Using skin grafts to help heal radiation wounds

Using Autologous Epidermal Skin Micrografts to Improve Healing In Radiation Wounds: A Pilot Study

This study is testing if using skin grafts from a patient's own body can help heal skin wounds caused by radiation therapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 34 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Massachusetts General Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT04560803 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of epidermal grafting using the CelluTome Epidermal Harvesting System for patients suffering from radiation dermatitis. Participants will receive grafts from their own skin to treat radiation-induced wounds, with untreated areas serving as controls. The study involves a series of follow-up visits where wound healing will be assessed through photographs and questionnaires. The goal is to determine if this method can improve healing outcomes for patients with radiation-related skin injuries.

Who should consider this trial

Good fit: Ideal candidates are patients who have developed radiation-induced wounds following cancer treatment and have suitable areas for grafting.

Not a fit: Patients with active tanning or those whose wounds do not meet the study's criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance healing for patients suffering from radiation dermatitis.

How similar studies have performed: Previous studies have shown that epidermal grafting is effective for various types of wounds, but its application for radiation injuries is novel.

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.

Where this trial is running

Boston, Massachusetts

• Massachusetts General Hospital, Wellman Center for Photomedicine — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Yen-Lin E Chen, MD — Massachusetts General Hospital
• Study coordinator: Katie Vogel

Conditions Radiation Dermatitis; Epidermal graft; Skin graft; Radiation wound