Clinical trial NCT04146116: Nasal Decolonization for Orthopedic Trauma Patients
Official title: Feasibility of Pre-operative Povidone Iodine Decolonization Among Orthopedic Trauma Surgery Patients To Reduce Staphylococcus Aureus Surgical Site Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Surgical Site Infection
Keywords: nasal decolonization
Orthopedic trauma surgery
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Professional Disposables International, Inc.
First posted: 2019-10-31
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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).
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Number of Participants With Staphylococcus Aureus Nasal Colonization
timeFrame: Within 6 hours after first dose of povidone-iodine
Secondary outcomes:
measure: Number of Participants With Staphylococcus Aureus Nasal Colonization
timeFrame: Within 24 hours after surgery
measure: Number of Participants With Surgical Site Infection
timeFrame: Within 30 days of surgery
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Marin L Schweizer, PhD
role: PRINCIPAL_INVESTIGATOR
References: