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| ID | Type | Description | Link |
|---|---|---|---|
| U54CK000613 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Indiana University | OTHER |
| University of Utah | OTHER |
| Washington University School of Medicine | OTHER |
| University of Texas |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Concurrent Control | No Intervention | Standard of Care. This will be usual care at each participating site for subjects enrolled in the Baseline period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | within 180 days of the initial surgical procedure for HELEF repair |
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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:
Examples of included procedures:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Loreen Herwaldt, MD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30303 | United States | ||
| University of Indiana |
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.
Until year 2026
Upon request
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| OTHER |
| Emory University | OTHER |
| PDI Healthcare | UNKNOWN |
| Centers for Disease Control and Prevention | FED |
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|
| 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 |
| 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 | 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. | 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/ | within 180 days of the initial surgical procedure for HELEF repair |
| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |