Epidermal Skin Grafts to Improve Healing In Radiation Wounds

Inclusion Criteria:

• Status post radiation treatment, with radiation-induced wound. This includes patientwith moist desquamation as well as full epidermal necrosis and superficial dermalulcerations, 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 atleast 20 cm2 (~10 cm2 per treatment/control area);
• The radiation injury must have a suitable adjacent irradiated control site beforeinitiation of treatment. This will be determined by objective measurements of % woundepithelization, wound erythema, pliability, induration and thickness at enrollment;
• Able and willing to comply with all visit, treatment and evaluation schedules andrequirements;
• 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 thescreening/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 oranesthetic creams) required for use in the study, if no alternative to the said agentexists;
• History of collagen vascular disease;
• Active Herpes Simplex or Zoster at the time of treatment or having experienced morethan three episodes of Herpes Simplex / Zoster eruption within a year of studyenrollment;
• History of immunosuppression/immune deficiency disorders (including humanimmunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) oruse of immunosuppressive medications;
• Significant concurrent illness, such as uncontrolled diabetes (with a hemoglobin A1Cof more than 8) (i.e., any disease state that in the opinion of the Investigator wouldinterfere 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 thesubject or study personnel) to treat the subject as part of this research study;
• Participation in another interventional study with potential exposure to aninvestigational drug within past 30 days;
• Pregnant females, due to possible discomfort with the procedure even though theprocedure is localized and there is no new drug.