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Epidermal Skin Grafts to Improve Healing In Radiation Wounds
NCT04560803 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04560803
The ClinicalTrials.gov registry entry for NCT04560803 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 1,948 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04560803 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04560803?
The interventions under investigation include: CelluTomeTM Epidermal Harvesting System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04560803?
This trial is sponsored by Massachusetts General Hospital, which has 1,948 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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