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Nasal light zaps infection risk before surgery

NCT ID NCT06702878

Prevention Sponsor: Ondine Biomedical Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 2 times

Summary

This study tested a new way to prevent surgical site infections by using a special light treatment inside the nose just before surgery. Over 4,700 adults having major surgeries like heart, spine, or joint replacement took part. The goal was to see if this light therapy reduces infections within 30 days after surgery compared to standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

4,787 people

The number who actually took part.

Started

Dec 2024

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Surgical patients, willing to sign the informed consent form and participate in the study. 2. ≥ 18 years of age 3. Presenting to an acute care hospital for major elective, urgent, or emergency surgery, defined as an open procedure involving a significant skin incision, including but not limited to the following types: 1. Cardiac 2. Vascular 3. Orthopedic, including spine and 'clean' trauma 4. Neurosurgery 5. Breast surgeries 4. Are able to follow instructions, comply with protocol requirements, and participate in all required study visits. Exclusion Criteria: 1. Pregnancy (current) or currently lactating. If patient is unsure of pregnancy status, a negative urine or serum pregnancy test (sensitive to 25 IU hCG) should be obtained within 14 days prior to surgery. 2. Surgical indication of infection. 3. History of surgery within 90 days prior to enrollment. 4. Anticipated surgery other than the index surgical procedure prior to patient's completion of the study. 5. Use of other nasal decolonization procedures on the day of surgery prior to the index procedure (mupirocin, povidone iodine, alcohol, etc.). 6. Patient has any medical, social or psychiatric condition(s) or current substance abuse condition that, in the opinion of the investigator, would preclude the patient's ability to provide informed consent, or to comply with the study requirements. 7. Enrollment in concomitant investigational research study in the past 30 days. Exclusion Criteria Specific to Treatment Group Patients Only: 8. Inability to tolerate insertion of the nasal light illuminator due to nasal obstructions or nares size, shape, or anatomical variants. 9. Known allergic reactions to components of the nasal disinfection treatment including methylene blue or chlorhexidine gluconate.

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Conditions

The condition(s) this trial relates to.

Infections infectious disease staphylococcal infection Surgical Wound Infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anti-infective agents Infections Surgical site infections Surgical wound infection

Contacts and locations

Locations

  • Centennial Medical Center

    Nashville, Tennessee, 37203, United States

  • HCA Brandon Florida

    Brandon, Florida, 33511, United States

  • HCA Florida Largo Hospital

    Largo, Florida, 33770, United States

  • HCA Florida NorthSide Hospital

    St. Petersburg, Florida, 33709, United States

  • HCA Florida Trinity Hospital

    Trinity, Florida, 34655, United States

  • HCA Houston Healthcare Clear Lake Hospital

    Webster, Texas, 77598, United States

  • HCA Houston Healthcare Kingwood

    Kingwood, Texas, 77339, United States

  • Johnston Willis Hospital

    Richmond, Virginia, 23235, United States

  • Medical City Frisco Hospital

    Frisco, Texas, 75034, United States

  • Medical City Plano

    Plano, Texas, 75075, United States

  • Methodist Main Hospital and Landmark

    San Antonio, Texas, 78229, United States

  • Methodist Metropolitan Hospital

    San Antonio, Texas, 78212, United States

  • Methodist Stone Oak

    San Antonio, Texas, 78258, United States

  • Swedish Medical Center

    Englewood, Colorado, 80113, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.