Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections (NCT06702878) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections
United States4,514 participantsStarted 2024-12-27
Plain-language 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. 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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.
What they're measuring
1
Number of Participants with a Surgical Site Infection (SSI) within 30 days post surgery
Timeframe: Through 30 days post surgery
2
Percentage of Participants with Treatment-Related Adverse Events within 30 days after surgery.
. 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.