Radiation DermatitisNCT04560803
Epidermal Skin Grafts to Improve Healing In Radiation Wounds
A study testing CelluTomeTM Epidermal Harvesting System in people with Radiation Dermatitis, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Radiation Dermatitis
- What is being tested?
- CelluTomeTM Epidermal Harvesting System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2021to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- Having suitable areas of treatment: All wounds in the area of interest must be at least 20 cm2 (~10 cm2 per treatment/control area);
- The radiation injury must have a suitable adjacent irradiated control site before initiation of treatment. This will be determined by objective measurements of % wound epithelization, wound erythema, pliability, induration and thickness at enrollment;
- Able and willing to comply with all visit, treatment and evaluation schedules and requirements;
- Wound considered appropriate by physician to receive epidermal grafting;
- Able to understand and provide written informed consent;
Who cannot join
- Active tanning, including the use of tanning booths, during the course of the study;
- Study wound exhibits clinical signs and symptoms of infection at the screening/enrollment visit;
- Patient unable to provide donor site for epidermal harvesting;
- Wound sites located on the face, hands or feet
- Adverse reactions to compounds of any external agent (e.g., gels, lotions or anesthetic creams) required for use in the study, if no alternative to the said agent exists;
- History of collagen vascular disease;
Show all 13Show fewer
- 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 immunosuppression/immune deficiency disorders (including human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) or use of immunosuppressive medications;
- Significant concurrent illness, such as uncontrolled diabetes (with a hemoglobin A1C of more than 8) (i.e., any disease state that in the opinion of the Investigator would interfere with the anesthesia, treatment, or healing process);
- Mentally incompetent, prisoner or evidence of active substance or alcohol abuse;
- Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or study personnel) to treat the subject as part of this research study;
- Participation in another interventional study with potential exposure to an investigational drug within past 30 days;
- Pregnant females, due to possible discomfort with the procedure even though the procedure is localized and there is no new drug.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital, Wellman Center for Photomedicine
Boston, Massachusetts, 02114
Katie Vogel, 617-724-2168, kevogel@mgh.harvard.edu
Elizabeth Morehouse, 6177242168, emorehouse@partners.org
About this study
Official title: Using Autologous Epidermal Skin Micrografts to Improve Healing In Radiation Wounds: A Pilot Study
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.
Read more
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.
Read the 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
- Being tested
- CelluTomeTM Epidermal Harvesting System
- Keywords
- Epidermal graft, Skin graft, Radiation wound
- Medical subject headings
- Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelluTomeTM Epidermal Harvesting SystemDevice
Autologous epidermal grafts that will be placed at the treatment site
| Study group | Role | What they receive |
|---|---|---|
| Epidermal Grafting | Experimental | This irradiated area of the skin will be treated with autologous epidermal grafts Receives: Device: CelluTomeTM Epidermal Harvesting System |
| No treatment | No intervention | This irradiated area will not receive any treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events v5) grading
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start19 Jan 2021
- Primary completionMar 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation DermatitisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- 3M
- Responsible party
- Principal investigator, Thanh-Nga T. Tran, M.D.,Ph.D., Massachusetts General Hospital
- Investigators
- Yen-Lin E Chen, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560803
- Sponsor's protocol ID
- 2019P001728
- Status last verified
- Oct 2023
- First submitted
- 17 Sep 2020
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Autologous Epidermal Skin Micrografts to Improve Healing In Radiation Wounds: A Pilot Study
- ClinicalTrials.gov ID
- NCT04560803
- Acronym / sponsor ID
- 2019P001728
- Conditions
- Radiation Dermatitis
- Keywords
- Epidermal graft, Skin graft, Radiation wound
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- 3M
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidermal Grafting | Experimental | Device: CelluTomeTM Epidermal Harvesting SystemThis irradiated area of the skin will be treated with autologous epidermal grafts |
| No treatment | No intervention | –This irradiated area will not receive any treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
- Having suitable areas of treatment: All wounds in the area of interest must be at least 20 cm2 (~10 cm2 per treatment/control area);
- The radiation injury must have a suitable adjacent irradiated control site before initiation of treatment. This will be determined by objective measurements of % wound epithelization, wound erythema, pliability, induration and thickness at enrollment;
- Able and willing to comply with all visit, treatment and evaluation schedules and requirements;
- Wound considered appropriate by physician to receive epidermal grafting;
Key exclusion criteria (13 listed)
- Active tanning, including the use of tanning booths, during the course of the study;
- Study wound exhibits clinical signs and symptoms of infection at the screening/enrollment visit;
- Patient unable to provide donor site for epidermal harvesting;
- Wound sites located on the face, hands or feet
- Adverse reactions to compounds of any external agent (e.g., gels, lotions or anesthetic creams) required for use in the study, if no alternative to the said agent exists;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CelluTomeTM Epidermal Harvesting SystemAutologous epidermal grafts that will be placed at the treatment site | Device | Epidermal Grafting |
Primary outcome
Change in the CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events v5) grading
Time frame: 12 months
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yen-Lin E Chen, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CelluTomeTM Epidermal Harvesting System in people with Radiation Dermatitis, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katie Vogel (6177242168, kevogel@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events v5) grading (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.