- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06033534
Evaluation of STIMULAN Device and AI Model in Preventing Fracture Infections
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
Study Overview
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-release antibiotic device STIMULAN in preventing infections in patients with open fractures.
The trial will be a randomized study that will enroll two cohorts of patients with open fractures, sourced from both the Emergency Department of IRCSS San Raffaele and the Orthopedics and Traumatology Unit. Fractures will be classified according to the Gustilo Classification. Patients requiring surgical repair of the exposed fracture will be randomized to receive either the extended-release antibiotic device or no device at all. The randomization of this study is stratified, with a 1:1 ratio, and 40 patients will be divided into two groups:
Intervention group: extended-release antibiotic device Control group: no device
Two stratification subgroups will be included:
High-risk infectious subgroup Low-risk infectious subgroup For the definition of stratification, please refer to Section 9.1, Risk Assessment Table for Stratification.
Patients will be followed for a duration of 5 days, and follow-up data will be collected at established intervals. According to recent studies, the onset of initial infections occurs between 24 and 72 hours following the episode of open fracture. Therefore, a 5-day period is deemed a reasonable time frame for constant monitoring. Standard-of-care laboratory tests such as white blood cell count, C-reactive protein, erythrocyte sedimentation rate, and procalcitonin will also be collected and analyzed to determine the patient's inflammatory response.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Giacomo Placella, MD
- Phone Number: +39 3927123432
- Email: giacomo.placella@hsr.it
Study Locations
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Milan, Italy, 20132
- Recruiting
- Ospedale San Raffaele
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Contact:
- Nicolo Biavardi
- Phone Number: +393663408250
- Email: n.biavardi@studenti.unisr.it
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: STIMULAN DEVICE 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.
|
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. |
No Intervention: STIMULAN DEVICE NOT USED
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Infected Open Fracture
Time Frame: 5 days
|
The primary outcome measure of this clinical trial is the incidence of bacterial infections following surgical intervention for open fractures in both the intervention and control arms.
This will be quantified as the number of confirmed bacterial infections per total number of participants in each arm, expressed as a percentage.
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5 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ATinFE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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