Nasal Decolonization of Dialysis Patients Noses
- Conditions
- Staphylococcus Aureus Infection
- Interventions
- Other: Standard Care
- Registration Number
- NCT04210505
- Lead Sponsor
- Marin L. Schweizer, PhD
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 302
- 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
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nasal Povidone-Iodine Decolonization Intervention Povidone-Iodine Topical Ointment Intranasal povidone-iodine (3M Skin and Nasal Antiseptic) will be applied to the patients' noses at each hemodialysis session. Nasal Povidone-Iodine Decolonization Intervention Standard Care Intranasal povidone-iodine (3M Skin and Nasal Antiseptic) will be applied to the patients' noses at each hemodialysis session.
- Primary Outcome Measures
Name Time Method Incidence of Staphylococcus aureus bloodstream infection Through study completion (up to 3 years) 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
- Secondary Outcome Measures
Name Time Method Incidence of Bloodstream infections by any pathogen Through study completion (up to 3 years) 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
Incidence of Staphylococcus aureus local access site infection Through study completion (up to 3 years) 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
Incidence of Staphylococcus aureus access related bloodstream infection (ARBSI) Through study completion (up to 3 years) 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
Incidence of Local access site infection Through study completion (up to 3 years) 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
Incidence of Access related bloodstream infection by any pathogen Through study completion (up to 3 years) 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
Incidence of Staphylococcus aureus bloodstream infection among patients who agreed to participate in intervention Through study completion (up to 3 years) Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network
Trial Locations
- Locations (5)
Washington University
🇺🇸Saint Louis, Missouri, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Emory Healthcare
🇺🇸Atlanta, Georgia, United States
University of Illinois Chicago
🇺🇸Chicago, Illinois, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States