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 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT05517902
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent provided by the parent(s) or legal guardian(s) and assent from the child when appropriate
* Have enough healthy skin to reserve as donor site(s), in case autografting becomes necessary
* Thermal burns of no more than a total of 30% TBSA
* Study treatment sites that are DPT in depth and which are clinically indicated for excision and autografting, and located on the torso or extremities
* Study treatment area(s) totaling 0.5% to 10% TBSA and may be composed of up to 3 non-contiguous areas located on the same extremity or plane of the torso
* Sufficient healthy skin available and reserved as a donor site in the event that the StrataGraft treatment site requires autografting
Exclusion Criteria:
* Is pregnant or breastfeeding
* Receiving treatment to suppress the immune system and/or systemic corticosteroids (inhaled corticosteroids are permitted)
* A known history of malignancy
* Pre-admission insulin-dependent diabetes
* Concurrent trauma, conditions, and/or personal situations that, in the opinion of the investigator, may compromise the participant's safety or the study objectives
* A burn injury that occurred ≥ 14 days prior to planned StrataGraft application Is expected to survive less than 12 months
* Is participating in another interventional trial, or did within 90 days before enrollment
* A proposed study treatment site that has been previously excised or autografted; located adjacent to an undebrided/unexcised burn area; demonstrates signs and symptoms of wound infection, per judgement of the clinical investigator; lies across joints or is located on the feet (i.e., distal to the malleolus), hands (distal to the wrist), face, neck, buttocks, perineum, or genitalia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
17 Years
Study:
NCT05517902
Study Brief:
Protocol Section:
NCT05517902