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| Name | Class |
|---|---|
| Professional Disposables International, Inc. | INDUSTRY |
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Many surgical site infections are caused by bacteria that is transferred from a patient's nose to their open surgical wound. Some small studies have shown that putting povidone-iodine in a patient's nose reduces this risk. This study aims to evaluate the real-world effectiveness of nasal povidone-iodine (PROFEND®) in a group of 50 patients at the University of Iowa.
Aim 1. Evaluate the real-world effectiveness of intranasal povidone-iodine (PROFEND®) in reducing Staphylococcus aureus colonization and surgical site infections (SSIs).
Aim 1a. Evaluate patients after surgery to determine S. aureus colonization and to survey patients on tolerability of intranasal povidone-iodine decolonization. The intranasal povidone-iodine swab will be administered to the patient's nares around one hour prior to the first surgical incision. It will then be re-applied around 12 hours later, for a total of two applications within a 24 hour period.
During the same visit at 24 hours after surgery, patients will also be administered a questionnaire to determine the tolerability of intranasal povidone-iodine decolonization. Questions will be asked about adverse events (e.g., itching, irritation) and how intranasal povidone-iodine felt (very pleasant, pleasant, neutral, unpleasant, very unpleasant).
Based on the data obtained from this aim, we will summarize the patient acceptance of intranasal povidone-iodine.
Aim 1b. Compare the rates of SSI among orthopaedic trauma surgery patients who received intranasal povidone-iodine to similar patients who received orthopedic trauma surgery before intranasal povidone-iodine implementation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal povidone-iodine | Experimental | Intranasal povidone-iodine (PDI PROFEND) will be applied to the patients' noses before orthopedic trauma surgery and after surgery. This intranasal povidone-iodine was developed under the Tentative Final Monograph for Health-Care Antiseptic Drug Products 21 CFR Parts 333 and 369 (Docket # 75N-183H), Federal Register Volume 59, Number 116, Friday, June 17, 1994, Proposed Rules. However, the product need not be controlled like a pharmaceutical drug. The product may be stored and controlled similarly to an iodine or alcohol skin preparation product. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intranasal povidone-iodine | Drug | povidone-iodine USP, 10% w/w antiseptic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Staphylococcus Aureus Nasal Colonization | A dry, sterile, rayon swab will be used to sample the anterior apex portion of the right and left nostril. This swab will be tested for S. aureus bacteria. If bacteria are found in either nostril, the participant is categorized as being colonized with S. aureus (e.g. carries the bacteria in their nose with no signs or symptoms of infection). | Within 6 hours after first dose of povidone-iodine |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Staphylococcus Aureus Nasal Colonization | A dry, sterile, rayon swab will be used to sample the anterior apex portion of the right and left nostril. This swab will be tested for S. aureus bacteria. This swab will be tested for S. aureus bacteria. If bacteria are found in either nostril, the participant is categorized as being colonized with S. aureus (e.g. carries the bacteria in their nose with no signs or symptoms of infection). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marin L Schweizer, PhD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
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Obtained informed consent in the day of surgery area of the hospital prior to surgery.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nasal Povidone-iodine | Intranasal povidone-iodine (PDI PROFEND) will be applied to the patients' noses before orthopedic trauma surgery and after surgery. This intranasal povidone-iodine was developed under the Tentative Final Monograph for Health-Care Antiseptic Drug Products 21 CFR Parts 333 and 369 (Docket # 75N-183H), Federal Register Volume 59, Number 116, Friday, June 17, 1994, Proposed Rules. However, the product need not be controlled like a pharmaceutical drug. The product may be stored and controlled similarly to an iodine or alcohol skin preparation product. intranasal povidone-iodine: povidone-iodine USP, 10% w/w antiseptic |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients who received orthopedic trauma surgery who consented to the intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Nasal Povidone-iodine | Intranasal povidone-iodine (PDI PROFEND) will be applied to the patients' noses before orthopedic trauma surgery and after surgery. This intranasal povidone-iodine was developed under the Tentative Final Monograph for Health-Care Antiseptic Drug Products 21 CFR Parts 333 and 369 (Docket # 75N-183H), Federal Register Volume 59, Number 116, Friday, June 17, 1994, Proposed Rules. However, the product need not be controlled like a pharmaceutical drug. The product may be stored and controlled similarly to an iodine or alcohol skin preparation product. intranasal povidone-iodine: povidone-iodine USP, 10% w/w antiseptic |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Not collected. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Staphylococcus Aureus Nasal Colonization | A dry, sterile, rayon swab will be used to sample the anterior apex portion of the right and left nostril. This swab will be tested for S. aureus bacteria. If bacteria are found in either nostril, the participant is categorized as being colonized with S. aureus (e.g. carries the bacteria in their nose with no signs or symptoms of infection). | All patients who received 2 doses of nasal povidone-iodine (pre-surgery and post-surgery) | Posted | Count of Participants | Participants | Within 6 hours after first dose of povidone-iodine |
|
Within 24 hours of initial application
Collected via survey
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nasal Povidone-iodine | Intranasal povidone-iodine (PDI PROFEND) will be applied to the patients' noses before orthopedic trauma surgery and after surgery. This intranasal povidone-iodine was developed under the Tentative Final Monograph for Health-Care Antiseptic Drug Products 21 CFR Parts 333 and 369 (Docket # 75N-183H), Federal Register Volume 59, Number 116, Friday, June 17, 1994, Proposed Rules. However, the product need not be controlled like a pharmaceutical drug. The product may be stored and controlled similarly to an iodine or alcohol skin preparation product. intranasal povidone-iodine: povidone-iodine USP, 10% w/w antiseptic |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stinging in the Nose | Product Issues | Systematic Assessment | Stinging in the nose assessed within 24 hours of initial application |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marin Schweizer | University of Wisconsin, Madison | 6082631545 | mschweizer@medicine.wisc.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 18, 2019 | Dec 30, 2022 | Prot_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 16, 2019 | Nov 8, 2022 | ICF_001.pdf |
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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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50 patients will receive PROFEND intranasal povidone-iodine prior to surgery and after surgery. The study aims to evaluate the real-world effectiveness of PROFEND® in reducing S. aureus colonization and surgical site infections (SSIs).
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| Within 24 hours after surgery |
| Number of Participants With Surgical Site Infection | Surgical site infection as defined by the Centers for Disease Control and Prevention National Healthcare Safety Network. | Within 30 days of surgery |
| Participants |
|
| Sex/Gender, Customized | Not collected | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
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| Secondary | Number of Participants With Staphylococcus Aureus Nasal Colonization | A dry, sterile, rayon swab will be used to sample the anterior apex portion of the right and left nostril. This swab will be tested for S. aureus bacteria. This swab will be tested for S. aureus bacteria. If bacteria are found in either nostril, the participant is categorized as being colonized with S. aureus (e.g. carries the bacteria in their nose with no signs or symptoms of infection). | Posted | Count of Participants | Participants | Within 24 hours after surgery |
|
|
|
| Secondary | Number of Participants With Surgical Site Infection | Surgical site infection as defined by the Centers for Disease Control and Prevention National Healthcare Safety Network. | Posted | Count of Participants | Participants | Within 30 days of surgery |
|
|
|
| 0 |
| 51 |
| 0 |
| 51 |
| 6 |
| 51 |
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| Burning sensation | Product Issues | Systematic Assessment | Burning sensation in the nose assessed within 24 hours of initial application |
|
| Sore Throat | Product Issues | Systematic Assessment | Sore throat assessed within 24 hours of initial application |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Cough assessed within 24 hours of initial application |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |