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New treatment option for Radiation Dermatitis
Official title Epidermal Skin Grafts to Improve Healing In Radiation Wounds
ClinicalTrials.gov ID: NCT04560803
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Status post radiation treatment, with radiation-induced wound. This includes patient with moist desquamation as well as full epidermal necrosis and...
- 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...
- Able and willing to comply with all visit, treatment and evaluation schedules and requirements;
- Wound considered appropriate by physician to receive epidermal grafting;
You likely can't join if
- 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...
- History of collagen vascular disease;
See the full eligibility criteria
- 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...
- 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...
- 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;
- 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;
- 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...
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.