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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT05462860
Eligibility Criteria:
Inclusion Criteria:
* Male or Female ≥18 years and ≤75 years
* Acute partial thickness burns by friction, contact, scalding from hot liquids and flame
* TBSA total ≥2 %; burn treatment region of interest: all areas with partial-thickness burns excluding face, neck, scalp, and feet
* TBSA 3rd ≤5 % (not to be included as burn treatment region of interest)
* Subject is able and willing to sign Informed Consent or via legally authorized representative
Exclusion Criteria:
* Study Wound due to electrical, radioactive, or frostbite-related injury
* Infection of wounds in the study area at admission per Investigator or treating physician discretion
* Pregnancy/lactation
* Subjects who are unable to follow the protocol or who are likely to be non-compliant
* Participation in an active treatment arm of a burn wound related interventional study within 90 days of Screening Visit or during the study
* Prisoners
* Life expectancy less than 6 months
* Subjects who are receiving steroids, chronic anticoagulants, or immune suppressive treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05462860
Study Brief:
Protocol Section:
NCT05462860