Actively Recruiting
Epidermal Skin Grafts to Improve Healing In Radiation Wounds
Led by Massachusetts General Hospital · Updated on 2023-10-23
34
Participants Needed
1
Research Sites
410 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
3
3M
Collaborating Sponsor
AI-Summary
What this Trial 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. 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
Official Title
Epidermal Skin Grafts to Improve Healing In Radiation Wounds
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Status post radiation treatment with radiation-induced wound including moist desquamation, full epidermal necrosis, or superficial dermal ulcerations
- Wounds must be at least 20 cm2 with about 10 cm2 for treatment and control areas
- Presence of a suitable adjacent irradiated control site confirmed by wound measurements
- Able and willing to comply with all visits, treatments, and evaluations
- Wound deemed appropriate by physician for epidermal grafting
- Able to understand and provide written informed consent
You will not qualify if you...
- Active tanning or use of tanning booths during the study
- Signs of infection at the wound site at screening/enrollment
- Unable to provide donor site for epidermal harvesting
- Wounds located on face, hands, or feet
- Adverse reactions to external agents required for study with no alternatives
- History of collagen vascular disease
- Active Herpes Simplex or Zoster or more than three episodes within past year
- History of immunosuppression or immune deficiency including HIV/AIDS or use of immunosuppressive drugs
- Significant illnesses interfering with anesthesia, treatment, or healing such as uncontrolled diabetes (HbA1C >8)
- Mentally incompetent, prisoner, or active substance/alcohol abuse
- Any condition making treatment unsafe as judged by Investigator
- Participation in another interventional study with investigational drug exposure within past 30 days
- Pregnancy due to possible discomfort from the procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital, Wellman Center for Photomedicine
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
K
Katie Vogel
CONTACT
E
Elizabeth Morehouse
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here