NCT04146116

Nasal Decolonization for Orthopedic Trauma Patients

Feasibility of Pre-operative Povidone Iodine Decolonization Among Orthopedic Trauma Surgery Patients To Reduce Staphylococcus Aureus Surgical Site Infections

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: University of Iowa · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Many surgical site infections are caused by bacteria that is transferred from a patient's nose to their open surgical wound. Some small studies have shown that putting povidone-iodine in a patient's nose reduces this risk. This study aims to evaluate the real-world effectiveness of nasal povidone-iodine (PROFEND®) in a group of 50 patients at the University of Iowa.

Detailed 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 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.

Conditions

• Surgical Site Infection

Interventions

Type	Name	Description
DRUG	intranasal povidone-iodine	povidone-iodine USP, 10% w/w antiseptic

Timeline

• Start date: 2020-02-19
• Primary completion: 2021-06-08
• Completion: 2021-06-08
• First posted: 2019-10-31
• Last updated: 2023-06-28
• Results posted: 2023-06-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study