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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04146116
Other study ID # 201812801
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date February 19, 2020
Est. completion date June 8, 2021

Study information

Verified date June 2023
Source University of Iowa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Description:

Aim 1. Evaluate the real-world effectiveness of intranasal povidone-iodine (PROFENDĀ®) 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.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date June 8, 2021
Est. primary completion date June 8, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
intranasal povidone-iodine
povidone-iodine USP, 10% w/w antiseptic

Locations

Country Name City State
United States University of Iowa Hospitals and Clinics Iowa City Iowa

Sponsors (2)

Lead Sponsor Collaborator
University of Iowa Professional Disposables International, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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). Within 6 hours after first dose of povidone-iodine
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). 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. Within 30 days of surgery
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