Phase 4
N=65
Nasal Decolonization for Orthopedic Trauma Patients
Surgical Site Infection
Bottom Line
View on ClinicalTrials.gov: NCT04146116 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Number of Participants With Staphylococcus Aureus Nasal Colonization — 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- intranasal povidone-iodine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Iowa
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Staphylococcus Aureus Nasal Colonization |
2 | — |
| SECONDARY Number of Participants With Staphylococcus Aureus Nasal Colonization |
2 | — |
| SECONDARY Number of Participants With Surgical Site Infection |
— | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- Patients undergoing operative fixation of lower extremity fractures at the University of Iowa during the study period.
Exclusion Criteria
- Patients unable to provide informed consent due to head trauma or dementia.
Data sourced from ClinicalTrials.gov (NCT04146116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.