Light therapy to prevent infections after surgery
A Group-Randomized, Standard-of-Care-Controlled, Crossover Trial Evaluating Nasal Antimicrobial Photodisinfection for the Prevention of Surgical Site Infections
This study is testing if a special light therapy can help prevent infections after major surgeries compared to regular care.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 4514 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ondine Biomedical Inc. Industry-sponsored |
| Locations | 10 sites (Brandon, Florida and 9 other locations) |
| Trial ID | NCT06702878 on ClinicalTrials.gov |
What this trial studies
This Phase 3 clinical trial evaluates the effectiveness of nasal antimicrobial photodisinfection therapy (aPDT) compared to standard care in preventing surgical site infections (SSIs) in patients undergoing major surgeries. The study employs a group-randomized crossover design, where participating hospitals will alternate between administering aPDT and standard care to enrolled patients. Patients will be monitored for 30 days post-surgery to assess the incidence of SSIs and the tolerability of the treatment. Microbiological samples will also be collected to identify any infections and their antibiotic susceptibility.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older undergoing major elective, urgent, or emergency surgeries such as cardiac, vascular, orthopedic, neurosurgery, or radical breast surgeries.
Not a fit: Patients who are currently pregnant, lactating, or have a surgical indication of infection will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of surgical site infections, improving patient outcomes and recovery times.
How similar studies have performed: While the use of photodisinfection therapy is a novel approach, similar studies have shown promise in reducing infections, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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. Exclusion Criteria: 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. Exclusion Criteria Specific to Treatment Group Patients Only: 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. Exclusion Criteria Specific to the Nasal Microbiota Substudy Only: 9. Use of other nasal decolonization procedures prior to surgery (mupirocin, povidone iodine, alcohol other).
Where this trial is running
Brandon, Florida and 9 other locations
- HCA Brandon Florida — Brandon, Florida, United States (Recruiting)
- HCA Florida Largo Hospital — Largo, Florida, United States (Recruiting)
- HCA Florida NorthSide Hospital — St. Petersburg, Florida, United States (Recruiting)
- HCA Florida Trinity Hospital — Trinity, Florida, United States (Recruiting)
- Centennial Medical Center — Nashville, Tennessee, United States (Recruiting)
- Medical City Frisco Hospital — Frisco, Texas, United States (Recruiting)
- Medical City Plano — Plano, Texas, United States (Recruiting)
- Methodist Main Hospital — San Antonio, Texas, United States (Recruiting)
- Methodist Stone Oak — San Antonio, Texas, United States (Recruiting)
- Johnston Willis Hospital — Richmond, Virginia, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Simon Sinclair, MD, PhD
- Email: ssinclair@ondinebio.com
- Phone: 1-425-489-1100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.