Evaluation of STIMULAN Device and AI Model in Preventing Fracture Infections

NCT ID: NCT06033534

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2025-07-01

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.

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.

Conditions

Open Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

STIMULAN

Intervention Type: 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 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Università Vita-Salute San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Professor Giacomo Placella

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ospedale San Raffaele

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Giacomo Placella, MD

Role: CONTACT

giacomo.placella@hsr.it

3927123432 ext. +39

Facility Contacts

Nicolo Biavardi

Role: primary

n.biavardi@studenti.unisr.it

+393663408250

Other Identifiers

ATinFE

Identifier Type: -

Identifier Source: org_study_id