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Completed

NCT Number: NCT04146116

Nasal Decolonization for Orthopedic Trauma Patients

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.

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Key information

Conditions

Surgical Site Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients unable to provide informed consent due to head trauma or dementia.

Treatment and study plan

intranasal povidone-iodine

Drug

povidone-iodine USP, 10% w/w antiseptic

Other names: PROFEND

Primary outcomes

  1. Number of Participants With Staphylococcus Aureus Nasal Colonization

    Time frame: 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 outcomes

  1. Number of Participants With Staphylococcus Aureus Nasal Colonization

    Time frame: 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).

  2. Number of Participants With Surgical Site Infection

    Time frame: Within 30 days of surgery

    Surgical site infection as defined by the Centers for Disease Control and Prevention National Healthcare Safety Network.

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Collaborators

  • Professional Disposables International, Inc.

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 31, 2019
Registry last updated
Jun 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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