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
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
Treatments tested in this trial
- CelluTomeTM Epidermal Harvesting System
Treatment groups
34 Participants
are divided into 2 treatment groupsSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
3M
Collaborator
Source ClinicalTrials.gov