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NCT Number: NCT05763602

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Emory University, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

povidone-iodine topical ointment

Drug

Intranasal povidone-iodine will be applied to the lower anterior nares (i.e. nostril) of patients undergoing HELEF orthopedic repair.

Other names: Profend

Primary outcomes

  1. Incidence of Complex (deep incisional or organ space) Staphylococcus aureus surgical site infection (SSI)

    Time frame: within 180 days of the initial surgical procedure for HELEF repair

    Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) definitions for SSI found in the "Surgical Site Infection Event (SSI)" guide at https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf

Secondary outcomes

  1. Incidence of all Staphylococcus aureus SSI

    Time frame: within 180 days of the initial surgical procedure for HELEF repair

    Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) definitions for SSI found in the "Surgical Site Infection Event (SSI)" guide at https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf

  2. Incidence of all Complex SSI

    Time frame: within 180 days of the initial surgical procedure for HELEF repair

    Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) definitions for SSI found in the "Surgical Site Infection Event (SSI)" guide at https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf

  3. Incidence of all gram-negative Complex SSI

    Time frame: within 180 days of the initial surgical procedure for HELEF repair

    Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) definitions for SSI found in the "Surgical Site Infection Event (SSI)" guide at https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf

  4. Incidence of cellulitis involving the surgical site

    Time frame: within 180 days of the initial surgical procedure for HELEF repair

    Cellulitis is a common bacterial skin infection that causes redness, swelling, and pain in the infected area of the skin surrounding the surgical site of the HELEF repair.

  5. Clavien-Dindo assessment of postoperative complications scores

    Time frame: within 180 days of the initial surgical procedure for HELEF repair

    The Clavien-Dindo assessment grades postoperative surgical complications from 1 to 5, with 5 being the worst outcome. Postoperative courses with no evidence of complications have no grade (a "0" for the purposes of this study). Clavien-Dindo assessment definitions found at: https://www.assessurgery.com/clavien-dindo-classification/

Sponsors and collaborators

Lead sponsor

Loreen Herwaldt

Other

Collaborators

  • Centers for Disease Control and Prevention
  • Emory University
  • Indiana University
  • PDI Healthcare
  • University of Texas
  • University of Utah
  • Washington University School of Medicine

Registry information

Official study title

Intranasal Povidone Iodine (PVI) to Prevent Staphylococcus Aureus Surgical Site Infections After Operative Procedures to Fix High-Energy Lower Extremity Fractures (POTENT Study)

Acronym: POTENT

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2023
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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