Evaluation of STIMULAN Device and AI Model in Preventing Fracture Infections

NCT06033534 | Recruiting

• 1 other identifier: ATinFE
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Open Fracture

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

STIMULAN DEVICE USED

EXPERIMENTAL

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.

Device: STIMULAN

STIMULAN DEVICE NOT USED

NO INTERVENTION

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.

Interventions

STIMULAN DEVICE

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.

STIMULAN DEVICE USED

Eligibility Criteria

• Age: Up to 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Università Vita-Salute San Raffaele: lead

Study Sites (1)

Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Fractures, Open

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Central Study Contacts

Giacomo Placella, MD

CONTACT

3927123432; giacomo.placella@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 13, 2023
• Study Start: November 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2025
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

IT (1)