Using skin grafts to help heal radiation wounds

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: kevogel@mgh.harvard.edu
• Phone: 6177242168

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Amino acid–derived antioxidant lipids to prevent and treat radiation skin damage in head and neck cancer

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• Skin-repair cream to prevent radiation dermatitis after breast cancer surgery

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• ROS-scavenging nanoenzyme prevention for radiation dermatitis in head and neck cancer

  This trial will try to see if giving novel ROS-scavenging nanoenzymes can prevent radiation-related skin damage in people receiving high-dose radiotherapy for head and neck cancer.

  Recruiting West China Hospital · Chengdu, Sichuan · NCT07064577

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.