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Randomized Trial to Assess PO Versus IV Antibiotics — POvIV  

Wound Infection Clinical Trial

Official title:
A Prospective Randomized Trial to Assess PO Versus IV Antibiotics for the Treatment of Post-op Wound Infection After Extremity Fractures (POvIV)

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01714596
Study type Interventional
Source Major Extremity Trauma Research Consortium
Contact
Status Completed
Phase N/A
Start date December 3, 2013
Completion date December 30, 2020
View Details
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