Sinai Medical Center - Los Angeles
- University of California at San Francisco - San Francisco
New York
- Jamaica Hospital Medical Center - Jamaica
- NYU Langone Medical Center - New York
North Carolina
- Carolinas Medical Center - Charlotte
- Wake Forest Baptist Medical Center - Winston-Salem
Alabama
- University of Alabama at Birmingham - Birmingham
Colorado
- Denver Health and Hospital Authority - Denver
Florida
- University of Miami Ryder Trauma Center - Miami
Indiana
- Eskenazi Health - Indianapolis
Iowa
- University of Iowa Hospitals & Clinics - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 233 participants |
| Start Date | 2013-12-03 |
| Est. Completion | 2020-12-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01714596
The ClinicalTrials.gov registry entry for NCT01714596 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 233 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 355-participant average among 10 other Wound Infection trials with a reported enrollment target (34% lower). The listed sponsor is Major Extremity Trauma Research Consortium, which has 30 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Wound Infection appearing as the primary indexed condition, and to 1 intervention - of which PO versus IV antibiotics Route of administration evaluation is the first listed.
NCT01714596 reports 20 study locations spanning 17 distinct geographic areas - top geographies include California, New York, North Carolina.
Frequently Asked Questions
What is clinical trial NCT01714596 about?
NCT01714596 is a clinical study titled "Randomized Trial to Assess PO Versus IV Antibiotics". 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. Prim...
What is the current status of trial NCT01714596?
This trial is currently completed. It is a NA study. The enrollment target is 233 participants. The study started on 2013-12-03. Estimated completion is 2020-12-30.
What conditions does trial NCT01714596 study?
This clinical trial studies the following conditions: Wound Infection.
What interventions are being tested in trial NCT01714596?
The interventions under investigation include: PO versus IV antibiotics Route of administration evaluation (OTHER).
Who is sponsoring clinical trial NCT01714596?
This trial is sponsored by Major Extremity Trauma Research Consortium, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01714596 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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