Evaluation of STIMULAN Device and AI Model in Preventing Fracture Infections

Open Fracture Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06033534
• Other study ID #: ATinFE
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: July 1, 2025

Study information

• Verified date: April 2024
• Source: Università Vita-Salute San Raffaele
• Contact: Giacomo Placella, MD
• Phone: 3927123432
• Email: giacomo.placella[@]hsr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Open
• Open Fracture

Intervention

Device:
• 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

Country	Name	City	State
Italy	Ospedale San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Università Vita-Salute San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infected Open Fracture	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.	5 days