NCT04210505

Nasal Decolonization of Dialysis Patients Noses

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 302 (actual)
• Sponsor: Marin L. Schweizer, PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Staphylococcus Aureus Infection

Interventions

Type	Name	Description
DRUG	Povidone-Iodine Topical Ointment	Intranasal povidone-iodine will be applied to the lower anterior nares (i.e. nostril) of patients undergoing hemodialysis before each session.
OTHER	Standard Care	Control group will receive standard care as provided by the dialysis center

Timeline

• Start date: 2020-09-29
• Primary completion: 2024-01-31
• Completion: 2024-01-31
• First posted: 2019-12-24
• Last updated: 2023-06-28

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study