Clinical Research Directory
Browse clinical research sites, groups, and studies.
Evaluation of STIMULAN Device and AI Model in Preventing Fracture Infections
Sponsor: Università Vita-Salute San Raffaele
Summary
This is a prospective, single-center, double-blind randomized clinical trial aimed at evaluating the efficacy and safety of the extended-release antibiotic device, STIMULAN, in preventing infections in patients with open fractures. The study will enroll 40 patients from IRCSS San Raffaele's Emergency Department and Orthopedics and Traumatology Unit. Patients will be stratified into high-risk and low-risk infectious subgroups and randomized into either the intervention group receiving the antibiotic device or the control group receiving no device. The follow-up period will last for 5 days, with data collection at specified intervals. Standard laboratory tests will be utilized to monitor the patient's inflammatory response.
Official title: Safety and Efficacy Evaluation of the STIMULAN Device for the Slow Release of Antibiotics in Exposed Fractures in the Prevention of Infections, and Creation of an AI Predictive Model for the Risk of Infections: a Prospective, Monocentric, Randomized, Blind Study
Key Details
Gender
All
Age Range
Any - 65 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2023-11-01
Completion Date
2025-07-01
Last Updated
2024-04-25
Healthy Volunteers
No
Conditions
Interventions
STIMULAN
Procedures: Surgical repair of the open fracture, as per standard-of-care guidelines. Insertion of the STIMULAN device at the site of the fracture. Standard post-operative care, including monitoring of inflammatory markers and clinical signs of infection.
Locations (1)
Ospedale San Raffaele
Milan, Italy