Status:
RECRUITING
Evaluation of STIMULAN Device and AI Model in Preventing Fracture Infections
Lead Sponsor:
Università Vita-Salute San Raffaele
Conditions:
Open Fracture
Eligibility:
All Genders
Up to 65 years
Phase:
NA
Brief 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 i...
Detailed Description
This study is a prospective, single-center, randomized clinical trial with a double-blind design for both the patient and the evaluator. The aim is to assess the efficacy and safety of the extended-re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06033534
Start Date
November 1 2023
End Date
July 1 2025
Last Update
April 25 2024
Active Locations (1)
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1
Ospedale San Raffaele
Milan, Italy, 20132