Treatment of Early Post-op Wound Infection after Internal Fixation
Abstract
Postoperative infection is one of the most prevalent and challenging complications faced by orthopaedic surgeons and patients in both the military and civilian populations. The wounds are contaminated or colonized at the time of injury, during the course of therapy, or both. Infection is always a possibility with any surgical intervention, particularly in the setting of orthopaedic trauma where multiple factors make the prevention and treatment of these infections very complicated. As a result of slow enrollment at the five pilot sites, investigators consulted with several Infectious Disease specialists and discussed ways to expand the study population. The expansion will include all fractures or fusions involving long bone after internal fixation or joint fusion. The primary goal is to delineate optimal or equivalency or the antibiotic drug delivery method of IV vs PO. The study team felt that these changes needed to be made in order to move the study forward. As a result of the study population changes, we have changed the primary study outcome from a binary outcome (treatment failure) to a continuous outcome (number of surgeries) in order to maximize statistical power. During the protocol modification and review period, the five pilot sites continued to recruit and enroll patients and the data collection forms were modified and reviewed by the protocol committee. The changes are being finalized and the study materials distributed to the rest of the participating centers for training and implementation by the end of this calendar year.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2013
- Accession Number
- ADA594151
Entities
People
- William Obremskey
Organizations
- Vanderbilt University Medical Center