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RECRUITING
NCT07189858
NA

Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections - Canada

Sponsor: Ondine Biomedical Inc.

View on ClinicalTrials.gov

Summary

This is a Phase 4 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

4740

Start Date

2026-01-13

Completion Date

2026-04-30

Last Updated

2026-03-05

Healthy Volunteers

No

Interventions

DEVICE

Nasal antimicrobial photodisinfection therapy

The Steriwave Nasal Photodisinfection System is applied using a photosensitizer in the nose followed by 2-minutes of light with nasal illuminators. The application is repeated a second time for total treatment time of 5-minutes.

Locations (4)

Foothills Medical Centre

Calgary, Alberta, Canada

Rockyview General Hospital

Calgary, Alberta, Canada

University of Alberta Hospital

Edmonton, Alberta, Canada

Royal Columbian Hospital

New Westminster, British Columbia, Canada