Surgical Site InfectionPhase 4POTENTNCT05763602
PVI to Prevent S. Aureus SSI After Fixation of HELEF (POTENT Study)
A Phase 4 study testing povidone-iodine topical ointment in people with Surgical Site Infection, run by Loreen Herwaldt at 6 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- povidone-iodine topical ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 6 sitesUnited States
- Study dates
- 15 Sep 2022to 31 May 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 24Show fewer
- 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
Who cannot join
- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Emory University
Atlanta, Georgia, 30303
University of Texas Southwestern
Dallas, Texas, 75235
University of Indiana
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52242
University of Utah
Salt Lake City, Utah, 84108
Washington University
St Louis, Missouri, 63110
About this study
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)
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.
Read the 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.
- Conditions
- Surgical Site Infection
- Being tested
- povidone-iodine topical ointment
- Keywords
- orthopedic surgery, nasal povidone-iodine
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
povidone-iodine topical ointmentDrug
Also called Profend
Intranasal povidone-iodine will be applied to the lower anterior nares (i.e. nostril) of patients undergoing HELEF orthopedic repair.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 180 days of the initial surgical procedure for HELEF repair
Secondary outcomes (5)
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
Measured: within 180 days of the initial surgical procedure for HELEF repair
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
Measured: within 180 days of the initial surgical procedure for HELEF repair
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
Measured: within 180 days of the initial surgical procedure for HELEF repair
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.
Measured: within 180 days of the initial surgical procedure for 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/
Measured: within 180 days of the initial surgical procedure for HELEF repair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start15 Sep 2022
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loreen Herwaldt
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University, University of Utah, Washington University School of Medicine, University of Texas, Emory University, PDI Healthcare, Centers for Disease Control and Prevention
- Responsible party
- Sponsor-investigator, Loreen Herwaldt, University of Iowa
- Investigators
- Loreen Herwaldt, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763602
- Sponsor's protocol ID
- 202109074
- Other IDs
- U54CK000613
- Acronym
- POTENT
- Status last verified
- Feb 2026
- First submitted
- 24 Feb 2023
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05763602
- Acronym / sponsor ID
- POTENT / 202109074
- Conditions
- Surgical Site Infection
- Keywords
- orthopedic surgery, nasal povidone-iodine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Loreen HerwaldtUniversity, hospital or other
- Collaborators
- Indiana University, University of Utah, Washington University School of Medicine, University of Texas, Emory University, PDI Healthcare, Centers for Disease Control and Prevention
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal Povidone-Iodine Decolonization Intervention | Experimental | Drug: povidone-iodine topical ointmentIntranasal 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. |
| Concurrent Control | No intervention | –Standard of Care. This will be usual care at each participating site for subjects enrolled in the Baseline period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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:
- Examples of included procedures:
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| povidone-iodine topical ointmentAlso: ProfendIntranasal povidone-iodine will be applied to the lower anterior nares (i.e. nostril) of patients undergoing HELEF orthopedic repair. | Drug | Nasal Povidone-Iodine Decolonization Intervention |
Primary outcome
Incidence of Complex (deep incisional or organ space) Staphylococcus aureus surgical site infection (SSI)
Time frame: within 180 days of the initial surgical procedure for HELEF repair
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
5 secondary outcomes
Incidence of all Staphylococcus aureus SSI
Time frame: within 180 days of the initial surgical procedure for HELEF repair
Incidence of all Complex SSI
Time frame: within 180 days of the initial surgical procedure for HELEF repair
Incidence of all gram-negative Complex SSI
Time frame: within 180 days of the initial surgical procedure for HELEF repair
Incidence of cellulitis involving the surgical site
Time frame: within 180 days of the initial surgical procedure for HELEF repair
Clavien-Dindo assessment of postoperative complications scores
Time frame: within 180 days of the initial surgical procedure for HELEF repair
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loreen Herwaldt, MD principal investigator
University of Iowa
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing povidone-iodine topical ointment in people with Surgical Site Infection, run by Loreen Herwaldt at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Complex (deep incisional or organ space) Staphylococcus aureus surgical site infection (SSI) (time frame: within 180 days of the initial surgical procedure for HELEF repair). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.