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.
Surgical Site Infections, Surgical Wound Infection, Infections, Anti-Infective Agents
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.
Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections
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Centennial Medical Center, Nashville, Tennessee, United States, 37203
Medical City Frisco Hospital, Frisco, Texas, United States, 75034
Medical City Plano, Plano, Texas, United States, 75075
Methodist Main Hospital, San Antonio, Texas, United States, 78229
Methodist Stone Oak, San Antonio, Texas, United States, 78258
Johnston Willis Hospital, Richmond, Virginia, United States, 23235
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
18 Years to
ALL
No
Ondine Biomedical Inc.,
Simon Sinclair, MD, PhD, STUDY_DIRECTOR, Ondine Biomedical
2025-08