Nasal Decolonization of Dialysis Patients Noses — PAINTS  

Staphylococcus Aureus Infection Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Infections
• Staphylococcal Infections
• Staphylococcus Aureus Infection

• NCT number: NCT04210505
• Study type: Interventional
• Source: University of Iowa
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: September 29, 2020
• Completion date: January 31, 2024