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

NCT05763602 | Active Not Recruiting Phase 4 FDA Drug

• 2 other identifiers: 202109074U54CK000613
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 6

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.

Conditions

Surgical Site Infection

Keywords

orthopedic surgery; nasal povidone-iodine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Incidence of all Staphylococcus aureus SSI

  within 180 days of the initial surgical procedure for HELEF repair

• Incidence of all Complex SSI

  within 180 days of the initial surgical procedure for HELEF repair

• Incidence of all gram-negative Complex SSI

  within 180 days of the initial surgical procedure for HELEF repair

• Incidence of cellulitis involving the surgical site

  within 180 days of the initial surgical procedure for HELEF repair

• Clavien-Dindo assessment of postoperative complications scores

  within 180 days of the initial surgical procedure for HELEF repair

Study Arms (2)

Nasal Povidone-Iodine Decolonization Intervention

EXPERIMENTAL

Intranasal povidone-iodine (PDI Profend) will be applied to the patients' noses 60 minutes before surgery to repair HELEF and approximately 12 hours after the first application. If the patient will have additional HELEF repair in the 6 month followup period, intranasal PVI will be applied in a similar manner for each procedure.

Drug: povidone-iodine topical ointment

Concurrent Control

NO INTERVENTION

Standard of Care. This will be usual care at each participating site for subjects enrolled in the Baseline period.

Interventions

povidone-iodine topical ointment DRUG

Intranasal povidone-iodine will be applied to the lower anterior nares (i.e. nostril) of patients undergoing HELEF orthopedic repair.

Also known as: Profend

Nasal Povidone-Iodine Decolonization Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Loreen Herwaldt: lead
• Indiana University: collaborator
• University of Utah: collaborator
• Washington University School of Medicine: collaborator
• University of Texas: collaborator
• Emory University: collaborator
• PDI Healthcare: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (6)

Emory University

Atlanta, Georgia, 30303, United States

Location

University of Indiana

Indianapolis, Indiana, 46202, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

University of Texas Southwestern

Dallas, Texas, 75235, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Loreen Herwaldt, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 10, 2023
• Study Start: September 15, 2022
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Until year 2026
• Access Criteria: Upon request

Locations

US (6)