Recruitment

Recruitment Status
Enrolling by invitation
Estimated Enrollment
Same as current

Summary

Conditions
Surgical Site Infection
Type
Interventional
Phase
Phase 4
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: 50 patients will receive PROFEND intranasal povidone-iodine prior to surgery and after surgery. The study aims to evaluate the real-world effectiveness of PROFEND® in reducing S. aureus colonization and surgical site infections (SSIs).Masking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Aim 1. Evaluate the real-world effectiveness of intranasal povidone-iodine (PROFEND®) in reducing Staphylococcus aureus colonization and surgical site infections (SSIs). Aim 1a. Evaluate patients after surgery to determine S. aureus colonization and to survey patients on tolerability of intranasal p...

Aim 1. Evaluate the real-world effectiveness of intranasal povidone-iodine (PROFEND®) in reducing Staphylococcus aureus colonization and surgical site infections (SSIs). Aim 1a. Evaluate patients after surgery to determine S. aureus colonization and to survey patients on tolerability of intranasal povidone-iodine decolonization. The intranasal povidone-iodine swab will be administered to the patient's nares around one hour prior to the first surgical incision. It will then be re-applied around 12 hours later, for a total of two applications within a 24 hour period. During the same visit at 24 hours after surgery, patients will also be administered a questionnaire to determine the tolerability of intranasal povidone-iodine decolonization. Questions will be asked about adverse events (e.g., itching, irritation) and how intranasal povidone-iodine felt (very pleasant, pleasant, neutral, unpleasant, very unpleasant). Based on the data obtained from this aim, we will summarize the patient acceptance of intranasal povidone-iodine. Aim 1b. Compare the rates of SSI among orthopaedic trauma surgery patients who received intranasal povidone-iodine to similar patients who received orthopedic trauma surgery before intranasal povidone-iodine implementation.

Tracking Information

NCT #
NCT04146116
Collaborators
Professional Disposables International, Inc.
Investigators
Principal Investigator: Marin L Schweizer, PhD University of Iowa