Epidermal Skin Grafts to Improve Healing In Radiation Wounds

NCT04560803 | Recruiting FDA Device

• 1 other identifier: 2019P001728
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Keywords

Epidermal graft; Skin graft; Radiation wound

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Epidermal Grafting

EXPERIMENTAL

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

Device: CelluTomeTM Epidermal Harvesting System

No treatment

NO INTERVENTION

This irradiated area will not receive any treatment

Interventions

CelluTomeTM Epidermal Harvesting System DEVICE

Autologous epidermal grafts that will be placed at the treatment site

Epidermal Grafting

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• 3M: collaborator

Study Sites (1)

Massachusetts General Hospital, Wellman Center for Photomedicine

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Radiodermatitis

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Study Officials

• Yen-Lin E Chen, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katie Vogel

CONTACT

6177242168; kevogel@mgh.harvard.edu

Elizabeth Morehouse

CONTACT

6177242168; emorehouse@partners.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 23, 2020
• Study Start: January 19, 2021
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

US (1)