POvIV Study

POvIV Study


A Prospective Randomized Trial to Assess PO versus IV Antibiotics for the Treatment of Post-op Wound Infection after Extremity Fractures
(POvIV Study)


Principal Investigator: Dr. William Obremskey

The goal of this study is to investigate the efficacy of oral (par oris - PO) antibiotic therapy versus intravenous (IV) systemic antibiotics in the treatment of acute infection after plate fixation of fractures.


Postoperative infection is one of the most prevalent and challenging complications faced by orthopaedic surgeons and patients in the military and civilian populations. Irrigation and debridement coupled with a prolonged course of antibiotics is the standard of care for post-operative wound infections. Current treatment regimens practiced throughout North America and Europe require patients with post operative infections to receive up to six weeks of intravenous antibiotic therapy following surgical debridement. However, prolonged intravenous therapy is associated with a substantial risk of line sepsis, tip occlusion and vein thrombosis. In addition, parenteral antibiotic therapy is expensive and is not possible for all patients because of the cost or lack of resources. The cost to treat infection after fracture fixation is significant and a large proportion of these costs are associated with intravenous antibiotic therapy. Since the cost of outpatient intravenous antibiotic therapy is significantly more expensive than oral antibiotic agents, it is important to investigate oral antibiotics as a potential therapy for the treatment of infection after internal fixation of fractures.


The POvIV study will compare the efficacy of PO versus IV antibiotics in patients that develop a culture positive, post-operative deep infection after operative irrigation and debridement. We will assess differences in rates of re-hospitalization, infection, non-union, and amputation. Also to be assessed are the rates of compliance and medical costs associated with each treatment. We hypothesize that the rate of treatment failure, re-hospitalization for complication, infection, non-union, and amputation and compliance will be similar across groups, but per patient total medical costs at 1 year will be lower in the PO antibiotic group compared to the IV antibiotic group.


Approximately 264 patients who meet the inclusion and exclusion criteria and agree to participate in the study will be randomly assigned to one of two treatment groups: operative debridement and PO antibiotic suppression or operative debridement and IV antibiotics. Both groups will receive standard care, including debridement and soft tissue coverage of wounds; laboratory evaluation of inflammatory markers at 2 weeks, and 6 weeks; clinical follow at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months to assess recurrence of wound infection; and radiographic follow up at 6 weeks and 3 months or until boney union is confirmed.


This study is being funded by a DOD CDMRP Individual Clinical Trial Grant (W81XWH-10-2-0133) awarded to Vanderbilt University.