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Procedure

Epidermal Skin Grafts for Radiation Skin Damage

N/A
Recruiting
Led By Yen-Lin E Chen, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Having suitable areas of treatment: All wounds in the area of interest must be at least 20 cm2 (~10 cm2 per treatment/control area)
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
Must not have
Active Herpes Simplex or Zoster at the time of treatment or having experienced more than three episodes of Herpes Simplex / Zoster eruption within a year of study enrollment
History of collagen vascular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will help determine if epidermal grafts can be an effective treatment option for radiation dermatitis.

Who is the study for?
This trial is for individuals who have skin wounds from radiation treatment, such as moist desquamation or superficial ulcers. Participants must have a wound area of at least 20 cm2 and be able to follow the study's schedule. They should not be part of another drug study, pregnant, have uncontrolled diabetes, or conditions that could interfere with healing.
What is being tested?
The trial tests the CelluTome Epidermal Grafting System on patients with radiation dermatitis. It evaluates if epidermal grafts harvested using this device can effectively heal radiation-induced skin injuries compared to traditional methods.
What are the potential side effects?
Potential side effects may include discomfort during the procedure, reactions at the donor or recipient site like redness or swelling, and possible infection risks. However, since there are no new drugs involved in this process, drug-related side effects are not expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My treatment area is large enough for the study.
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I have a wound caused by radiation treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had active herpes or more than three outbreaks in the past year.
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I have a history of collagen vascular disease.
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I have a history of immune system problems or take medication that weakens my immune system.
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My wound is on my face, hand, or foot.
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My wound shows signs of infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in the CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events v5) grading

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Epidermal GraftingExperimental Treatment1 Intervention
This irradiated area of the skin will be treated with autologous epidermal grafts
Group II: No treatmentActive Control1 Intervention
This irradiated area will not receive any treatment

Find a Location

Who is running the clinical trial?

3MIndustry Sponsor
158 Previous Clinical Trials
31,450 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
3,010 Previous Clinical Trials
13,308,973 Total Patients Enrolled
Yen-Lin E Chen, MDPrincipal InvestigatorMassachusetts General Hospital

Media Library

CelluTome Epidermal Harvesting System (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04560803 — N/A
Radiation Burn Research Study Groups: No treatment, Epidermal Grafting
Radiation Burn Clinical Trial 2023: CelluTome Epidermal Harvesting System Highlights & Side Effects. Trial Name: NCT04560803 — N/A
CelluTome Epidermal Harvesting System (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04560803 — N/A
~16 spots leftby Mar 2028
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