Using an antibiotic device to prevent infections in open fractures
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
This study is testing whether an antibiotic device can help prevent infections in patients with open fractures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | N/A to 65 Years |
| Sex | All |
| Sponsor | Università Vita-Salute San Raffaele Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06033534 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of the STIMULAN device, an extended-release antibiotic, in preventing infections in patients with open fractures. It is a prospective, single-center, double-blind randomized trial involving 40 patients from the Emergency Department and Orthopedics and Traumatology Unit at IRCSS San Raffaele. Patients will be stratified into high-risk and low-risk infectious subgroups and randomized to receive either the antibiotic device or no device. The follow-up period lasts for 5 days, during which standard laboratory tests will monitor the inflammatory response.
Who should consider this trial
Good fit: Ideal candidates include patients with open fractures requiring surgical intervention, classified as Gustilo-Anderson Type I, II, IIIa, IIIb, or IIIc.
Not a fit: Patients with active infections or severe renal or hepatic insufficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of infections in patients with open fractures.
How similar studies have performed: Other studies have shown promise in using antibiotic devices for infection prevention, making this approach a potentially valuable addition to current practices.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Milan
- Ospedale San Raffaele — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Giacomo Placella, MD
- Email: giacomo.placella@hsr.it
- Phone: 3927123432
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.