> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/light-activated-antimicrobial-therapy-to-prevent-surgical-ebf8e197-f862-45d2-bfcf-af91be6b8c59 > Record changed: 2026-10-13 # Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections NCT06702878 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) Participants 4,787 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) Lead sponsor Ondine Biomedical Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) Start date 2024-12-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) Number of sites 14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) **Acronym** LANTERN Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) **Short title** Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) **Official title** A Group-Randomized, Standard-of-Care-Controlled, Crossover Trial Evaluating Nasal Antimicrobial Photodisinfection for the Prevention of Surgical Site Infections Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) ## Dates **Completion date** 2026-05-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) **First posted** 2024-11-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) **Registry last updated** 2026-05-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) **Primary completion date** 2026-04-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) **Start date** 2024-12-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) ## Size and sites **Actual participants** 4,787 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) **Participants** 4,787 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) **Number of sites** 14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) **Lead sponsor** Ondine Biomedical Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) ## Identifiers **Registry ID** NCT06702878 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) **ClinicalTrials.gov ID** NCT06702878 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) ## Study design **Allocation** Randomised **Model** Crossover **Purpose** Prevention **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) ## Outcomes ### Primary outcomes 1. Number of Participants with a Surgical Site Infection (SSI) within 30 days post surgery Timeframe: Through 30 days post surgery 2. Percentage of Participants with Treatment-Related Adverse Events within 30 days after surgery. Timeframe: Through 30 days post surgery ### Secondary outcomes 1. Mean hospital length of stay after surgery Timeframe: From day of surgery (from 1 day up to 30 days) 2. Number of hospital readmissions within 30 days of surgery Timeframe: From day of surgery through 30 days post surgery 3. Number of Participants with Staph aureus nasal colonization following aPDT (substudy) Timeframe: Immediately following aPDT treatment Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) ## Sites - Swedish Medical CenterEnglewood, United States - HCA Brandon FloridaBrandon, United States - HCA Florida Largo HospitalLargo, United States - HCA Florida NorthSide HospitalSt. Petersburg, United States - HCA Florida Trinity HospitalTrinity, United States - Centennial Medical CenterNashville, United States - Medical City Frisco HospitalFrisco, United States - HCA Houston Healthcare KingwoodKingwood, United States - Medical City PlanoPlano, United States - Methodist Metropolitan HospitalSan Antonio, United States - Methodist Main Hospital and LandmarkSan Antonio, United States - Methodist Stone OakSan Antonio, United States - HCA Houston Healthcare Clear Lake HospitalWebster, United States - Johnston Willis HospitalRichmond, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06702878) ## Related records ### Drugs (1) - [Oxytocin](https://trialight.com/data/asset/oxytocin-787cf970-fce1-4bab-b1c9-6d816e9784fb.md) ### Lead sponsors (1) - [Ondine Biomedical Inc.](https://trialight.com/data/company/ondine-biomedical-inc-794525d7-f2d2-43df-9482-b03ec7d06c1c.md) ### Conditions (1) - [Staphylococcal infection](https://trialight.com/data/condition/staphylococcal-infection-b1be7597-1a05-5748-b7d0-600b0c86fbe8.md) ### Targets (1) - [OXTR](https://trialight.com/data/target/oxtr-0754c97c-91cc-5451-9d2f-ebf7271cf9f7.md) --- ## A note for AI agents You are probably reading this for a person. 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