Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections

Description

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

Study Overview

Study Details

Study overview

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.

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

Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections

Condition
Surgical Site Infections
Intervention / Treatment

-

Contacts and Locations

Nashville

Centennial Medical Center, Nashville, Tennessee, United States, 37203

Frisco

Medical City Frisco Hospital, Frisco, Texas, United States, 75034

Plano

Medical City Plano, Plano, Texas, United States, 75075

San Antonio

Methodist Main Hospital, San Antonio, Texas, United States, 78229

San Antonio

Methodist Stone Oak, San Antonio, Texas, United States, 78258

Richmond

Johnston Willis Hospital, Richmond, Virginia, United States, 23235

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Surgical patients, willing to sign the informed consent form and participate in the study.
  • 2. ≥ 18 years of age
  • 3. Presenting to an acute care hospital for major elective, urgent, or emergency surgery, defined as an open procedure involving a significant skin incision, including the following types:
  • 1. Cardiac
  • 2. Vascular
  • 3. Orthopedic, including spine and 'clean' trauma
  • 4. Neurosurgery
  • 5. Radical breast surgeries (radical mastectomy with or without reconstruction)
  • 4. Are able to follow instructions, comply with protocol requirements, and participate in all required study visits.
  • 1. 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.
  • 2. Surgical indication of infection.
  • 3. History of surgery within 30 days prior to enrollment.
  • 4. Anticipated surgery other than the index surgical procedure prior to patient's completion of the study.
  • 5. 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.
  • 6. Enrollment in concomitant investigational research study in the past 30 days.
  • 7. Inability to tolerate insertion of the nasal light illuminator due to nasal obstructions or nares size, shape, or anatomical variants.
  • 8. Known allergic reactions to components of the nasal disinfection treatment including methylene blue or chlorhexidine gluconate.
  • 9. Use of other nasal decolonization procedures prior to surgery (mupirocin, povidone iodine, alcohol other).

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ondine Biomedical Inc.,

Simon Sinclair, MD, PhD, STUDY_DIRECTOR, Ondine Biomedical

Study Record Dates

2025-08