Hemodialysis patients are at high-risk for infections, specifically Staphylococcus aureus infections. The investigators propose to 1) implement a novel intervention (nasal povidone-iodine at each hemodialysis session) to prevent S. aureus infections using a stepped-wedge cluster randomized trial, and 2) evaluate the feasibility and acceptability of this intervention. If successful, this intervention can be used among hemodialysis patients, and evaluated in other high-risk patient populations to prevent S. aureus infections.
The PAINTS study is a stepped-wedge cluster randomized trial that will compare standard care to an intervention that includes nasal povidone-iodine at each hemodialysis session to determine whether nasal povidone-iodine prevents infections. The nasal povidone-iodine will be donated by 3M. This formulation of nasal 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
302
Intranasal povidone-iodine will be applied to the lower anterior nares (i.e. nostril) of patients undergoing hemodialysis before each session.
Control group will receive standard care as provided by the dialysis center
Emory Healthcare
Atlanta, Georgia, United States
University of Illinois Chicago
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Washington University
St Louis, Missouri, United States
Incidence of Staphylococcus aureus bloodstream infection
Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) definition: a Staphylococcus aureus positive blood specimen collected in the outpatient setting or within 1 calendar day after a hospital admission
Time frame: Through study completion (up to 3 years)
Incidence of Staphylococcus aureus access related bloodstream infection (ARBSI)
Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) definition: a Staphylococcus aureus bloodstream infection with the suspected source reported as the vascular access or uncertain
Time frame: Through study completion (up to 3 years)
Incidence of Staphylococcus aureus local access site infection
Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) definition: pus, redness or increased swelling at the vascular access site when an ARBSI is not present but with positive culture for Staphylococcus aureus
Time frame: Through study completion (up to 3 years)
Incidence of Bloodstream infections by any pathogen
Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network definition: a positive blood specimen collected in the outpatient setting or within 1 calendar day after a hospital admission
Time frame: Through study completion (up to 3 years)
Incidence of Access related bloodstream infection by any pathogen
Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network definition: a bloodstream infection with the suspected source reported as the vascular access or uncertain
Time frame: Through study completion (up to 3 years)
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
Incidence of Local access site infection
Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) definition: pus, redness or increased swelling at the vascular access site when an ARBSI is not present
Time frame: Through study completion (up to 3 years)
Incidence of Staphylococcus aureus bloodstream infection among patients who agreed to participate in intervention
Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network
Time frame: Through study completion (up to 3 years)