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Evaluation of STIMULAN Device and AI Model in Preventing Fracture Infections

NCT06033534 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-04-25

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Università Vita-Salute San Raffaele

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2024-07-01
Completion
2025-07-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06033534 on ClinicalTrials.gov