Status:
NOT_YET_RECRUITING
Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections - Canada
Lead Sponsor:
Ondine Biomedical Inc.
Conditions:
Surgical Site Infections
Infections
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a Phase 4 multi-center, group-randomized, crossover trial to compare nasal antimicrobial photodisinfection therapy (aPDT) with standard of care for prevention of surgical site infections in pa...
Detailed Description
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. Each hospital ('site') engage...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Exclusion Criteria Specific to Treatment Group Patients Only:
- 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.
Key Trial Info
Start Date :
November 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
4740 Patients enrolled
Trial Details
Trial ID
NCT07189858
Start Date
November 23 2025
End Date
December 31 2025
Last Update
November 17 2025
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