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

Surgical Site Infection Clinical Trial

— POTENT  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05763602
• Other study ID #: 202109074
• Secondary ID: U54CK000613
• Status: Recruiting
• Phase: Phase 4
• Start date: September 15, 2022
• Est. completion date: May 31, 2025

Study information

• Verified date: March 2023
• Source: University of Iowa
• Contact: Loreen Herwaldt, MD
• Phone: +1 319 356 0474
• Email: loreen-herwaldt[@]uiowa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: May 31, 2025
• Est. primary completion date: February 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 cannot consent, including patients with dementia, delirium, coma, impaired mental status, traumatic brain injury, and patients who are sedated or intubated.
• Closed, isolated rotational ankle fractures
• Patients who do not speak English or Spanish

Related Conditions & MeSH terms

• Infections
• Surgical Site Infection
• Surgical Wound Infection

Intervention

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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University of Texas Southwestern	Dallas	Texas
United States	University of Indiana	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	Washington University	Saint Louis	Missouri
United States	University of Utah	Salt Lake City	Utah

Sponsors (8)

Lead Sponsor	Collaborator
Loreen Herwaldt	Centers for Disease Control and Prevention, Emory University, Indiana University, PDI Healthcare, University of Texas, University of Utah, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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