Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT07189858
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 but not limited to the following types:
1. Cardiac
2. Vascular
3. Orthopedic, including spine and 'clean' trauma
4. Neurosurgery
5. Breast surgeries
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 90 days prior to enrollment.
4. Anticipated surgery other than the index surgical procedure prior to patient's completion of the study.
5. Use of other nasal decolonization procedures on the day of surgery prior to the index procedure (mupirocin, povidone iodine, alcohol, etc.).
6. 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.
7. Enrollment in concomitant investigational research study in the past 30 days.
Exclusion Criteria Specific to Treatment Group Patients Only:
8. Inability to tolerate insertion of the nasal light illuminator due to nasal obstructions or nares size, shape, or anatomical variants.
9. Known allergic reactions to components of the nasal disinfection treatment including methylene blue or chlorhexidine gluconate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07189858
Study Brief:
Protocol Section:
NCT07189858