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Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections
Sponsor: Ondine Biomedical Inc.
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.
Official title: A Group-Randomized, Standard-of-Care-Controlled, Crossover Trial Evaluating Nasal Antimicrobial Photodisinfection for the Prevention of Surgical Site Infections
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
4514
Start Date
2024-12-27
Completion Date
2026-04-30
Last Updated
2026-03-06
Healthy Volunteers
No
Interventions
nasal antimicrobial photodisinfection therapy
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.
Locations (14)
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