Surgical Site Infection
Conditions
Keywords
nasal decolonization, Orthopedic trauma surgery
Brief 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.
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.
Interventions
DRUGintranasal povidone-iodine
povidone-iodine USP, 10% w/w antiseptic
Sponsors
Professional Disposables International, Inc.
University of Iowa
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Staphylococcus Aureus Nasal Colonization | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Staphylococcus Aureus Nasal Colonization | Within 24 hours after surgery | 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). |
| Number of Participants With Surgical Site Infection | Within 30 days of surgery | Surgical site infection as defined by the Centers for Disease Control and Prevention National Healthcare Safety Network. |
Countries
United States
Participant flow
Recruitment details
Obtained informed consent in the day of surgery area of the hospital prior to surgery.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 51 |
| Total | 51 |
Baseline characteristics
| Characteristic | — | Nasal Povidone-iodine |
|---|---|---|
| Age, Customized Age | — Participants | — |
| Race and Ethnicity Not Collected | — Participants | — |
| Region of Enrollment United States | — | 51 participants |
| Sex/Gender, Customized Gender | — Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 51 |
| other Total, other adverse events | 6 / 51 |
| serious Total, serious adverse events | 0 / 51 |
Outcome results
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).
Time frame: Within 6 hours after first dose of povidone-iodine
Population: All patients who received 2 doses of nasal povidone-iodine (pre-surgery and post-surgery)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nasal Povidone-iodine | Number of Participants With Staphylococcus Aureus Nasal Colonization | 12 Participants |
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).
Time frame: Within 24 hours after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nasal Povidone-iodine | Number of Participants With Staphylococcus Aureus Nasal Colonization | 2 Participants |
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.
Time frame: Within 30 days of surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nasal Povidone-iodine | Number of Participants With Surgical Site Infection | 0 Participants |