Epidermal Skin Grafts to Improve Healing In Radiation Wounds

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

Patients undergoing radiation for the treatment of malignancies may suffer from side effects to the skin in the form of radiation dermatitis. This can lead to local wound formation with poor healing. Treatment options for the resulting wound can range from watchful waiting to more aggressive debridement and secondary grafting.

Epidermal grafting is a technique in which autologous epidermis is used to cover wounds that are larger than the donor site. Previous studies have demonstrated that this is an effective treatment for different wounds and ulcers but its utility has not yet been evaluated for the treatment of radiation induced injuries.

The CelluTome Epidermal Grafting System is a semi automated device that allows easy formation of epidermal Blister.

Our study will evaluate the efficacy of epidermal grafts collected using the CelluTome device in the treatment of radiation dermatitis.

Study Overview

• Status: Recruiting
• Conditions: Radiation Dermatitis
• Intervention / Treatment: Device: CelluTomeTM Epidermal Harvesting System

Detailed Description

Patients participating in this study will undergo the epidermal grafting procedure to a part of their radiation-induced wound. The remaining untreated area will serve as an irradiated control.

The donor tissue will be collected from normal skin in the upper thigh area. In addition to their primary screening visit, patients will be followed up closely in a series of 9 study visits. During these sessions, photographs will be taken and patients will be asked to fill out questionnaires.

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katie Vogel; Phone Number: 6177242168; Email: kevogel@mgh.harvard.edu
• Study Contact Backup: Name: Elizabeth Morehouse; Phone Number: 6177242168; Email: emorehouse@partners.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital, Wellman Center for Photomedicine
      • Contact: Elizabeth Morehouse; Phone Number: 6177242168; Email: emorehouse@partners.org
      • Contact: Katie Vogel; Phone Number: 617-724-2168; Email: kevogel@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Epidermal Grafting; This irradiated area of the skin will be treated with autologous epidermal grafts	Device: CelluTomeTM Epidermal Harvesting System; Autologous epidermal grafts that will be placed at the treatment site
No Intervention: No treatment; This irradiated area will not receive any treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events v5) grading	Patients will receive a grading for their treated radiation wound based on the CTCAE. Changes in the grading over time will be used to assess improvement of the wound	12 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: 3M
• Investigators: Principal Investigator: Yen-Lin E Chen, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2021
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: September 17, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Skin graft; Epidermal graft; Radiation wound
• Additional Relevant MeSH Terms: Skin Diseases; Wounds and Injuries; Radiation Injuries; Dermatitis; Radiodermatitis
• Other Study ID Numbers: 2019P001728

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes