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 @ 7:39 PM
Ignite Modification Date:
2025-12-24 @ 7:39 PM
NCT ID:
NCT04560803
Eligibility Criteria:
Inclusion Criteria:
* Status post radiation treatment, with radiation-induced wound. This includes patient with moist desquamation as well as full epidermal necrosis and superficial dermal ulcerations, this wound would otherwise be allowed to heal by secondary intention;
* Having suitable areas of treatment: All wounds in the area of interest must be at least 20 cm2 (\~10 cm2 per treatment/control area);
* The radiation injury must have a suitable adjacent irradiated control site before initiation of treatment. This will be determined by objective measurements of % wound epithelization, wound erythema, pliability, induration and thickness at enrollment;
* Able and willing to comply with all visit, treatment and evaluation schedules and requirements;
* Wound considered appropriate by physician to receive epidermal grafting;
* Able to understand and provide written informed consent;
Exclusion Criteria:
* Active tanning, including the use of tanning booths, during the course of the study;
* Study wound exhibits clinical signs and symptoms of infection at the screening/enrollment visit;
* Patient unable to provide donor site for epidermal harvesting;
* Wound sites located on the face, hands or feet
* Adverse reactions to compounds of any external agent (e.g., gels, lotions or anesthetic creams) required for use in the study, if no alternative to the said agent exists;
* History of collagen vascular disease;
* Active Herpes Simplex or Zoster at the time of treatment or having experienced more than three episodes of Herpes Simplex / Zoster eruption within a year of study enrollment;
* History of immunosuppression/immune deficiency disorders (including human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) or use of immunosuppressive medications;
* Significant concurrent illness, such as uncontrolled diabetes (with a hemoglobin A1C of more than 8) (i.e., any disease state that in the opinion of the Investigator would interfere with the anesthesia, treatment, or healing process);
* Mentally incompetent, prisoner or evidence of active substance or alcohol abuse;
* Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or study personnel) to treat the subject as part of this research study;
* Participation in another interventional study with potential exposure to an investigational drug within past 30 days;
* Pregnant females, due to possible discomfort with the procedure even though the procedure is localized and there is no new drug.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04560803
Study Brief:
Protocol Section:
NCT04560803