NCT07189858

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

A Group-Randomized, Standard-of-Care-Controlled, Crossover Trial Evaluating Nasal Antimicrobial Photodisinfection for the Prevention of Surgical Site Infections

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,740 (estimated)
• Sponsor: Ondine Biomedical Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study employs a group-randomized crossover design, comparing outcomes from the treatment group with that of a standard-of-care control group from the same hospitals. Each hospital ('site') engaged in the study will be randomly assigned to treatment plus standard-of-care or standard-of-care control on a 1:1 basis and will enroll patients into those respective groups during the first period of the study. Once 50% of the patients have been enrolled and approximately 100% of these have been through their 30-day visit (i.e., at the completion of period 1), an interim analysis will be performed to establish conditional power of the study and the sample size recalculated. In the event that the revised power calculation indicates that more patients are required to meet the primary endpoint, the enrollment period, number of sites, and site-level logistics may be adjusted to accommodate this additional enrollment. Eligible patients who successfully complete all screening assessments and meet inclusion and exclusion criteria will be enrolled. Patients in the treatment group will undergo aPDT treatment after admission to the preoperative area. All patients will be followed up for a 30-day post-surgery period. A patient-reported outcome (PRO) assessment to gauge the tolerability of the intervention after administration will also be performed in the treatment group. Standard-of-care infection control practices will be applied according to infection prevention policies and procedures in place at each hospital. These practices are to remain unchanged for both groups throughout the study. Microbiological samples will also be collected from any SSI and evaluated to establish the causative organism and its antibiotic susceptibility. The incidence of SSIs during the 30-day postoperative period will be tracked to ensure comprehensive follow-up evaluations. In-person unscheduled visits will be conducted for medical assessment of suspected SSIs and collection of wound cultures.

Conditions

• Surgical Site Infections
• Infections
• Surgical Wound Infections
• Anti-Infective Agents

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-13
• Primary completion: 2026-04-10
• Completion: 2026-05-10
• First posted: 2025-09-24
• Last updated: 2026-04-14

Locations

4 sites across 1 country: Canada