Evaluation of STIMULAN Device and AI Model in Preventing Fracture Infections
Open Fracture
About this trial
This is an interventional prevention trial for Open Fracture
Eligibility Criteria
Inclusion Criteria: Open fractures of any type and location Fractures classified as Gustilo-Anderson Type I, II, IIIa, IIIb, IIIc Patients requiring surgical intervention for fracture correction Patients with no contraindications for antibiotic treatment Patients providing informed consent Exclusion Criteria: Patients with active infections Patients with a history of allergies or adverse reactions to the antibiotics used in the extended-release device Patients with severe renal or hepatic insufficiency Non-cooperative patients or those who are unable to adhere to follow-up visits or study procedures due to physical or mental limitations or severe neurological illness Patients who have undergone spinal surgery
Sites / Locations
- Ospedale San RaffaeleRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
STIMULAN DEVICE USED
STIMULAN DEVICE NOT USED
Patients allocated to this arm will receive an extended-release antibiotic device, STIMULAN, as a prophylactic measure against bacterial infection post-fracture repair surgery. The device is designed to release antibiotics in a controlled manner over a specified period of time.
Patients in this arm will undergo the surgical repair of their open fracture but will not receive any antibiotic device for prophylaxis against bacterial infections.