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:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-24 @ 12:47 PM
NCT ID:
NCT05167461
Eligibility Criteria:
Subjects must meet all the following enrollment criteria to be eligible for participation in the study:
1. Male or female patients aged 18 years and above.
2. The patient has a thermal burn injury
3. Antibiotic use allowed
4. Patient does not need to have the ability to communicate
5. Inpatient or outpatient
6. Within 7 days of burn
7. No prior surgical debridement
8. Burn ≤ 75% of body surface
9. The patient or their legal representative agrees to comply with all compulsory study procedures and visit schedule
10. The patient or their legal representative agrees to abstain from enrollment in any other clinical trial for the duration of the study.
11. In the opinion of the investigator, the patient or their legal representative must be able to:
1. Understand the full nature and purpose of the study, including possible risks and adverse events,
2. Understand instruction, and
3. Provide voluntary informed written consent/assent as appropriate for study participation.
Exclusion Criteria: Subjects who meet any of the following criteria are not eligible for participation in the study:
1. Unable to provide informed consent
2. Age \<18 years
3. Burn ≥ 75% of body surface
4. Burns caused by chemicals, electricity or radiation.
5. Patients presenting with only 3rd-degree/full-thickness wounds which require immediate autografting.
6. Burn injury has had prior surgical treatment.
7. Prisoners
8. Pregnant individuals
9. Unable to follow study schedule or understand study instructions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05167461
Study Brief:
Protocol Section:
NCT05167461