Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections

Last updated: February 14, 2025
Sponsor: Ondine Biomedical Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Pressure Ulcer

Treatment

nasal antimicrobial photodisinfection therapy

Clinical Study ID

NCT06702878
OBI-NPDT-SSI-004
  • Ages > 18
  • All Genders

Study Summary

This is a Phase 3 multi-center, group-randomized, crossover trial to compare nasal antimicrobial photodisinfection therapy (aPDT) with standard of care for prevention of surgical site infections in patients undergoing major elective, urgent, or emergent surgeries in a hospital setting. The main outcomes are to:

  1. compare the efficacy, and

  2. estimate the safety of applying nasal (aPDT) before surgery in reducing the incidence of SSIs within the initial 30 days after surgery compared to standard of care (SOC).

Participants in the intervention group will receive aPDT prior to surgery on the day of surgery.

Participants in the control group will receive standard of care surgical site prevention measures prior to surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Surgical patients, willing to sign the informed consent form and participate in thestudy.

  2. ≥ 18 years of age

  3. Presenting to an acute care hospital for major elective, urgent, or emergencysurgery, defined as an open procedure involving a significant skin incision,including the following types:

  4. Cardiac

  5. Vascular

  6. Orthopedic, including spine and 'clean' trauma

  7. Neurosurgery

  8. Radical breast surgeries (radical mastectomy with or without reconstruction)

  9. Are able to follow instructions, comply with protocol requirements, and participatein all required study visits.

Exclusion

Exclusion Criteria:

  1. Pregnancy (current) or currently lactating. If patient is unsure of pregnancystatus, a negative urine or serum pregnancy test (sensitive to 25 IU hCG) should beobtained within 14 days prior to surgery.

  2. Surgical indication of infection.

  3. History of surgery within 30 days prior to enrollment.

  4. Anticipated surgery other than the index surgical procedure prior to patient'scompletion of the study.

  5. Patient has any medical, social or psychiatric condition(s) or current substanceabuse condition that, in the opinion of the investigator, would preclude thepatient's ability to provide informed consent, or to comply with the studyrequirements.

  6. Enrollment in concomitant investigational research study in the past 30 days. Exclusion Criteria Specific to Treatment Group Patients Only:

  7. Inability to tolerate insertion of the nasal light illuminator due to nasalobstructions or nares size, shape, or anatomical variants.

  8. Known allergic reactions to components of the nasal disinfection treatment includingmethylene blue or chlorhexidine gluconate. Exclusion Criteria Specific to the Nasal Microbiota Substudy Only:

  9. Use of other nasal decolonization procedures prior to surgery (mupirocin, povidoneiodine, alcohol other).

Study Design

Total Participants: 4514
Treatment Group(s): 1
Primary Treatment: nasal antimicrobial photodisinfection therapy
Phase: 3
Study Start date:
December 27, 2024
Estimated Completion Date:
August 31, 2025

Study Description

This study employs a group-randomized crossover design, comparing outcomes from the treatment group with that of a standard-of-care control group from the same hospitals. Each hospital ('site') engaged in the study will be randomly assigned to treatment plus standard-of-care or standard-of-care control on a 1:1 basis and will enroll patients into those respective groups during the first period of the study. After an approximate 6-week inactive interval period, each site will crossover to enroll the alternate group, up to a number of patients that matches the site's first period (or up to 10% more).

Eligible patients who successfully complete all screening assessments and meet inclusion and exclusion criteria will be enrolled. Patients in the treatment group will undergo aPDT treatment after admission to the preoperative area. All patients will be followed up for a 30-day post-surgery period. A patient-reported outcome (PRO) assessment to gauge the tolerability of the intervention after administration will also be performed in the treatment group.

Standard-of-care infection control practices will be applied according to infection prevention policies and procedures in place at each hospital. These practices are to remain unchanged for both groups throughout the study.

Microbiological samples will also be collected from any SSI and evaluated to establish the causative organism and its antibiotic susceptibility.

The incidence of SSIs during the 30-day postoperative period will be tracked to ensure comprehensive follow-up evaluations. In-person unscheduled visits will be conducted for medical assessment of suspected SSIs and collection of wound cultures.

Nasal Microbiota Substudy Approximately 500 study patients will have pre-treatment and post-treatment nasal swabs (in the treatment group) or single pre-surgical nasal swabs (in the control group) collected and stored. These samples will be processed for quantitative microbiological evaluation of S. aureus.

Connect with a study center

  • HCA Brandon Florida

    Brandon, Florida 33511
    United States

    Active - Recruiting

  • HCA Florida Largo Hospital

    Largo, Florida 33770
    United States

    Active - Recruiting

  • HCA Florida NorthSide Hospital

    St. Petersburg, Florida 33709
    United States

    Active - Recruiting

  • HCA Florida Trinity Hospital

    Trinity, Florida 34655
    United States

    Active - Recruiting

  • Centennial Medical Center

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Medical City Frisco Hospital

    Frisco, Texas 75034
    United States

    Active - Recruiting

  • Medical City Plano

    Plano, Texas 75075
    United States

    Active - Recruiting

  • Methodist Main Hospital

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Methodist Stone Oak

    San Antonio, Texas 78258
    United States

    Active - Recruiting

  • Johnston Willis Hospital

    Richmond, Virginia 23235
    United States

    Site Not Available

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