Image

PVI to Prevent S. Aureus SSI After Fixation of HELEF (POTENT Study)

PVI to Prevent S. Aureus SSI After Fixation of HELEF (POTENT Study)

Recruiting
18 years and older
All
Phase 4

Powered by AI

Overview

The purpose of this study is to see whether applying povidone iodine (PVI) to the noses of patients undergoing lower extremity (leg, ankle, or foot) orthopedic fixation procedures of high-energy lower extremity fractures (HELEF) will decrease the patients' risk of surgical site infections (SSI), particularly those caused by Staphylococcus aureus.

Description

These patients are at high risk of SSI but given the rapidity with which they need their operations, interventions that take time are difficult or impossible to use in this patient population. This study will involve identifying patients with HELEF and applying PVI to their nares within 60 minutes before their surgical incisions are made and again approximately 12 hours after the first dose. The investigators will abstract information from the patients' medical records about their demographics, underlying illnesses, injury severity, the surgical procedures, and SSI for the 6 months following their operations and the investigators will see them during their routinely scheduled visit at about 6 months to ask them whether they were treated for SSI by providers outside of our system. For patients who do not return for follow up, the investigators will try to contact them to determine if they had signs or symptoms of SSI or were treated for SSI outside of our system.

Eligibility

Inclusion Criteria:

  • Age > 18 years of age.
  • Is undergoing one or more procedures to address the included fractures listed below for one or more (at least one) HELEF at high-risk for SSI:
    • Open tibia fractures
    • Open femur fractures
    • Open or closed tibial plateau fractures
    • Open or closed tibial pilon fractures
    • Open or closed calcaneus fractures
    • Open or closed talus fractures
    • Open or closed foot fractures of any bone EXCEPT the toes
    • Open fibula fractures
    • Open rotational ankle fractures (malleoli)
    • Open or closed leg fractures associated with compartment syndrome
  • Examples of included procedures:
    • Excisional debridement of open fracture, femur and/or tibia
    • Intramedullary nail, tibia (open injury)
    • Intramedullary nail, femur (open injury)
    • Open reduction Pilon/Plafond fracture
    • Open reduction tibial plateau fracture
    • Open reduction calcaneal fracture
    • Open reduction Lisfranc/metatarsal associated with crush injury
    • Open reduction talus
    • External fixation, lower extremity tibia or femur associated with open fracture or compartment syndrome
    • Fasciotomy, lower extremity for compartment syndrome related to femur, tibia, or foot fracture
    • Lower extremity amputation related to HELEF

Exclusion Criteria:

  • Documented or verbalized sensitivity or allergy to iodine or iodine-based contrast.
  • Known pregnancy in women.
  • Active bacterial infection at the HELEF site.
  • Incarcerated persons.
  • Persons who cannot follow up at the participating site (e.g., people who are homeless at the time of the injury or people with intellectual challenges who lack the social support for follow up visits).
  • Patients with facial fractures or other conditions that preclude nasal swabbing.
  • Patients who do not speak English or Spanish.

Study details
    Surgical Site Infection

NCT05763602

Loreen Herwaldt

26 May 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.