Nasal Decolonization of Dialysis Patients Noses

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Povidone-iodine to Stop Access-related Infections and Transmission of Staphylococcus Aureus (PAINTS)

Conditions
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Staphylococcus Aureus Infection

Intervention / Treatment
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* Drug: Povidone-Iodine Topical Ointment
* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients receiving outpatient chronic hemodialysis at one of the 16 study dialysis centers. Note: the unit of randomization is the dialysis center, not the individual patient Exclusion Criteria: Patients receiving peritoneal dialysis or home hemodialysis Pregnant women Patients with known sensitivity or allergy to iodine (documented or verbalized) Patients with active bacterial infections Children < 18 years of age. Patients with infections at the beginning of the study will enter the study after antibiotic treatment is complete.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nasal Povidone-Iodine Decolonization Intervention<br>Intranasal povidone-iodine (3M Skin and Nasal Antiseptic) will be applied to the patients' noses at each hemodialysis session. | Drug: Povidone-Iodine Topical Ointment<br>* Intranasal povidone-iodine will be applied to the lower anterior nares (i.e. nostril) of patients undergoing hemodialysis before each session.<br>Other: Standard Care<br>* Control group will receive standard care as provided by the dialysis center<br>|
| No Intervention: Concurrent Control<br>Standard of Care. This will be usual care at each hemodialysis center. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Through study completion (up to 3 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | Through study completion (up to 3 years) | 
| 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 | 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 | Through study completion (up to 3 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dialysis, povidone-iodine