Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections (NCT06702878) | Clinical Trial Compass
CompletedPhase 3
Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections
United States4,787 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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used light-activated antimicrobial therapy to prevent surgical site infections — how does that approach actually work, and is it something that could be considered for my upcoming surgery?
2Since this was a Phase 3 trial that has already completed, has the results data been published yet, and what did it show about how many patients developed infections compared to those who didn't receive the treatment?
3The trial tracked treatment-related adverse events over 30 days — what kinds of side effects or risks were observed with this light-activated therapy that I should weigh against the standard infection-prevention methods already used during surgery?
4How does this light-activated approach compare to the standard antiseptic or antibiotic protocols your surgical team already uses to prevent wound infections — is there a reason to consider one over the other for my situation?
5Given that this trial is now completed, is this therapy available outside of a clinical trial setting, or would I need to look for another study to access it?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.
. 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.
. Inability to tolerate insertion of the nasal light illuminator due to nasal obstructions or nares size, shape, or anatomical variants.