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RECRUITING
NCT06702878
PHASE3

Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections

Sponsor: Ondine Biomedical Inc.

View on ClinicalTrials.gov

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

COMBINATION_PRODUCT

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