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Evaluation of STIMULAN Device and AI Model in Preventing Fracture Infections

Primary Purpose

Open Fracture

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
STIMULAN
Sponsored by
Università Vita-Salute San Raffaele
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Open Fracture

Eligibility Criteria

undefined - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ospedale San RaffaeleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

STIMULAN DEVICE USED

STIMULAN DEVICE NOT USED

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 4, 2023
Last Updated
September 26, 2023
Sponsor
Università Vita-Salute San Raffaele
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1. Study Identification

Unique Protocol Identification Number
NCT06033534
Brief Title
Evaluation of STIMULAN Device and AI Model in Preventing Fracture Infections
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università Vita-Salute San Raffaele

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Fracture

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
STIMULAN DEVICE USED
Arm Type
Experimental
Arm Description
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.
Arm Title
STIMULAN DEVICE NOT USED
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
STIMULAN
Intervention Description
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.
Primary Outcome Measure Information:
Title
Infected Open Fracture
Description
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.
Time Frame
5 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giacomo Placella, MD
Phone
3927123432
Ext
+39
Email
giacomo.placella@hsr.it
Facility Information:
Facility Name
Ospedale San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolo Biavardi
Phone
+393663408250
Email
n.biavardi@studenti.unisr.it

12. IPD Sharing Statement

Learn more about this trial

Evaluation of STIMULAN Device and AI Model in Preventing Fracture Infections

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