Epidermal Skin Grafts to Improve Healing In Radiation Wounds

ConditionRadiation Dermatitis

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

CelluTomeTM Epidermal Harvesting System
Device
Autologous epidermal grafts that will be placed at the treatment site

Treatment groups

34 Participants

are divided into 2 treatment groups

Group A: Epidermal GraftingExperimental treatment 1 intervention

Group B: No treatmentNo intervention 0 interventions

Trial outcomes

Primary outcomes

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

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Collaborator

Source ClinicalTrials.gov

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