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Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections

NCT06702878 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4787

Last updated 2026-05-12

No results posted yet for this study

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.

Conditions

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

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.

Sponsors & Collaborators

  • Ondine Biomedical Inc.

    lead INDUSTRY

Principal Investigators

  • Simon Sinclair, MD, PhD · Ondine Biomedical

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-27
Primary Completion
2026-04-03
Completion
2026-05-07
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06702878 on ClinicalTrials.gov