ACTIVE_NOT_RECRUITING

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

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Conditions

Surgical Site Infectionorthopedic surgerynasal povidone-iodine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2022-09-15
Study Completion:2026-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05763602

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \> 18 years of age.
  2. * 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:
  3. * Open tibia fractures
  4. * Open femur fractures
  5. * Open or closed tibial plateau fractures
  6. * Open or closed tibial pilon fractures
  7. * Open or closed calcaneus fractures
  8. * Open or closed talus fractures
  9. * Open or closed foot fractures of any bone EXCEPT the toes
  10. * Open fibula fractures
  11. * Open rotational ankle fractures (malleoli)
  12. * Open or closed leg fractures associated with compartment syndrome
  13. * Examples of included procedures:
  14. * Excisional debridement of open fracture, femur and/or tibia
  15. * Intramedullary nail, tibia (open injury)
  16. * Intramedullary nail, femur (open injury)
  17. * Open reduction Pilon/Plafond fracture
  18. * Open reduction tibial plateau fracture
  19. * Open reduction calcaneal fracture
  20. * Open reduction Lisfranc/metatarsal associated with crush injury
  21. * Open reduction talus
  22. * External fixation, lower extremity tibia or femur associated with open fracture or compartment syndrome
  23. * Fasciotomy, lower extremity for compartment syndrome related to femur, tibia, or foot fracture
  24. * Lower extremity amputation related to HELEF
  1. * Documented or verbalized sensitivity or allergy to iodine or iodine-based contrast.
  2. * Known pregnancy in women.
  3. * Active bacterial infection at the HELEF site.
  4. * Incarcerated persons.
  5. * 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).
  6. * Patients with facial fractures or other conditions that preclude nasal swabbing.
  7. * Patients who do not speak English or Spanish.

Contacts and Locations

Principal Investigator

Loreen Herwaldt, MD
PRINCIPAL_INVESTIGATOR
University of Iowa

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Loreen Herwaldt

  • Loreen Herwaldt, MD, PRINCIPAL_INVESTIGATOR, University of Iowa

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-15
Study Completion Date2026-05-31

Study Record Updates

Study Start Date2022-09-15
Study Completion Date2026-05-31

Terms related to this study

Keywords Provided by Researchers

  • orthopedic surgery
  • nasal povidone-iodine

Additional Relevant MeSH Terms

  • Surgical Site Infection