Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections

NCT06702878 | Active Not Recruiting Phase 3 DMC FDA Drug FDA Device

• 1 other identifier: OBI-NPDT-SSI-004
• Study Type: interventional
• Target: 4,514
• Locations: 1 country
• Sites: 14

Brief 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. 1.compare the efficacy, and
2. 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).

Conditions

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

Keywords

Surgical site infection; nasal decolonization; photodisinfection; nasal photodisinfection; Staphylococcus aureus; Photodynamic therapy; Methylene Blue; chlorhexidine; Disinfection

Outcome Measures

Primary Outcomes (2)

• Number of Participants with a Surgical Site Infection (SSI) within 30 days post surgery

  Through 30 days post surgery

• Percentage of Participants with Treatment-Related Adverse Events within 30 days after surgery.

  Through 30 days post surgery

Secondary Outcomes (3)

• Mean hospital length of stay after surgery

  From day of surgery (from 1 day up to 30 days)

• Number of hospital readmissions within 30 days of surgery

  From day of surgery through 30 days post surgery

• Number of Participants with Staph aureus nasal colonization following aPDT (substudy)

  Immediately following aPDT treatment

Study Arms (2)

Nasal antimicrobial photodisinfection therapy (aPDT)

EXPERIMENTAL

Nasal antimicrobial photodisinfection therapy

Combination Product: nasal antimicrobial photodisinfection therapy

Standard of Care Surgical Preventions - Control

NO INTERVENTION

Standard of Care surgical site prevention measures

Interventions

nasal antimicrobial photodisinfection therapy COMBINATION_PRODUCT

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.

Nasal antimicrobial photodisinfection therapy (aPDT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Surgical patients, willing to sign the informed consent form and participate in the study.
• ≥ 18 years of age
• Presenting to an acute care hospital for major elective, urgent, or emergency surgery, defined as an open procedure involving a significant skin incision, including but not limited to the following types:
• Cardiac
• Vascular
• Orthopedic, including spine and 'clean' trauma
• Neurosurgery
• Breast surgeries
• Are able to follow instructions, comply with protocol requirements, and participate in all required study visits.

You may not qualify if:

• Pregnancy (current) or currently lactating. If patient is unsure of pregnancy status, a negative urine or serum pregnancy test (sensitive to 25 IU hCG) should be obtained within 14 days prior to surgery.
• Surgical indication of infection.
• History of surgery within 90 days prior to enrollment.
• Anticipated surgery other than the index surgical procedure prior to patient's completion of the study.
• Use of other nasal decolonization procedures on the day of surgery prior to the index procedure (mupirocin, povidone iodine, alcohol, etc.).
• Patient has any medical, social or psychiatric condition(s) or current substance abuse condition that, in the opinion of the investigator, would preclude the patient's ability to provide informed consent, or to comply with the study requirements.
• Enrollment in concomitant investigational research study in the past 30 days.
• Inability to tolerate insertion of the nasal light illuminator due to nasal obstructions or nares size, shape, or anatomical variants.
• Known allergic reactions to components of the nasal disinfection treatment including methylene blue or chlorhexidine gluconate.

Sponsors & Collaborators

• Ondine Biomedical Inc.: lead

Study Sites (14)

Swedish Medical Center

Englewood, Colorado, 80113, United States

Location

HCA Brandon Florida

Brandon, Florida, 33511, United States

Location

HCA Florida Largo Hospital

Largo, Florida, 33770, United States

Location

HCA Florida NorthSide Hospital

St. Petersburg, Florida, 33709, United States

Location

HCA Florida Trinity Hospital

Trinity, Florida, 34655, United States

Location

Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Medical City Frisco Hospital

Frisco, Texas, 75034, United States

Location

HCA Houston Healthcare Kingwood

Kingwood, Texas, 77339, United States

Location

Medical City Plano

Plano, Texas, 75075, United States

Location

Methodist Metropolitan Hospital

San Antonio, Texas, 78212, United States

Location

Methodist Main Hospital and Landmark

San Antonio, Texas, 78229, United States

Location

Methodist Stone Oak

San Antonio, Texas, 78258, United States

Location

HCA Houston Healthcare Clear Lake Hospital

Webster, Texas, 77598, United States

Location

Johnston Willis Hospital

Richmond, Virginia, 23235, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection; Infections; Staphylococcal Infections

Condition Hierarchy (Ancestors)

Wound Infection; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Simon Sinclair, MD, PhD

  Ondine Biomedical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 25, 2024
• Study Start: December 27, 2024
• Primary Completion: April 3, 2026
• Study Completion: May 3, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)