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

Description

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.

Conditions

Surgical Site Infection

Talk to us

Study Overview

On this page

Study Details

Study 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.

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

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

Condition
Surgical Site Infection
Intervention / Treatment

-

Contacts and Locations

Atlanta

Emory University, Atlanta, Georgia, United States, 30303

Indianapolis

University of Indiana, Indianapolis, Indiana, United States, 46202

Iowa City

University of Iowa, Iowa City, Iowa, United States, 52242

Saint Louis

Washington University, Saint Louis, Missouri, United States, 63110

Dallas

University of Texas Southwestern, Dallas, Texas, United States, 75235

Salt Lake City

University of Utah, Salt Lake City, Utah, United States, 84108

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Loreen Herwaldt,

Loreen Herwaldt, MD, PRINCIPAL_INVESTIGATOR, University of Iowa

Study Record Dates

2026-02-15