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NCT04560803 · ClinicalTrials.gov registry record · NA
Epidermal Skin Grafts to Improve Healing In Radiation Wounds
A NA study of Radiation Dermatitis, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT04560803: Recruiting NA study of Radiation Dermatitis, sponsored by Massachusetts General Hospital.
NCT04560803 is a NA study of Radiation Dermatitis that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 34 participants, below the 44-participant average among 5 other Radiation Dermatitis trials with a reported enrollment target (23% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04560803, a NA study of Radiation Dermatitis, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DEVICE CelluTomeTM Epidermal Harvesting System
Study Locations (1)
Massachusetts
- Massachusetts General Hospital, Wellman Center for Photomedicine - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2021-01-19 |
| Est. Completion | 2028-12 |
| Phase | NA |
What NCT04560803 shows while recruiting
NCT04560803 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 44-participant average among 5 other Radiation Dermatitis trials with a reported enrollment target (23% lower).
The record links to 1 condition, with Radiation Dermatitis appearing as the primary indexed condition, and to 1 intervention - of which CelluTomeTM Epidermal Harvesting System is the first listed.
NCT04560803 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04560803 about?
NCT04560803 is a clinical study titled "Epidermal Skin Grafts to Improve Healing In Radiation Wounds". 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 debride...
What is the current status of trial NCT04560803?
This trial is currently recruiting. It is a NA study. The enrollment target is 34 participants. The study started on 2021-01-19. Estimated completion is 2028-12.
What conditions does trial NCT04560803 study?
This clinical trial studies the following conditions: Radiation Dermatitis.
What interventions are being tested in trial NCT04560803?
The interventions under investigation include: CelluTomeTM Epidermal Harvesting System (DEVICE).
Who is sponsoring clinical trial NCT04560803?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04560803 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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