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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
2,000
Intranasal povidone-iodine will be applied to the lower anterior nares (i.e. nostril) of patients undergoing HELEF orthopedic repair.
Emory University
Atlanta, Georgia, United States
University of Indiana
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
Washington University
St Louis, Missouri, United States
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
Time frame: within 180 days of the initial surgical procedure for HELEF repair
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: within 180 days of the initial surgical procedure for HELEF repair
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University of Texas Southwestern
Dallas, Texas, United States
University of Utah
Salt Lake City, Utah, United States
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/
Time frame: within 180 days of the initial surgical procedure for HELEF repair