Epidermal Skin Grafts for Radiation Skin Damage
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Massachusetts General Hospital
Must not be taking: Immunosuppressants
Disqualifiers: Active tanning, Infection, Herpes, Diabetes, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are on immunosuppressive medications or have uncontrolled diabetes, you may not be eligible to participate.
What data supports the effectiveness of the treatment CelluTome Epidermal Harvesting System for radiation skin damage?
The CelluTome Epidermal Harvesting System has been shown to be effective in healing chronic wounds and second-degree burns by creating small skin grafts with minimal discomfort and no scarring at the donor site. This suggests it could be beneficial for treating radiation skin damage as it promotes healing and reduces complications compared to traditional methods.
12345Is the CelluTome Epidermal Harvesting System safe for use in humans?
The CelluTome Epidermal Harvesting System is generally considered safe for use in humans, as it creates epidermal micrografts with minimal discomfort, no scarring, and improved patient satisfaction compared to traditional methods. Studies have shown that it causes minimal donor site damage and does not require anesthesia, making it a less invasive option.
12367How is the CelluTome Epidermal Harvesting System treatment different from other treatments for radiation skin damage?
The CelluTome Epidermal Harvesting System is unique because it uses a minimally invasive technique to harvest thin layers of skin from the patient's own body, which are then grafted onto the damaged area. This approach is different from other treatments that may use external materials or drugs, as it utilizes the patient's own skin to promote healing.
89101112Eligibility Criteria
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.Inclusion Criteria
My treatment area is large enough for the study.
My doctor thinks my wound is suitable for skin grafting.
My radiation injury has a comparable area nearby for treatment comparison.
+3 more
Exclusion Criteria
Participation in another interventional study with potential exposure to an investigational drug within past 30 days
You have mental health issues, are in prison, or currently have problems with drugs or alcohol.
Pregnant females, due to possible discomfort with the procedure even though the procedure is localized and there is no new drug
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo the epidermal grafting procedure using the CelluTome device on radiation-induced wounds
9 visits
9 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, with photographs taken and questionnaires filled out
12 months
Participant Groups
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.
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
CelluTome Epidermal Harvesting System is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as CelluTome Epidermal Harvesting System for:
- Wound healing
- Radiation dermatitis
- Chronic wounds
- Venous ulcers
- Diabetic foot ulcers
🇪🇺 Approved in European Union as CelluTome Epidermal Grafting System for:
- Wound healing
- Radiation dermatitis
- Chronic wounds
- Venous ulcers
- Diabetic foot ulcers
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Massachusetts General Hospital, Wellman Center for PhotomedicineBoston, MA
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Who Is Running the Clinical Trial?
Massachusetts General HospitalLead Sponsor
3MIndustry Sponsor
References
Efficacy of Epidermal Skin Grafts Over Complex, Chronic Wounds in Patients With Multiple Comorbidities. [2017]Epidermal skin grafting presents an alternative to traditional autografts since only epidermal skin is harvested from the donor site. Split-thickness skin grafts are associated with difficulties at the donor site, including excessive pain, delayed healing, fluid loss, and unsatisfactory cosmetic results - all exacerbated in patients with comorbidities. A new automated epidermal harvesting tool (CelluTome Epidermal Harvesting System, KCI, an Acelity company, San Antonio, TX) involves concurrent application of heat and suction to normal skin to produce epidermal grafts. This article outlines the author's experience using this automated epidermal harvesting tool to harvest epidermal grafts and apply them on 23 chronic lower extremity wounds of patients with multiple comorbidities.
An Automated and Minimally Invasive Tool for Generating Autologous Viable Epidermal Micrografts. [2018]A new epidermal harvesting tool (CelluTome; Kinetic Concepts, Inc, San Antonio, Texas) created epidermal micrografts with minimal donor site damage, increased expansion ratios, and did not require the use of an operating room. The tool, which applies both heat and suction concurrently to normal skin, was used to produce epidermal micrografts that were assessed for uniform viability, donor-site healing, and discomfort during and after the epidermal harvesting procedure.
Epidermal micrografts produced via an automated and minimally invasive tool form at the dermal/epidermal junction and contain proliferative cells that secrete wound healing growth factors. [2018]The aim of this scientific study was to assess epidermal micrografts for formation at the dermal-epidermal (DE) junction, cellular outgrowth, and growth factor secretion. Epidermal harvesting is an autologous option that removes only the superficial epidermal layer of the skin, considerably limiting donor site damage and scarring. Use of epidermal grafting in wound healing has been limited because of tedious, time-consuming, and inconsistent methodologies. Recently, a simplified, automated epidermal harvesting tool (CelluTome Epidermal Harvesting System; Kinetic Concepts Inc, San Antonio, Texas) that applies heat and suction concurrently to produce epidermal micrografts has become commercially available. The new technique of epidermal harvesting was shown to create viable micrografts with minimal patient discomfort and no donor-site scarring.
Epidermal-cell-based therapy as an adjunct to healing second degree burns-A randomized controlled pilot study. [2023]Healing of partial-thickness (2a and 2b) burns is notoriously unpredictable as far as healing time, scarring and (hypo)pigmentation is concerned. Epidermal blister grafting is an autologous grafting technique involving transfer of epidermal islands without dermal elements. Cellutome™ is an FDA-acknowledged epidermal harvesting device. This proof-of-concept study evaluates whether blister grafting of partial-thickness burns results in improved healing compared to standard acellular treatment.
