Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections
Completed · Phase 3
Conditions studied: Surgical Site Infections, Surgical Wound Infection, Infections, Anti-Infective Agents
In brief
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.
Key facts
- Study ID
- NCT06702878
- Run by
- Ondine Biomedical Inc.
- People needed
- 4787
- Starts
- 2024-12-27
- Expected to finish
- 2026-05-07
- Last updated by the study team
- 2026-05-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Neurosurgery
- Breast surgeries
- Are able to follow instructions, comply with protocol requirements, and participate in all required study visits.
You may not qualify if…
- 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.
- 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.
Where it is running
- Swedish Medical Center — Englewood, Colorado, United States
- HCA Brandon Florida — Brandon, Florida, United States
- HCA Florida Largo Hospital — Largo, Florida, United States
- HCA Florida NorthSide Hospital — St. Petersburg, Florida, United States
- HCA Florida Trinity Hospital — Trinity, Florida, United States
- Centennial Medical Center — Nashville, Tennessee, United States
- Medical City Frisco Hospital — Frisco, Texas, United States
- HCA Houston Healthcare Kingwood — Kingwood, Texas, United States
- Medical City Plano — Plano, Texas, United States
- Methodist Metropolitan Hospital — San Antonio, Texas, United States
- Methodist Main Hospital and Landmark — San Antonio, Texas, United States
- Methodist Stone Oak — San Antonio, Texas, United States
- HCA Houston Healthcare Clear Lake Hospital — Webster, Texas, United States
- Johnston Willis Hospital — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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