NCT04560803 · Massachusetts General Hospital
Epidermal Skin Grafts to Improve Healing In Radiation Wounds
What this study is about
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.
View original scientific 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.
Interventions
DEVICE
CelluTomeTM Epidermal Harvesting System
Autologous epidermal grafts that will be placed at the treatment site
Primary outcome measures
Change in the CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events v5) grading
Time frame: 12 months
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Boston, Massachusetts
Collaborators
3M
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 23, 2023 · Source of record for eligibility and locations