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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Surgical Site Infection
• Intervention / Treatment: Drug: povidone-iodine topical ointment

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Emory University
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • University of Indiana
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University
  • Texas
    • Dallas, Texas, United States, 75235
      • University of Texas Southwestern
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nasal Povidone-Iodine Decolonization Intervention; Intranasal povidone-iodine (PDI Profend) will be applied to the patients' noses 60 minutes before surgery to repair HELEF and approximately 12 hours after the first application. If the patient will have additional HELEF repair in the 6 month followup period, intranasal PVI will be applied in a similar manner for each procedure.	Drug: povidone-iodine topical ointment; Intranasal povidone-iodine will be applied to the lower anterior nares (i.e. nostril) of patients undergoing HELEF orthopedic repair.; Other Names: Profend
No Intervention: Concurrent Control; Standard of Care. This will be usual care at each participating site for subjects enrolled in the Baseline period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Complex (deep incisional or organ space) Staphylococcus aureus surgical site infection (SSI)	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	within 180 days of the initial surgical procedure for HELEF repair

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of all Staphylococcus aureus SSI	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	within 180 days of the initial surgical procedure for HELEF repair
Incidence of all Complex SSI	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	within 180 days of the initial surgical procedure for HELEF repair
Incidence of cellulitis involving the surgical site	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.	within 180 days of the initial surgical procedure for HELEF repair
Incidence of all gram-negative Complex SSI	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	within 180 days of the initial surgical procedure for HELEF repair
Clavien-Dindo assessment of postoperative complications scores	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/	within 180 days of the initial surgical procedure for HELEF repair

Collaborators and Investigators

• Sponsor: Loreen Herwaldt
• Collaborators: Washington University School of Medicine; Emory University; Centers for Disease Control and Prevention; University of Texas; University of Utah; Indiana University; PDI Healthcare
• Investigators: Principal Investigator: Loreen Herwaldt, MD, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: February 24, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 10, 2023

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: orthopedic surgery; nasal povidone-iodine
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Infections; Wound Infection; Pathological Conditions, Signs and Symptoms; Surgical Wound Infection; Anti-Infective Agents, Local; Anti-Infective Agents; Plasma Substitutes; Blood Substitutes; Povidone-Iodine; Povidone
• Other Study ID Numbers: 202109074; U54CK000613 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Yes The investigators will submit an electronic version of each peer-reviewed accepted manuscript to PubMed Central to be made publicly available within 12 months of publication. The investigators will respond to requests for restricted public health data sets and ensure responses follow appropriate processes, documentation, and approval.
• IPD Sharing Time Frame: Until year 2026
• IPD Sharing Access Criteria: Upon request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes