NCT04560803

Epidermal Skin Grafts to Improve Healing In Radiation Wounds

Using Autologous Epidermal Skin Micrografts to Improve Healing In Radiation Wounds: A Pilot Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Patients participating in this study will undergo the epidermal grafting procedure to a part of their radiation-induced wound. The remaining untreated area will serve as an irradiated control. The donor tissue will be collected from normal skin in the upper thigh area. In addition to their primary screening visit, patients will be followed up closely in a series of 9 study visits. During these sessions, photographs will be taken and patients will be asked to fill out questionnaires.

Conditions

• Radiation Dermatitis

Interventions

Type	Name	Description
DEVICE	CelluTomeTM Epidermal Harvesting System	Autologous epidermal grafts that will be placed at the treatment site

Timeline

• Start date: 2021-01-19
• Primary completion: 2028-03-01
• Completion: 2028-12-01
• First posted: 2020-09-23
• Last updated: 2023-10-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study