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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)
Wound considered appropriate by physician to receive epidermal grafting
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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My doctor thinks my wound is suitable for skin grafting.
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My radiation injury has a comparable area nearby for treatment comparison.
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I have a wound caused by radiation treatment.

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

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

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
157 Previous Clinical Trials
31,310 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,924 Previous Clinical Trials
13,193,389 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 Skin Damage Research Study Groups: No treatment, Epidermal Grafting
Radiation Skin Damage 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age criterion for enrolment in this clinical trial above or below 20 years of age?

"To meet the set requirements for enrollment in this experiment, patients must be over 18 years old and below 80."

Answered by AI

Are there still open positions in this research project?

"Affirmative, the information on clinicaltrials.gov points to this medical trial being open for recruitment at present. This experiment was first posted and last updated on January 19th 2021, with a need of 34 participants from 1 centre."

Answered by AI

Is it possible for me to be a participant in this medical study?

"This research endeavour, which seeks to enrol 34 volunteers, requires that potential participants have dermatitis and fall within the ages of 18 and 80."

Answered by AI

What is the total number of participants that have been admitted to this research?

"Affirmative. Clinicaltrials.gov has the information that indicates this medical trial is actively signing up volunteers, commencing on January 19th 2021 and was most recently updated on the same date. 34 participants are being enrolled at a single site."

Answered by AI
~19 spots leftby Mar 2028