Surgical Site InfectionPhase 4NCT04146116
Nasal Decolonization for Orthopedic Trauma Patients
A Phase 4 study testing intranasal povidone-iodine in people with Surgical Site Infection, run by University of Iowa at 1 site in United States.
Trial summary
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. 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?
- intranasal povidone-iodine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2020to 8 Jun 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients undergoing operative fixation of lower extremity fractures at the University of Iowa during the study period.
Who cannot join
- Patients unable to provide informed consent due to head trauma or dementia.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
Official title: Feasibility of Pre-operative Povidone Iodine Decolonization Among Orthopedic Trauma Surgery Patients To Reduce Staphylococcus Aureus Surgical Site Infections
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.
Read the detailed description
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.
- Conditions
- Surgical Site Infection
- Being tested
- intranasal povidone-iodine
- Keywords
- nasal decolonization, Orthopedic trauma surgery
- 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.
intranasal povidone-iodineDrug
Also called PROFEND
povidone-iodine USP, 10% w/w antiseptic
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: intranasal povidone-iodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within 6 hours after first dose of povidone-iodine
Secondary outcomes (2)
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).
Measured: 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.
Measured: Within 30 days of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start19 Feb 2020
- Primary completion8 Jun 2021
- Study completion8 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- Professional Disposables International, Inc.
- Responsible party
- Principal investigator, Marin L. Schweizer, PhD, University of Iowa
- Investigators
- Marin L Schweizer, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146116
- Sponsor's protocol ID
- 201812801
- Status last verified
- Jun 2023
- First submitted
- 29 Oct 2019
- Last updated
- 28 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Pre-operative Povidone Iodine Decolonization Among Orthopedic Trauma Surgery Patients To Reduce Staphylococcus Aureus Surgical Site Infections
- ClinicalTrials.gov ID
- NCT04146116
- Acronym / sponsor ID
- 201812801
- Conditions
- Surgical Site Infection
- Keywords
- nasal decolonization, Orthopedic trauma surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- Professional Disposables International, Inc.
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- 8 Jun 2021 (actual)
- Study completion
- 8 Jun 2021 (actual)
- First posted
- 31 Oct 2019 (actual)
- Results
- Posted 28 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Nasal povidone-iodine | Experimental | Drug: intranasal povidone-iodineIntranasal 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing operative fixation of lower extremity fractures at the University of Iowa during the study period.
Key exclusion criteria (1 listed)
- Patients unable to provide informed consent due to head trauma or dementia.
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 |
|---|---|---|
| intranasal povidone-iodineAlso: PROFENDpovidone-iodine USP, 10% w/w antiseptic | Drug | Nasal povidone-iodine |
Primary outcome
Number of Participants With Staphylococcus Aureus Nasal Colonization
Time frame: Within 6 hours after first dose of povidone-iodine
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).
2 secondary outcomes
Number of Participants With Staphylococcus Aureus Nasal Colonization
Time frame: Within 24 hours after surgery
Number of Participants With Surgical Site Infection
Time frame: Within 30 days of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Marin L Schweizer, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing intranasal povidone-iodine in people with Surgical Site Infection, run by University of Iowa at 1 site 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 28 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Staphylococcus Aureus Nasal Colonization (time frame: Within 6 hours after first dose of povidone-iodine). 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 28 Jun 2023.