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 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT04765202
Eligibility Criteria:
Inclusion Criteria:
* Has 2% to 49% (inclusive) total body surface area (TBSA) thermal burn area, including areas of full thickness (FT) injury clinically indicated for surgical excision and autografting, appropriate for protocol-defined treatment areas
* Meets protocol-specified criteria for qualification and contraception
* Is willing and able to comply with all study procedures and requirements
* Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures
Exclusion Criteria:
* Is a prisoner, pregnant, or had previous autografting to treatment sites
* Is expected to survive less than 3 months
* Is participating in another interventional trial, or did within 30 days before enrollment
* Has anticipated treatment sites that are outside protocol-specified parameters
* Has concurrent clinically significant inhalation injury, inadequate fluid resuscitation, or burns of chemical or electrical (non-thermal) etiology
* Has other signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
1. The safety or well-being of the participant
2. The study objectives
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04765202
Study Brief:
Protocol Section:
NCT04765202