Epidermal Skin Grafts to Improve Healing In Radiation Wounds

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT04560803
Status
Recruiting
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Conditions

  • Radiation Dermatitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • CelluTomeTM Epidermal Harvesting System — DEVICE
    Autologous epidermal grafts that will be placed at the treatment site

Study Details

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.

Key Dates

Start date
Jan 19, 2021
Status verified
Oct 2023
Primary completion
Mar 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
34 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General Hospital, Wellman Center for PhotomedicineBostonMassachusetts02114
Katie Vogel
[email protected]
617-724-2168
Elizabeth Morehouse
[email protected]
6177242168

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By research site
Massachusetts General Hospital, Wellman Center for Photomedicine· Boston, MA

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