Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections

Launched by ONDINE BIOMEDICAL INC. · Nov 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called nasal antimicrobial photodisinfection therapy (aPDT) to see if it can help prevent infections after surgery. Researchers want to find out how effective and safe this treatment is compared to the usual care given to patients before major surgeries. The trial will involve patients who are having significant surgeries, such as heart, vascular, orthopedic, or breast surgeries, and who are at least 18 years old.

If you decide to participate, you will either receive the new nasal treatment on the day of your surgery or continue with the standard infection prevention methods. To be eligible, you need to be planning for major surgery at a hospital and be willing to sign consent forms. However, if you are currently pregnant, have had surgery recently, or have certain medical conditions, you may not qualify for the study. This trial is currently recruiting participants, and it’s an opportunity to contribute to important research that could help improve surgical care for everyone.

Gender

ALL

Eligibility 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).