NCT06702878

Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections

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: Phase 3
• Study type: Interventional
• Enrollment: 4,514 (estimated)
• Sponsor: Ondine Biomedical Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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. After an approximate 6-week inactive interval period, each site will crossover to enroll the alternate group, up to a number of patients that matches the site's first period (or up to 10% more). 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. Nasal Microbiota Substudy Approximately 500 study patients will have pre-treatment and post-treatment nasal swabs (in the treatment group) or single pre-surgical nasal swabs (in the control group) collected and stored. These samples will be processed for quantitative microbiological evaluation of S. aureus.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-12-27
• Primary completion: 2026-04-03
• Completion: 2026-05-03
• First posted: 2024-11-25
• Last updated: 2026-04-13

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study