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

Loreen Herwaldt

Status and phase: Active, not recruiting; Phase 4

Conditions: Surgical Site Infection

Treatments: Drug: povidone-iodine topical ointment

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05763602

U54CK000613 (U.S. NIH Grant/Contract)

202109074

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,000 participants in 2 patient groups

Nasal Povidone-Iodine Decolonization Intervention

Experimental group

Description:

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.

Treatment:

Drug: povidone-iodine topical ointment

Concurrent Control

No Intervention group

Description:

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