Calcium Sulfate Antibiotic Depot for Open Tibia Fractures
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment to prevent infections in people with open fractures of the lower leg. Researchers compare a special calcium sulfate antibiotic mix (Intramedullary Calcium Sulfate Antibiotic Depot) with usual care to determine its effectiveness in stopping infections. Individuals with a type II or III open tibia fracture requiring intramedullary nail fixation may qualify for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that a special treatment using calcium sulfate with antibiotics, designed for open leg bone fractures, looks promising in fighting infections. This treatment delivers antibiotics directly into the bone, helping to kill bacteria and stop them from growing. This is important for healing fractures without complications.
In animal studies, these calcium sulfate antibiotics effectively cleared infections and reduced the formation of biofilms, protective layers that bacteria create to shield themselves from antibiotics. This suggests the treatment might work well in humans too.
Additionally, research has shown high success rates in patients treated with this type of antibiotic along with standard antibiotics. Most patients experienced healing of their fractures, and infections were kept under control.
While the treatment looks promising, it's important to know that researchers are still testing it for safety and effectiveness in humans. The current trial phase suggests some evidence of safety, but more information is being gathered to confirm this. Always consult with a healthcare provider to discuss potential risks and benefits.12345Why do researchers think this study treatment might be promising?
Researchers are excited about the intramedullary calcium sulfate antibiotic depot because it offers a novel approach to treating open tibia fractures. This treatment combines calcium sulfate with antibiotics like vancomycin and tobramycin, allowing for localized drug delivery directly to the fracture site. Unlike standard treatments that rely solely on surgical hardware like intramedullary nails, this depot can potentially reduce infection rates by delivering antibiotics precisely where they are needed. This targeted delivery could lead to faster healing and fewer complications, making it a promising alternative to current care options.
What evidence suggests that the intramedullary calcium sulfate antibiotic depot is effective for preventing infection in open tibia fractures?
Research shows that using a calcium sulfate antibiotic depot inside the bone may help prevent infections in open leg fractures. In this trial, one group of participants will receive the intramedullary calcium sulfate antibiotic depot before intramedullary nailing. Studies have found that calcium sulfate with antibiotics can treat infections, suggesting it might also prevent them. In a study of patients with fractures that weren't healing, 93.3% experienced bone healing after receiving a similar calcium sulfate treatment. This indicates that the treatment might not only prevent infections but also aid in bone healing. Overall, these findings suggest that placing an antibiotic depot in the bone could help prevent infections in open leg fractures.14678
Who Is on the Research Team?
Rachel Seymour, PhD
Principal Investigator
Wake Forest University Health Sciences
Jessica Rivera, MD
Principal Investigator
Louisiana State University Health Science Center
Are You a Good Fit for This Trial?
Adults over 18 with a Type II or III open tibia fracture needing an intramedullary nail can join. Excluded are those under 18, allergic to vancomycin/tobramycin, with high blood calcium levels, without contact info, prisoners, non-English/Spanish speakers, and pregnant or breastfeeding women.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either a calcium sulfate antibiotic depot or standard intramedullary nailing during definitive fixation of open tibia fractures
Follow-up
Participants are monitored for safety and effectiveness after treatment, with data capture at multiple time points
What Are the Treatments Tested in This Trial?
Interventions
- Intramedullary Calcium Sulfate Antibiotic Depot
Intramedullary Calcium Sulfate Antibiotic Depot is already approved in European Union, United States, Canada for the following indications:
- Bone and soft tissue infections
- Osteomyelitis
- Musculoskeletal defects created by surgery, cyst, tumor, osteomyelitis or traumatic injury
- Bone voids or defects of the skeletal system created by surgery, cyst, tumor, osteomyelitis or traumatic injury
- Bacterial infection in surrounding soft tissue
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor