Nasal Decolonization for Orthopedic Trauma Patients

Phase 4

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Patients undergoing operative fixation of lower extremity fractures at the University of Iowa during the study period.

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Nasal povidone-iodine	intranasal povidone-iodine	Intranasal povidone-iodine (PDI PROFEND) will be applied to the patients' noses before orthopedic trauma surgery and after surgery. This intranasal 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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Staphylococcus Aureus Nasal Colonization	Within 6 hours after first dose of povidone-iodine	A dry, sterile, rayon swab will be used to sample the anterior apex portion of the right and left nostril. This swab will be tested for S. aureus bacteria. If bacteria are found in either nostril, the participant is categorized as being colonized with S. aureus (e.g. carries the bacteria in their nose with no signs or symptoms of infection).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Staphylococcus Aureus Nasal Colonization	Within 24 hours after surgery	A dry, sterile, rayon swab will be used to sample the anterior apex portion of the right and left nostril. This swab will be tested for S. aureus bacteria. This swab will be tested for S. aureus bacteria. If bacteria are found in either nostril, the participant is categorized as being colonized with S. aureus (e.g. carries the bacteria in their nose with no signs or symptoms of infection).
Number of Participants With Surgical Site Infection	Within 30 days of surgery	Surgical site infection as defined by the Centers for Disease Control and Prevention National Healthcare Safety Network.