Clinical trial NCT05763602: PVI to Prevent S. Aureus SSI After Fixation of HELEF (POTENT Study)
Official title: Intranasal Povidone Iodine (PVI) to Prevent Staphylococcus Aureus Surgical Site Infections After Operative Procedures to Fix High-Energy Lower Extremity Fractures (POTENT Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Surgical Site Infection
Keywords: orthopedic surgery
nasal povidone-iodine
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Indiana University
name: University of Utah
name: Washington University School of Medicine
name: University of Texas
name: Emory University
name: PDI Healthcare
name: Centers for Disease Control and Prevention
First posted: 2023-03-10
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Complex (deep incisional or organ space) Staphylococcus aureus surgical site infection (SSI)
timeFrame: within 180 days of the initial surgical procedure for HELEF repair
Secondary outcomes:
measure: Incidence of all Staphylococcus aureus SSI
timeFrame: within 180 days of the initial surgical procedure for HELEF repair
measure: Incidence of all Complex SSI
timeFrame: within 180 days of the initial surgical procedure for HELEF repair
measure: Incidence of all gram-negative Complex SSI
timeFrame: within 180 days of the initial surgical procedure for HELEF repair
measure: Incidence of cellulitis involving the surgical site
timeFrame: within 180 days of the initial surgical procedure for HELEF repair
measure: Clavien-Dindo assessment of postoperative complications scores
timeFrame: within 180 days of the initial surgical procedure for HELEF repair
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Indianapolis
country: United States
facility: University of Indiana
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Iowa
name: Loreen Herwaldt, MD
role: PRINCIPAL_INVESTIGATOR
References: