Epidermal Skin Grafts for Radiation Skin Damage

Overseen By Katie Vogel

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Immunosuppressants

Disqualifiers: Active tanning, Infection, Herpes, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

Duration: 9 visits

34 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

Is 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. ^{1 2 3 6 7}

How 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. ^{8 9 10 11 12}

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.

Research Team

Yen-Lin E Chen, MD

Principal Investigator

Massachusetts General Hospital

Eligibility 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.

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

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

Treatment Details

Interventions

• CelluTome Epidermal Harvesting System

Trial Overview 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.

Participant Groups

Group I: Epidermal Grafting Experimental Treatment 1 Intervention

This irradiated area of the skin will be treated with autologous epidermal grafts

Group II: No treatment Active Control 1 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

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

3M

Industry Sponsor

Trials

160

Recruited

31,600+

Dr. John Banovetz

3M

Chief Medical Officer since 2017

PhD in Inorganic Chemistry from Stanford University, Bachelor's degree in Chemistry from Hamline University

William 'Bill' Brown

3M

Chief Executive Officer

Bachelor's and Master's degrees in Mechanical Engineering from Villanova University, MBA from The Wharton School, University of Pennsylvania

Findings from Research

The automated CelluTome Epidermal Harvesting System successfully harvested viable epidermal grafts from patients with chronic lower extremity wounds, showing a high reepithelialization rate of 88.1% over an average follow-up of 76.4 days.

This method resulted in no complications or scarring at donor sites, with all sites healing completely within 2 weeks, making it a safe and effective alternative to traditional skin grafting techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Epidermal Skin Grafts Over Complex, Chronic Wounds in Patients With Multiple Comorbidities. Fearmonti, RM.[2017]

The new CelluTome tool produced epidermal micrografts with an impressive viability rate of 99.5%, indicating its effectiveness in harvesting skin for grafting purposes.

Participants reported minimal discomfort during the procedure, with an average pain score of only 1.3 out of 5, and 76% to 100% of donor sites healed to match the surrounding skin within 14 days, demonstrating the tool's safety and efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Automated and Minimally Invasive Tool for Generating Autologous Viable Epidermal Micrografts. Osborne, SN., Schmidt, MA., Harper, JR.[2018]

The study demonstrated that using the CelluTome Epidermal Harvesting System to create epidermal micrografts results in viable grafts with minimal discomfort and no scarring at the donor site, based on a trial with 15 healthy volunteers.

These micrografts not only formed at the dermal-epidermal junction but also retained key growth factors and cellular structures necessary for effective wound healing and skin repigmentation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Osborne, SN., Schmidt, MA., Derrick, K., et al.[2018]

In a randomized controlled trial involving 8 patients, epidermal blister grafting showed slightly faster healing of partial-thickness burns compared to standard acellular treatment, indicating its potential efficacy.

The grafting technique resulted in less erythema and better cosmetic outcomes, suggesting a higher quality of healing, with donor sites appearing similar to normal skin after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidermal-cell-based therapy as an adjunct to healing second degree burns-A randomized controlled pilot study. Blome-Eberwein, S., Schwartz, A., Pinataro, C., et al.[2023]

Epidermal grafting is an effective treatment for chronic wounds, showing successful healing in patients who do not respond to standard therapies, and is associated with lower costs and morbidity compared to traditional skin grafting.

The use of the CelluTome™ Epidermal Harvesting System has made epidermal grafting more standardized, reproducible, and convenient, enhancing its application in clinical settings for managing non-healing wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and Economic Benefits of Autologous Epidermal Grafting. Maderal, AD., Kirsner, RS.[2020]

The CelluTome epidermal graft-harvesting device allows for pain-free skin grafts with no noticeable donor site issues in 100% of cases, compared to 25% for conventional split skin grafts (SSG), leading to significantly higher patient satisfaction.

Cost analysis shows that using the CelluTome device is much more economical, costing £431 per patient compared to £1489 for SSG, resulting in substantial annual savings while providing comparable healing outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The CelluTome epidermal graft-harvesting system: a patient-reported outcome measure and cost evaluation study. Smith, OJ., Edmondson, SJ., Bystrzonowski, N., et al.[2021]

Chronic wounds are difficult to heal and require innovative treatments; traditional methods like split-thickness skin grafts (STSGs) are less favored due to discomfort and complications, while new techniques like epidermal grafting offer a promising alternative.

The CelluTome Epidermal Harvesting System allows for quick and painless harvesting of epidermal micrografts at the bedside, making it a more efficient option for promoting healing in chronic wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of epidermal grafts in wounds: a review of an automated epidermal harvesting system. Serena, TE.[2015]

The total skin electron beam technique at Heidelberg University Hospital, using low energy electrons and a specific setup, can achieve a dose uniformity of -4% to +8% across most of the patient's skin.

However, the technique may result in localized overdoses exceeding 20% in small areas, highlighting the importance of precise setup and measurement for effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical and dosimetric aspects of the total skin electron beam technique implemented at Heidelberg University Hospital. Hensley, FW., Major, G., Edel, C., et al.[2021]

In a study involving 36 male Sprague-Dawley rats, AlloDerm grafts implanted in areas exposed to external-beam radiation (EBR) showed no significant differences in graft thickness or neovascularization compared to non-irradiated controls, suggesting that EBR does not adversely affect these parameters.

While fibroblast counts were initially lower in irradiated grafts at week 3, they normalized by week 14, indicating that early post-implantation challenges may resolve over time, and overall graft thickness and fibroblast counts decreased for both irradiated and control grafts as time progressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allograft dermal implant (AlloDerm) in a previously irradiated field. Dubin, MG., Feldman, M., Ibrahim, HZ., et al.[2006]

A 59-year-old woman with cutaneous T-cell lymphoma developed severe radiation dermatitis after receiving a total dose of 36 Gy from electron beam irradiation.

The use of a combined treatment involving topical platelet-derived growth factor gel and hydrophilic copolymer membranes significantly improved her painful and bleeding ulcers, suggesting an effective approach for managing radiation-induced skin injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of chronic radiation ulcers with recombinant platelet-derived growth factor and a hydrophilic copolymer membrane. Wollina, U., Liebold, K., Konrad, H.[2019]

In a study involving 8 minipigs with radiation-injured full-thickness skin defects, wounds treated with human amniotic membrane (HAM) loaded with mesenchymal stem cells (MSCs) and epidermis cells healed 6 to 7 days faster than those treated with oil gauze and 5 to 6 days faster than those treated with simple HAM.

The HAM with MSCs and epidermis cells not only accelerated healing but also resulted in better quality granulation tissue, with more blood vessels and collagen, compared to the other treatment groups, indicating its potential as an effective therapy for complex wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Study on human amniotic membrane loaded with marrow mesenchymal stem cells and epidermis cells in promoting healing of wound combined with radiation injury]. Yan, G., Su, Y., Ai, G.[2018]

External beam radiation (EBR) significantly hinders the recellularization of AlloDerm grafts in the early weeks after treatment, as shown in a study with 36 rats, but this effect equalizes by 12 weeks.

Despite the initial decrease in recellularization, EBR did not negatively impact the overall thickness of the grafts or their long-term survival, indicating that while EBR affects early healing, it does not compromise graft integrity in the long run.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of external beam radiation on the allograft dermal implant. Ibrahim, HZ., Kwiatkowski, TJ., Montone, KT., et al.[2017]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Epidermal Skin Grafts Over Complex, Chronic Wounds in Patients With Multiple Comorbidities. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

An Automated and Minimally Invasive Tool for Generating Autologous Viable Epidermal Micrografts. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

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]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Epidermal-cell-based therapy as an adjunct to healing second degree burns-A randomized controlled pilot study. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Clinical and Economic Benefits of Autologous Epidermal Grafting. [2020]

6. England pubmed.ncbi.nlm.nih.gov

The CelluTome epidermal graft-harvesting system: a patient-reported outcome measure and cost evaluation study. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Use of epidermal grafts in wounds: a review of an automated epidermal harvesting system. [2015]

8. Poland pubmed.ncbi.nlm.nih.gov

Technical and dosimetric aspects of the total skin electron beam technique implemented at Heidelberg University Hospital. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Allograft dermal implant (AlloDerm) in a previously irradiated field. [2006]

10. England pubmed.ncbi.nlm.nih.gov

Treatment of chronic radiation ulcers with recombinant platelet-derived growth factor and a hydrophilic copolymer membrane. [2019]

11. China pubmed.ncbi.nlm.nih.gov

[Study on human amniotic membrane loaded with marrow mesenchymal stem cells and epidermis cells in promoting healing of wound combined with radiation injury]. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Effects of external beam radiation on the allograft dermal implant. [2017]