Intranasal Povidone Iodine (PVI) to Prevent Staphylococcus aureus

Investigating Nasal Application of Povidone Iodine to Prevent Infections in Surgeries Related to Bones and Muscles

T
Todd McKinley, MD

Primary Investigator

Enrolling By Invitation
18 years - 100 years
All
Phase 4
20 participants needed
1 Location

Brief description of 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.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY

Detailed description of study

Researchers will collect health history information from participants' medical records before and after surgery. Some participants will be asked to put iodine inside their noses before and after surgery. 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 of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Bone fracture, Leg fracture, Ankle fracture, tibia fracture, femure fracture, Surgical Site Infection
  • Age: 18 years - 100 years
  • Gender: All

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.
 

This study investigates whether applying povidone iodine (PVI) to the noses of patients undergoing leg, ankle, or foot surgeries can reduce the risk of infections at surgical sites, especially those caused by the bacteria Staphylococcus aureus. Patients with high-energy lower extremity fractures (HELEF) are at a higher risk for these infections. Staphylococcus aureus is a type of bacteria that can cause infections in different parts of the body, and surgical site infections (SSI) are infections that occur after surgery in the part of the body where the surgery took place.

Participants in the study will have their health history collected from medical records before and after surgery. Some participants will apply iodine inside their noses before and after surgery. The iodine will be applied within 60 minutes before the surgery and again about 12 hours after the first dose. Researchers will collect information from medical records about the participants' health, injuries, surgeries, and any infections for six months after their operations. They will also follow up with participants at a six-month visit to check for any treatment for infections outside the study system.

  • Who can participate: Adults over 18 undergoing surgeries for high-energy lower extremity fractures, like open tibia or femur fractures, are eligible. Participants must not have iodine allergies, be pregnant, or have active infections at the fracture site.
  • Study details: Participants will have health data collected from medical records and may apply an iodine solution to their noses before and after surgery. This study does not alter the surgical treatment participants receive.
  • Study timelines: The study will last 6 months.
Updated on 06 Mar 2026. Study ID: ORTHO-UI-POTENT, 14394
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only