Intramedullary Calcium Sulfate Antibiotic Depot for Prevention of Open Fracture-Related Infection: A Randomized Clinical Trial
Abstract
This research study proposes a randomized clinical trial comparing a standard way to fix bone fractures with and without adding antibiotics to the broken bone as a means to prevent infection. Infections can readily develop after a patient sustains an open fracture or a broken bone that also involves injury to the overlying muscle and skin covering the bone. Despite being given antibiotics by IV and prompt surgical cleaning of open fractures, these injuries remain a difficult source of complications such as infection, which demands more care resources and longer recovery times. This is also true in the military where open fractures of the leg complicated by infection decrease return to duty rates and even lead to amputation. In direct response to FY21 PRORP CTA Focus Areas, this research will seek a simple method added to standard fracture care intended to reduce the burden of fracture related infections. During the course of the study, patients with severe open fractures will be provided standard medical and surgical care including the typical way that fractures are fixed using a rod placed inside the bone. However, these patients will be randomized to either having this standard treatment or the standard treatment plus application of an already clinically available calcium product which is then mixed antibiotics. The calcium sulfate plus antibiotics will be applied inside the bone just prior to placement of the rod to fix the fracture. Patients in the study will be monitored for 1 year. By this time, most leg fractures are healed unless a complication such as infection interrupts the healing progress. Therefore, the expected timeline to understand whether the bone-antibiotic application is helpful to prevent infection is well within the time frame of the study. A tremendous benefit of the study is that the calcium sulfate product that will be used to deliver antibiotic to bone is already clinically available and commonly used in orthopaedic surgery. Additionally, the antibiotics are already available. This simple, but novel, use of these products together to prevent bone infection is the type of solution that can be rapidly deployed where ever fracture care is performed. Results of this study are expected to help patients, both military and civilian, who unfortunately experience open fracture injuries. Any means to reduce the chance of an infection developing after an open fracture will be of benefit because the patient avoids additional medical and surgical treatment for the infection, avoids additional treatment because the infection may cause the bone to not heal and allows the patient to resume normal work and life activities at a time line uninterrupted by infection. For the military, preventing infection after severe leg injuries will support quicker return to duty with similar avoidance of the extra care for the infection complication.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 28, 2022
- Source ID
- W81XWH2210937
Entities
People
- Jessica C. Rivera
Organizations
- LSU Health Sciences Center New Orleans
- United States Army