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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07489560
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older
* One or more thermal burns classified as either superficial partial thickness or deep partial thickness.
* Total Body Surface Area (TBSA) involvement between 5% and 15%.
* Total burn index wound area is greater than 25 cm 2 and less than 0.25 m 2 (2500 cm 2 )
* 1 If 2 or more burns are present, each must have an area greater than 15 cm 2
* The participant must be willing and able to participate in the informed consent process.
Exclusion Criteria:
* Full thickness burns.
* Burns present for \>72 hours prior to study evaluation
* Burns requiring immediate autografting.
* Superficial burns (1 st -degree) or burns not meeting criteria to be included in TBSA calculations.
* Chemical or electrical burns.
* Burns secondary to blast injury.
* Burns causing vascular or respiratory compromise and burns requiring escharotomy
* Any severe systemic comorbidities which could impair healing (e.g. active sepsis or major organ failure).
* Known coagulopathy, platelet disorder, INR \> 1.6, PTT \> 38s, or platelets \< 50,000 per mm 3
* Uncontrolled diabetes.
* Known life expectancy of \< 6 months.
* Evidence of active infection in burn.
* Target area for treatment includes the head, neck, palms of hands, soles of the feet, or genitals.
* Viral infection which could impair healing or immune function (e.g. HIV, HBV, HCV)
* Participants of childbearing potential who are pregnant, considering becoming pregnant within the next 6 months, and/or are unwilling to utilize an appropriate form of contraception.
* Currently requiring dialysis or planning to start within 6 months.
* Medical or psychological condition that, in the opinion of the investigator, may interfere with study assessments.
* Treated with hyperbaric oxygen therapy or a skin substitute within the 30 days prior to screening visit.
* Sensitivity to ofloxacin, vancomycin, or amphotericin antibiotics.
* Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07489560
Study Brief:
Protocol Section:
NCT07489560