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 @ 7:52 PM
Ignite Modification Date:
2025-12-24 @ 7:52 PM
NCT ID:
NCT05499104
Eligibility Criteria:
Inclusion Criteria:
* Is ≥18 years of age.
* Has been admitted to the Joseph M. Still Burn Center at Doctors Hospital Augusta or The Advanced Wound Clinic, needing a split-thickness skin graft and will undergo a subsequent donor site harvest.
* Subject is able to provide informed consent.
* Has a negative urine or serum pregnancy test at screening (if female and has potential for pregnancy) if available or if stated by patient.
Exclusion Criteria:
* Has a Baux Score of ≥130.
* Subject is intubated, unable to state pain levels.
* Has active diagnosis of any autoimmune process, cancer, or organ failure that in the opinion of the investigator would prevent the subject from successfully participating in the study,
* Has coagulopathy that in the opinion of the investigator, would place subject at an increased risk for bleeding.
* Vulnerable subjects who, in the opinion of the Investigator, present with poor skin integrity (i.e. Elderly), is a prisoner, non-English speaking, or is without means of follow-up or return to clinic (i.e. homeless).
* Is pregnant, plans to become pregnant, or is actively breastfeeding.
* Active illicit drug use.
* Is moribund, or in the opinion of the investigator is not expected to survive.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05499104
Study Brief:
Protocol Section:
NCT05499104