Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04560803
Other study ID # 2019P001728
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 19, 2021
Est. completion date December 2028

Study information

Verified date October 2023
Source Massachusetts General Hospital
Contact Katie Vogel
Phone 6177242168
Email kevogel@mgh.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 34
Est. completion date December 2028
Est. primary completion date March 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion 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 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; Exclusion Criteria: - 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 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
CelluTomeTM Epidermal Harvesting System
Autologous epidermal grafts that will be placed at the treatment site

Locations

Country Name City State
United States Massachusetts General Hospital, Wellman Center for Photomedicine Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital 3M

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 12 months
See also
  Status Clinical Trial Phase
Completed NCT04059809 - Photobiomodulation for Breast Cancer Radiodermatitis Phase 2/Phase 3
Not yet recruiting NCT06040983 - Clinical Investigation on the Treatment of Radiation Induced Dermatitis With FR-101 Chest Dressing N/A
Withdrawn NCT05505214 - Topical Steroids & Bacterial Decolonization for Radiation Dermatitis Phase 2
Withdrawn NCT04593914 - A Novel Skin Barrier Protectant for Acute Radiodermatitis N/A
Completed NCT05450848 - StrataXRT vs. Standard Clinical Practice in the Prevention and Treatment of Radiation Dermatitis N/A
Active, not recruiting NCT05594498 - A Study of StrataXRT in the Prevention of Radiation Dermatitis in Breast Cancer Patients N/A
Recruiting NCT04110977 - A Reminder App to Reduce Radiation Dermatitis Rates in Patients With Head-and-Neck Cancer N/A
Recruiting NCT06158347 - Efficacy and Safety of Hyperbaric Oxygen Therapy for Radiation Dermatitis in Patients With Localized Breast Cancer N/A
Recruiting NCT05553392 - StrataXRT Versus Aquaphor for the Prevention and Management of Radiation Dermatitis N/A
Active, not recruiting NCT04268056 - Characterization of Skin Microbiome Profile and it's Correlation to Radiation Dermatitis
Not yet recruiting NCT04888234 - Evaluation the Effectiveness of Ru-Yi-Jin-Huang Powder for the Radiation-induced Dermatitis. Phase 2
Terminated NCT01597921 - A DB Randomized Study of R1 and R2 WaterJel / AloeVera Jell in Prevention of Radiation Dermatitis in Breast Cancer N/A
Completed NCT00481884 - Comparing RadiaPlexRx Hydrogel and Standard-of-Care for Radiation Dermatitis in Breast Cancer Patients Phase 3
Completed NCT03494205 - Urtica Comp. Gel for Prevention and Therapy of Radiation Dermatitis Phase 2
Completed NCT05810194 - Retrospective Cohort Study Comparing a Novel Gel Dressing vs SoC in the Treatment of Radiation Dermatitis
Completed NCT03941665 - Use of Gelronate Gel vs. Aloevera in Preventing/Minimizing Radiation-induced Dermatitis in Breast Cancer Patients N/A
Not yet recruiting NCT02051907 - Clinical Study to Evaluate Safety and Efficacy of KAM1403 Gel to Treat Radiation Dermatitis Phase 2
Completed NCT02839473 - Hydrosorb® Versus Control in the Management of Radio-induced Skin Toxicity: Multicentre Controlled Phase III Randomized Trial Phase 3
Completed NCT00573365 - LED Photomodulation for Prevention of Post-Radiation Treatment Dermatitis N/A
Completed NCT00876642 - Trial Comparing Best Supportive Care to Aloe Vera Gel Phase 3