Surgical Site InfectionsPhase 3LANTERNNCT06702878
Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections
A Phase 3 study testing nasal antimicrobial photodisinfection therapy in people with Surgical Site Infections and Surgical Wound Infection, run by Ondine Biomedical Inc. at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infections, Surgical Wound Infection, Infections
- What is being tested?
- nasal antimicrobial photodisinfection therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,787 participants
- Where
- 14 sitesUnited States
- Study dates
- 27 Dec 2024to 7 May 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgical patients, willing to sign the informed consent form and participate in the study.
- ≥ 18 years of age
- 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:
- Cardiac
- Vascular
- Orthopedic, including spine and 'clean' trauma
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- Neurosurgery
- Breast surgeries
- Are able to follow instructions, comply with protocol requirements, and participate in all required study visits.
Who cannot join
- 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.
- Surgical indication of infection.
- History of surgery within 90 days prior to enrollment.
- Anticipated surgery other than the index surgical procedure prior to patient's completion of the study.
- Use of other nasal decolonization procedures on the day of surgery prior to the index procedure (mupirocin, povidone iodine, alcohol, etc.).
- 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.
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- Enrollment in concomitant investigational research study in the past 30 days.
- Exclusion Criteria Specific to Treatment Group Patients Only:
- Inability to tolerate insertion of the nasal light illuminator due to nasal obstructions or nares size, shape, or anatomical variants.
- Known allergic reactions to components of the nasal disinfection treatment including methylene blue or chlorhexidine gluconate.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
HCA Brandon Florida
Brandon, Florida, 33511
Swedish Medical Center
Englewood, Colorado, 80113
Medical City Frisco Hospital
Frisco, Texas, 75034
HCA Houston Healthcare Kingwood
Kingwood, Texas, 77339
HCA Florida Largo Hospital
Largo, Florida, 33770
Centennial Medical Center
Nashville, Tennessee, 37203
Medical City Plano
Plano, Texas, 75075
Johnston Willis Hospital
Richmond, Virginia, 23235
Methodist Metropolitan Hospital
San Antonio, Texas, 78212
Methodist Main Hospital and Landmark
San Antonio, Texas, 78229
Methodist Stone Oak
San Antonio, Texas, 78258
HCA Florida NorthSide Hospital
St. Petersburg, Florida, 33709
HCA Florida Trinity Hospital
Trinity, Florida, 34655
HCA Houston Healthcare Clear Lake Hospital
Webster, Texas, 77598
About this study
Official title: A Group-Randomized, Standard-of-Care-Controlled, Crossover Trial Evaluating Nasal Antimicrobial Photodisinfection for the Prevention of Surgical Site Infections
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:
- compare the efficacy, and
- 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).
Read more
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.
Read the detailed 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.
- Being tested
- nasal antimicrobial photodisinfection therapy
- Keywords
- Surgical site infection, nasal decolonization, photodisinfection, nasal photodisinfection, Staphylococcus aureus, Photodynamic therapy, Methylene Blue, chlorhexidine, Disinfection
- Medical subject headings
- Surgical Wound Infection, Infections, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal antimicrobial photodisinfection therapyCombination product
Application of NF-031 solution (methylene blue 0.01% USP (methylthioninium chloride) and 0.25% chlorhexidine gluconate) in the nares followed by 2-minutes of light with nasal illuminators. The application is repeated a second time for total treatment time of 5-minutes.
| Study group | Role | What they receive |
|---|---|---|
| Nasal antimicrobial photodisinfection therapy (aPDT) | Experimental | Nasal antimicrobial photodisinfection therapy Receives: Combination Product: nasal antimicrobial photodisinfection therapy |
| Standard of Care Surgical Preventions - Control | No intervention | Standard of Care surgical site prevention measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with a Surgical Site Infection (SSI) within 30 days post surgery
Measured: Through 30 days post surgery
Percentage of Participants with Treatment-Related Adverse Events within 30 days after surgery.
Measured: Through 30 days post surgery
Secondary outcomes (3)
Mean hospital length of stay after surgery
Measured: From day of surgery (from 1 day up to 30 days)
Number of hospital readmissions within 30 days of surgery
Measured: From day of surgery through 30 days post surgery
Number of Participants with Staph aureus nasal colonization following aPDT (substudy)
Measured: Immediately following aPDT treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start27 Dec 2024
- Primary completion3 Apr 2026
- Study completion7 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model 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.
- Masking
- None (open label)
- Enrolment
- 4,787 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondine Biomedical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Simon Sinclair, MD, PhD, Study director, Ondine Biomedical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702878
- Sponsor's protocol ID
- OBI-NPDT-SSI-004
- Acronym
- LANTERN
- Status last verified
- Sep 2026
- First submitted
- 12 Nov 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Group-Randomized, Standard-of-Care-Controlled, Crossover Trial Evaluating Nasal Antimicrobial Photodisinfection for the Prevention of Surgical Site Infections
- ClinicalTrials.gov ID
- NCT06702878
- Acronym / sponsor ID
- LANTERN / OBI-NPDT-SSI-004
- Keywords
- Surgical site infection, nasal decolonization, photodisinfection, nasal photodisinfection, Staphylococcus aureus, Photodynamic therapy, Methylene Blue, chlorhexidine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,787 participants (actual)
- Lead sponsor
- Ondine Biomedical Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Dec 2024 (actual)
- Primary completion
- 3 Apr 2026 (actual)
- Study completion
- 7 May 2026 (actual)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- compare the efficacy, and
- 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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model 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.
| Arm | Type | Receives |
|---|---|---|
| Nasal antimicrobial photodisinfection therapy (aPDT) | Experimental | Combination Product: nasal antimicrobial photodisinfection therapyNasal antimicrobial photodisinfection therapy |
| Standard of Care Surgical Preventions - Control | No intervention | –Standard of Care surgical site prevention measures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Surgical patients, willing to sign the informed consent form and participate in the study.
- ≥ 18 years of age
- 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:
- Are able to follow instructions, comply with protocol requirements, and participate in all required study visits.
Key exclusion criteria (10 listed)
- 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.
- Surgical indication of infection.
- History of surgery within 90 days prior to enrollment.
- Anticipated surgery other than the index surgical procedure prior to patient's completion of the study.
- Use of other nasal decolonization procedures on the day of surgery prior to the index procedure (mupirocin, povidone iodine, alcohol, etc.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nasal antimicrobial photodisinfection therapyApplication of NF-031 solution (methylene blue 0.01% USP (methylthioninium chloride) and 0.25% chlorhexidine gluconate) in the nares followed by 2-minutes of light with nasal illuminators. The application is repeated a second time for total treatment time of 5-minutes. | Combination product | Nasal antimicrobial photodisinfection therapy (aPDT) |
Primary outcome
Number of Participants with a Surgical Site Infection (SSI) within 30 days post surgery
Time frame: Through 30 days post surgery
Percentage of Participants with Treatment-Related Adverse Events within 30 days after surgery.
Time frame: Through 30 days post surgery
3 secondary outcomes
Mean hospital length of stay after surgery
Time frame: From day of surgery (from 1 day up to 30 days)
Number of hospital readmissions within 30 days of surgery
Time frame: From day of surgery through 30 days post surgery
Number of Participants with Staph aureus nasal colonization following aPDT (substudy)
Time frame: Immediately following aPDT treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Sinclair, MD, PhD study director
Ondine Biomedical
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing nasal antimicrobial photodisinfection therapy in people with Surgical Site Infections and Surgical Wound Infection, run by Ondine Biomedical Inc. at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with a Surgical Site Infection (SSI) within 30 days post surgery (time frame: Through 30 days post surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.