Powdered Intrawound Vancomycin in Open Fractures Trial

Launched by UNIVERSITY OF MANITOBA · Jul 10, 2024

Keywords

ClinConnect Summary

The Powdered Intrawound Vancomycin in Open Fractures Trial is a study aimed at understanding whether adding a special antibiotic powder called vancomycin to the treatment of open fractures can help reduce the risk of infections after surgery. Open fractures are serious injuries where the broken bone breaks through the skin, and infection is a common concern. In this trial, patients with certain types of open fractures in their arms or legs will be randomly assigned to receive either the antibiotic powder along with standard intravenous antibiotics or just the standard treatment alone.

To be eligible for this study, participants need to be 18 years or older and have a specific type of open fracture that requires surgical treatment with hardware like plates or screws. They also need to be able to attend follow-up appointments for six months after their surgery. It’s important to note that individuals with allergies to vancomycin, those who already have an infection at the time of enrollment, or those with certain other medical conditions may not be able to participate. This trial is currently not yet recruiting participants, but it represents an opportunity to contribute to research that could improve care for patients with open fractures.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18 years or older at time of surgery
• • Patients with an open fracture classified as Gustilo Type I to IIIc in the clavicle, humerus, radius, ulna, metacarpals, upper extremity phalanges (fingers), femur, tibia, fibula and metatarsals and lower extremity phalanges (toes).
• • Open fracture treated operatively with plate(s) and screw(s) hardware fixation and intramedullary fixation (IM nail).
• • Able to attend standard of care follow up for six months post-operatively
• Exclusion Criteria:
• • Patients with known vancomycin allergy, drug administration reaction, or other sensitivities to vancomycin.
• • Patients who have already had definitive fracture fixation before enrollment in the study
• • Patients with open fracture already infected at time of enrollment
• • Patients with current positive blood cultures (bacteremia) at time of enrollment (current, meaning they have not received treatment and now have negative most-recent blood cultures).
• • Patients who have other forms of local antibiotics that are left in place at the end of the definitive fixation surgery (e.g., antibiotic loaded cement or polymethyl methacrylate (PMMA) beads)
• • Patients who do not speak English
• • Patients who are currently pregnant
• • Patients who are unable to provide consent and do not have a substitute decision maker able to provide consent
• • Patients who will have severe difficulty with follow up