Recruiting

Epidermal Skin Grafts

Sponsor:

Massachusetts General Hospital

Code:

NCT04560803

Conditions

Radiation Dermatitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

CelluTomeTM Epidermal Harvesting System

Study Details

Brief summary:

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.

Conditions

Radiation Dermatitis

Study ID

NCT04560803

Start date

Jan 19, 2021

Status verified date

Oct, 2023

Completion date

Dec, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Epidermal Grafting

This irradiated area of the skin will be treated with autologous epidermal grafts

no intervention: No treatment

This irradiated area will not receive any treatment

Interventions

CelluTomeTM Epidermal Harvesting System

Autologous epidermal grafts that will be placed at the treatment site

Primary outcome measure

  • Change in the CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events v5) grading [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Katie Vogel

6177242168kevogel@mgh.harvard.edu

Elizabeth Morehouse

6177242168emorehouse@partners.org

Locations

Massachusetts General Hospital, Wellman Center for Photomedicine

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Katie Vogel

617-724-2168kevogel@mgh.harvard.edu

Elizabeth Morehouse

6177242168emorehouse@partners.org

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 23, 2023

Last verified

Oct, 2023

Keywords

  • Epidermal graft
  • Skin graft
  • Radiation wound

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2023-10-23.