Clinical and Economic Benefits of Autologous Epidermal Grafting. [2020]Chronic wounds are an increasingly prevalent disease with a significant healthcare burden. These wounds often do not respond to standard of care therapy alone, requiring the use of adjuvant therapies. Epidermal grafting, previously utilized primarily for correction of leukoderma, is increasingly being recognized as a beneficial therapy for wounds, both acute and chronic. Epidermal grafting has been shown to be effective in the management of chronic wounds, with successful healing in refractory patients. It has not only been shown to be effective, but it is also associated with lower cost and morbidity than traditional skin grafting techniques as well as improved donor site healing. Through the use of a novel epidermal harvesting system, the CelluTome™ Epidermal Harvesting System (KCI, an Acelity company, San Antonio, TX), this treatment modality has become more standardized, reproducible, and easy to use as well as less time consuming, making its use in the clinical setting more convenient and beneficial. Epidermal grafting, therefore, represents a promising, efficacious, and cost-effective option for treatment of refractory non-healing wounds.
The CelluTome epidermal graft-harvesting system: a patient-reported outcome measure and cost evaluation study. [2021]Conventional split skin grafts (SSG) require anaesthesia, specialist equipment and can have high donor site (DS) morbidity. The CelluTome epidermal graft-harvesting device is a novel alternative, providing pain-free epidermal skin grafts (ESG) in the outpatient setting, with projected minimal DS trauma and improved patient satisfaction. This study aimed to compare ESG with SSG by evaluating patient-related outcome measures (PROMs) and the cost implications of both. Twenty patients answered a graft satisfaction questionnaire that evaluated: donor/graft site noticeability, aesthetic concerns, adverse problems and patient satisfaction. Cost/patient was calculated based on total operative expenses and five clinic follow-ups. In 100% of the ESG cases, there were no DS noticeability or adverse problems compared to 25% in the SSG group. Complete satisfaction with DS appearance was observed in 100% of the ESG cases (50% SSG). Noticeability, adverse problems and overall satisfaction were significantly better in ESG cases (P
Use of epidermal grafts in wounds: a review of an automated epidermal harvesting system. [2015]Chronic wounds continue to present a significant challenge to health-care providers across the globe. Unlike acute wounds, chronic wounds do not proceed through an orderly process of repair. In recent years, a number of wound healing treatments, such as dermal replacement scaffolds and negative pressure wound therapy, have promoted wound healing by stimulating the formation of granulation tissue. However, until recently there were few modalities designed to promote epithelialisation of a fully granulated wound. Split-thickness skin grafts (STSGs) have long been the gold standard for the management of acute wounds, but have not gained favour in the treatment of chronic wounds for several reasons: discomfort associated with the donor site, the creation of a second wound (donor site) in a patient with poor wound-healing potential, and a lack of documented efficacy for the procedure. Epidermal grafting does not have some of the limitations encountered with STSG; however, it has not gained wide acceptance, as previous harvesting techniques were cumbersome and time-consuming. A novel automated epidermal harvesting system, CelluTome Epidermal Harvesting System (KCI, an Acelity company, San Antonio, TX, USA), was commercially introduced in 2013. The system yields up to 128 epidermal micrografts that can be easily harvested at the bedside without anaesthesia and transferred to the recipient site. The harvesting technique and the use of epidermal grafts in wounds are reviewed here.
Technical and dosimetric aspects of the total skin electron beam technique implemented at Heidelberg University Hospital. [2021]To give a technical description and present the dosimetric proporties of the total skin electron beam technique implemented at Heidelberg University Hospital.
Allograft dermal implant (AlloDerm) in a previously irradiated field. [2006]To evaluate the integration of AlloDerm (LifeCell Corp., The Woodlands, TX) in a field exposed to external-beam radiation (EBR) by analyzing graft thickness, fibroblast recellularization, and neovascularization.
Treatment of chronic radiation ulcers with recombinant platelet-derived growth factor and a hydrophilic copolymer membrane. [2019]We report on a 59-year-old woman suffering from cutaneous T-cell lymphoma of the mycosis fungoides type, who developed chronic ulcerating radiation dermatitis after total body electron beam irradiation with a cumulative dose of 36 Gy. The painful and easily bleeding ulcers could be markedly improved using a combined approach with topical platelet-derived growth factor gel and hydrophilic copolymer membranes.
[Study on human amniotic membrane loaded with marrow mesenchymal stem cells and epidermis cells in promoting healing of wound combined with radiation injury]. [2018]To investigate the results of human amniotic membrane (HAM) which are loaded with marrow mesenchymal stem cells (MSCs) and epidermis cells in treating full-thickness skin defect combined with radiation injury.
Effects of external beam radiation on the allograft dermal implant. [2017]The purpose of this study was to define the effects of external beam radiation (EBR) on AlloDerm (LifeCell Corp) through the analysis of graft thickness, fibroblast recellularization, and neovascularization as a function of time.