Back to resultsPVI to Prevent S. Aureus SSI After Fixation of HELEF (POTENT Study) (POTENT)
Primary Purpose
Surgical Site Infection
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
povidone-iodine topical ointment
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Site Infection focused on measuring orthopedic surgery, nasal povidone-iodine
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 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
Sites / Locations
- Emory University
- University of IndianaRecruiting
- University of IowaRecruiting
- Washington UniversityRecruiting
- University of Texas Southwestern
- University of UtahRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Nasal Povidone-Iodine Decolonization Intervention
Concurrent Control
Arm 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.
Standard of Care. This will be usual care at each participating site for subjects enrolled in the Baseline period.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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.
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/
Full Information
NCT ID
NCT05763602
First Posted
February 24, 2023
Last Updated
March 9, 2023
Sponsor
Loreen Herwaldt
Collaborators
Indiana University, University of Utah, Washington University School of Medicine, University of Texas, Emory University, PDI Healthcare, Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT05763602
Brief Title
PVI to Prevent S. Aureus SSI After Fixation of HELEF (POTENT Study)
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
February 15, 2025 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Loreen Herwaldt
Collaborators
Indiana University, University of Utah, Washington University School of Medicine, University of Texas, Emory University, PDI Healthcare, Centers for Disease Control and Prevention
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
Keywords
orthopedic surgery, nasal povidone-iodine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nasal Povidone-Iodine Decolonization Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Concurrent Control
Arm Type
No Intervention
Arm Description
Standard of Care. This will be usual care at each participating site for subjects enrolled in the Baseline period.
Intervention Type
Drug
Intervention Name(s)
povidone-iodine topical ointment
Other Intervention Name(s)
Profend
Intervention Description
Intranasal povidone-iodine will be applied to the lower anterior nares (i.e. nostril) of patients undergoing HELEF orthopedic repair.
Primary Outcome Measure Information:
Title
Incidence of Complex (deep incisional or organ space) Staphylococcus aureus surgical site infection (SSI)
Description
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
Time Frame
within 180 days of the initial surgical procedure for HELEF repair
Secondary Outcome Measure Information:
Title
Incidence of all Staphylococcus aureus SSI
Description
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
Time Frame
within 180 days of the initial surgical procedure for HELEF repair
Title
Incidence of all Complex SSI
Description
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
Time Frame
within 180 days of the initial surgical procedure for HELEF repair
Title
Incidence of all gram-negative Complex SSI
Description
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
Time Frame
within 180 days of the initial surgical procedure for HELEF repair
Title
Incidence of cellulitis involving the surgical site
Description
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.
Time Frame
within 180 days of the initial surgical procedure for HELEF repair
Title
Clavien-Dindo assessment of postoperative complications scores
Description
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/
Time Frame
within 180 days of the initial surgical procedure for HELEF repair
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Loreen Herwaldt, MD
Phone
+1 319 356 0474
Email
loreen-herwaldt@uiowa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa A Ward, MS
Phone
+1 319 384 8284
Email
melissa-ward@uiowa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loreen Herwaldt, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mara Schenker
Email
mara.schenker@emory.edu
First Name & Middle Initial & Last Name & Degree
Roberto C Hernandez Irizarry
Email
roberto.c.hernandez@emory.edu
Facility Name
University of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Todd McKinley
Email
tmckinley@IUHealth.org
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Loreen Herwaldt
Phone
319-356-8150
Email
loreen-herwaldt@uiowa.edu
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Miller
Email
milleran@wustl.edu
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Staff, MD
Email
adam.starr@utsouthwestern.edu
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Haller
Email
justin.haller@hsc.utah.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Yes The investigators will submit an electronic version of each peer-reviewed accepted manuscript to PubMed Central to be made publicly available within 12 months of publication. The investigators will respond to requests for restricted public health data sets and ensure responses follow appropriate processes, documentation, and approval.
IPD Sharing Time Frame
Until year 2026
IPD Sharing Access Criteria
Upon request
Learn more about this trial
PVI to Prevent S. Aureus SSI After Fixation of HELEF (POTENT Study)
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