RECRUITING

Epidermal Skin Grafts to Improve Healing In Radiation Wounds

Talk to us

Conditions

Radiation DermatitisEpidermal graftSkin graftRadiation wound

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-01-19
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04560803

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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;
  2. * Having suitable areas of treatment: All wounds in the area of interest must be at least 20 cm2 (\~10 cm2 per treatment/control area);
  3. * 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;
  4. * Able and willing to comply with all visit, treatment and evaluation schedules and requirements;
  5. * Wound considered appropriate by physician to receive epidermal grafting;
  6. * Able to understand and provide written informed consent;
  1. * Active tanning, including the use of tanning booths, during the course of the study;
  2. * Study wound exhibits clinical signs and symptoms of infection at the screening/enrollment visit;
  3. * Patient unable to provide donor site for epidermal harvesting;
  4. * Wound sites located on the face, hands or feet
  5. * 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;
  6. * History of collagen vascular disease;
  7. * 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;
  8. * History of immunosuppression/immune deficiency disorders (including human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) or use of immunosuppressive medications;
  9. * 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);
  10. * Mentally incompetent, prisoner or evidence of active substance or alcohol abuse;
  11. * 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;
  12. * Participation in another interventional study with potential exposure to an investigational drug within past 30 days;
  13. * Pregnant females, due to possible discomfort with the procedure even though the procedure is localized and there is no new drug.

Contacts and Locations

Study Contact

Katie Vogel
CONTACT
6177242168
kevogel@mgh.harvard.edu
Elizabeth Morehouse
CONTACT
6177242168
emorehouse@partners.org

Principal Investigator

Yen-Lin E Chen, MD
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital, Wellman Center for Photomedicine
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Yen-Lin E Chen, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-19
Study Completion Date2028-12

Study Record Updates

Study Start Date2021-01-19
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • Epidermal graft
  • Skin graft
  • Radiation wound

Additional Relevant MeSH Terms

  • Radiation Dermatitis